<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03809104</url>
  </required_header>
  <id_info>
    <org_study_id>18-034</org_study_id>
    <nct_id>NCT03809104</nct_id>
  </id_info>
  <brief_title>VR-based Rehabilitation in the Treatment and Prevention of Sarcopenia of Older Residents</brief_title>
  <official_title>Virtual Reality-based Rehabilitation in the Treatment and Prevention of Sarcopenia of Older Residents in Caring Facilities - a Pilot Study in Rural Southern Taiwan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cishan Hospital, Ministry of Health and Welfare</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cishan Hospital, Ministry of Health and Welfare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Sarcopenia is the progressive loss of skeletal muscle mass and decline of muscle function&#xD;
      associated with aging. The prevalence of sarcopenia among people older than 65 years old in&#xD;
      Taiwan is over 20%. Sarcopenia is one of the most important causes of functional decline and&#xD;
      loss of independence, even mortality in older adults. Literatures have found that resistant&#xD;
      or aerobic exercise could improve muscle strength and function in older adults. However, due&#xD;
      to shortage in healthcare provider, long-term rehabilitation program is difficult to provide&#xD;
      in senior caring facilities of countryside in Taiwan.&#xD;
&#xD;
      Method:&#xD;
&#xD;
      The investigators conducted a study to screen sarcopenia among residents in senior caring&#xD;
      facilities in Ci-Shan and Mei-Nong district, Kaohsiung, Taiwan. Older adults diagnosed as&#xD;
      sarcopenia after screening received a virtual reality (VR)-based rehabilitation program that&#xD;
      lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with&#xD;
      progressive resistant training and functional movement of dominant upper (UE) limb. Criteria&#xD;
      of sarcopenia including (1) handgrip strength of dominant hand (HGS), (2) walking speed, and&#xD;
      (3) skeletal muscle mass of 4 extremities (SKM), were measured as primary outcomes. (1) Range&#xD;
      of motions in dominant UE (ROM), (2) maximal voluntary isometric contraction of&#xD;
      biceps/triceps brachial muscles of dominant side (MVC of biceps/triceps), and (3) box and&#xD;
      block test (BBT), were measured as secondary outcomes before and after the programs.&#xD;
&#xD;
      Anticipated benefits:&#xD;
&#xD;
      VR-based rehabilitation program could enhance the motivation toward rehabilitation of older&#xD;
      adults and reduce the health provider demand of senior caring facilities in countryside. It&#xD;
      could also increase muscle mass, strength, and functional ability of dominant UE and reach&#xD;
      the clinical effectiveness in treatment of sarcopenia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sarcopenia is an involuntary loss of skeletal muscle mass and strength related with age. It&#xD;
      is one of the most important causes of functional decline and loss of independence in older&#xD;
      adults. In Taiwan, more than 20% of elders over the age of 65 are diagnosed with sarcopenia,&#xD;
      and most of them are institutionalized. However, due to the lack of medical resources and&#xD;
      medical professions, only a few elders with sarcopenia have received adequate rehabilitation.&#xD;
      Recently, there are prevalence of research about integrating Virtual-Reality (VR) into&#xD;
      various rehabilitations. Most of them have found that these VR-based rehabilitation can boost&#xD;
      the motivation for participation, decrease the use of medical resources, and effectively&#xD;
      contribute to the recovery of the patients. Inspired from these results, I think it might be&#xD;
      interesting to integrate VR into the sarcopenia rehabilitation of elders.&#xD;
&#xD;
      This research has combined existed VR games with progressive resistance exercise of the upper&#xD;
      limbs and exercises for the function movement system (F.M.S) of the upper limbs, establishing&#xD;
      a VR-based rehabilitation program designed for sarcopenia elders. The rehabilitation programs&#xD;
      spans for 8 weeks, and is conducted at least twice a week for each subject. The research&#xD;
      question of this research is: &quot;What is the impact of Virtual Reality-based rehabilitation on&#xD;
      upper limb sarcopenia patient?&quot;.&#xD;
&#xD;
      The primary outcome of this research examines the change in muscle mass (measured by skeletal&#xD;
      mass index, fat mass index and fat-free mass index), hand grip strength of the dominant hand&#xD;
      and gait speed. The secondary outcome of this research examines the the change in range of&#xD;
      motion of the upper limbs (shoulder flexion, shoulder external rotation, shoulder abduction,&#xD;
      elbow flexion, elbow extension, elbow supination, elbow pronation, wrist flexion, wrist&#xD;
      extension) and the functional ability of the upper limbs (measured by box and block test).&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
        1. After two months of participating in the rehabilitation program, the primary outcomes&#xD;
           (muscle mass, hand grip strength, and gait speed), show statistically significant&#xD;
           increase.&#xD;
&#xD;
        2. After two months of participating in the rehabilitation program, the secondary outcomes&#xD;
           (change of range of motion of the upper limbs and functional ability of upper limbs)&#xD;
           show statistically significant increase.&#xD;
&#xD;
      Flow of the research:&#xD;
&#xD;
        1. Sarcopenia patients are first selected from the daycare and nursing home of Chi-Shan&#xD;
           Hospital.&#xD;
&#xD;
        2. The first period of rehabilitation begins right after the selection and lasts for one&#xD;
           month.&#xD;
&#xD;
        3. The first evaluation begins after the first period of rehabilitation&#xD;
&#xD;
        4. The second period of rehabilitation begins and lasts for one month.&#xD;
&#xD;
        5. The second evaluation begins after the second period of rehabilitation.&#xD;
&#xD;
      Apparatus in this study:&#xD;
&#xD;
        1. Leap Motion Controller&#xD;
&#xD;
        2. Oculus Rift headset (CV1)&#xD;
&#xD;
        3. Oculus Sensors (a pair)&#xD;
&#xD;
        4. (oculus) Touch Controllers&#xD;
&#xD;
        5. Omron KARADA Scan Body Composition &amp; Scale (HBF-701)&#xD;
&#xD;
        6. JAMAR Hand Dynamometer&#xD;
&#xD;
        7. MicroFET3 Dynamometer and ROM Evaluator&#xD;
&#xD;
        8. Goniometer&#xD;
&#xD;
        9. Box and Block Test Apparatus&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2019</start_date>
  <completion_date type="Actual">October 8, 2019</completion_date>
  <primary_completion_date type="Actual">September 6, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>elder residents in caring facilities, including nursing home and daycare center 15 participants in nursing home and 15 participants in daycare center</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Hand-grip Strength of the Dominant Hand Between the Third Month and the Baseline</measure>
    <time_frame>3 months after the intervention of the virtual reality-based rehabilitation programs</time_frame>
    <description>The measurements of the HGS were determined by means of the JAMAR-Dynamometer. The forearm was held in neutral position and the wrist at a 0 to 30° extension. The instrument was held freely: neither the hand nor the forearm was allowed to rest on a surface. Three measurements were done and recorded as the average of the three measurements and the participants rested for 1 minute in between measurements.&#xD;
The change was calculated by the data of the third month minus the baseline data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Walking Speed Between the Third Month and the Baseline</measure>
    <time_frame>3 months after the intervention of the virtual reality-based rehabilitation programs</time_frame>
    <description>Timing starts after the patient starts walking and stops at the point when a patient reaches a distance of 6 meters. The gait speed in measured twice and the final measurement is the average of the two scores. The patient is allowed to rest for 10 minutes in between measurement.&#xD;
The change was calculated by the data of the third month minus the baseline data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Appendicular Skeletal Muscle Mass Between the Third Month and the Baseline</measure>
    <time_frame>3 months after the intervention of the virtual reality-based rehabilitation programs</time_frame>
    <description>Appendicular skeletal muscle mass (ASM) is deﬁned by the sum of the lean soft tissue mass of four limbs. Appendicular skeletal muscle mass index (ASMI) is defined as ASM (kg) divided by squared height (m).The body composition was measured via bio-electrical impedance analysis by Omron KARADA Scan Body Composition &amp; Scale (HBF-701). A participant was considered to have low muscle mass if his or her ASMI was below -2 standard deviations of the reference defined in previous studies from Taiwan (6.76 kg/m2 for men and 5.28 kg/m2 for women). Participants with ASMI in the lowest 20% of the sex-specific distribution were considered to have low muscle mass, too. Increased of ASMI after virtual reality-based rehabilitation programs is considered to be better.&#xD;
The change was calculated by the data of the third month minus the baseline data.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Range of Motions in Dominant Upper Extremity</measure>
    <time_frame>baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs</time_frame>
    <description>Use goniometry for range of motion measurement. The joints measured include shoulder, elbow, and wrist of the dominant side.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength of Biceps Brachii and Triceps Brachii of the Dominant Upper Extremity</measure>
    <time_frame>baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs</time_frame>
    <description>This research uses MicroFET3 to measure the the maximal voluntary isometric contraction of the biceps and triceps. Measurements are taken 2 times and the results are averaged. MicroFET3 is a electronic hand-held dynamometer that can measure muscle strength. The range of muscle testing of the device ranges from 0-150 lbs force.(Digital Dynamometer and Inclinometer | MicroFET®3) .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Box and Block Test</measure>
    <time_frame>baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs</time_frame>
    <description>The Box and Block Test (BBT) can measure the unilateral gross manual dexterity. The set up of the BBT test includes a wooden box with 150 wooden blocks inside. The wooden box is divided into two compartments. One filled with blocks, and the other is empty.During this test, the patient is seated upright in a chair and needs to transfer the wooden blocks, one by one, from one compartment to the other. The patient is scored based on the number of blocks he or she can transferred from one compartment to the other in 60 seconds.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Sarcopenia</condition>
  <arm_group>
    <arm_group_label>elderly with sarcopenia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Virtual reality-based rehabilitation programs</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Virtual reality-based rehabilitation programs</intervention_name>
    <description>A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer.</description>
    <arm_group_label>elderly with sarcopenia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All the rehabilitation subjects are selected from the nursing home and day care center&#xD;
             of Chi-Shan Hospital and over 60 years of age.&#xD;
&#xD;
          2. Participants meet the diagnostic criteria of sarcopenia based on the The Asian Working&#xD;
             Group of Sarcopenia:&#xD;
&#xD;
        (1) Muscle mass lower than norm for two standard deviations and (2) Grip strength: men&#xD;
        lower than 26 kg and women lower than 18 kg (measured by handgrip denominator used in&#xD;
        physical examination) or an average gait speed lower than 0.8m/ sec.&#xD;
&#xD;
        3. Cognitive functions and physical strength are capable of completing the rehabilitation&#xD;
        program which lasts for 30 minutes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The ones who have uncontrollable high blood pressure, are recently infected, have&#xD;
             major cardiovascular diseases and are prohibited to participate in sports exercise by&#xD;
             the American College of Sports Medicine are excluded from the selection.&#xD;
&#xD;
          2. The ones who are bedridden are excluded from the selection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cishan Hospital, Ministry of health and welfare</name>
      <address>
        <city>Kaohsiung</city>
        <zip>84247</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Ali S, Garcia JM. Sarcopenia, cachexia and aging: diagnosis, mechanisms and therapeutic options - a mini-review. Gerontology. 2014;60(4):294-305. doi: 10.1159/000356760. Epub 2014 Apr 8.</citation>
    <PMID>24731978</PMID>
  </reference>
  <reference>
    <citation>Frontera WR, Hughes VA, Fielding RA, Fiatarone MA, Evans WJ, Roubenoff R. Aging of skeletal muscle: a 12-yr longitudinal study. J Appl Physiol (1985). 2000 Apr;88(4):1321-6. doi: 10.1152/jappl.2000.88.4.1321.</citation>
    <PMID>10749826</PMID>
  </reference>
  <reference>
    <citation>Lexell J. Human aging, muscle mass, and fiber type composition. J Gerontol A Biol Sci Med Sci. 1995 Nov;50 Spec No:11-6. doi: 10.1093/gerona/50a.special_issue.11.</citation>
    <PMID>7493202</PMID>
  </reference>
  <reference>
    <citation>Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96. doi: 10.1046/j.1532-5415.2002.50216.x.</citation>
    <PMID>12028177</PMID>
  </reference>
  <reference>
    <citation>Janssen I, Shepard DS, Katzmarzyk PT, Roubenoff R. The healthcare costs of sarcopenia in the United States. J Am Geriatr Soc. 2004 Jan;52(1):80-5. doi: 10.1111/j.1532-5415.2004.52014.x.</citation>
    <PMID>14687319</PMID>
  </reference>
  <reference>
    <citation>Chen LK, Liu LK, Woo J, Assantachai P, Auyeung TW, Bahyah KS, Chou MY, Chen LY, Hsu PS, Krairit O, Lee JS, Lee WJ, Lee Y, Liang CK, Limpawattana P, Lin CS, Peng LN, Satake S, Suzuki T, Won CW, Wu CH, Wu SN, Zhang T, Zeng P, Akishita M, Arai H. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb;15(2):95-101. doi: 10.1016/j.jamda.2013.11.025.</citation>
    <PMID>24461239</PMID>
  </reference>
  <reference>
    <citation>Lo YC, Wahlqvist ML, Huang YC, Chuang SY, Wang CF, Lee MS. Medical costs of a low skeletal muscle mass are modulated by dietary diversity and physical activity in community-dwelling older Taiwanese: a longitudinal study. Int J Behav Nutr Phys Act. 2017 Mar 14;14(1):31. doi: 10.1186/s12966-017-0487-x.</citation>
    <PMID>28288651</PMID>
  </reference>
  <reference>
    <citation>Yarasheski KE, Pak-Loduca J, Hasten DL, Obert KA, Brown MB, Sinacore DR. Resistance exercise training increases mixed muscle protein synthesis rate in frail women and men &gt;/=76 yr old. Am J Physiol. 1999 Jul;277(1):E118-25. doi: 10.1152/ajpendo.1999.277.1.E118.</citation>
    <PMID>10409135</PMID>
  </reference>
  <reference>
    <citation>Chen KM, Li CH, Chang YH, Huang HT, Cheng YY. An elastic band exercise program for older adults using wheelchairs in Taiwan nursing homes: a cluster randomized trial. Int J Nurs Stud. 2015 Jan;52(1):30-8. doi: 10.1016/j.ijnurstu.2014.06.005. Epub 2014 Jun 19.</citation>
    <PMID>25037651</PMID>
  </reference>
  <reference>
    <citation>Liu CJ, Latham NK. Progressive resistance strength training for improving physical function in older adults. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):CD002759. doi: 10.1002/14651858.CD002759.pub2.</citation>
    <PMID>19588334</PMID>
  </reference>
  <reference>
    <citation>Park DS, Lee DG, Lee K, Lee G. Effects of Virtual Reality Training using Xbox Kinect on Motor Function in Stroke Survivors: A Preliminary Study. J Stroke Cerebrovasc Dis. 2017 Oct;26(10):2313-2319. doi: 10.1016/j.jstrokecerebrovasdis.2017.05.019. Epub 2017 Jun 9.</citation>
    <PMID>28606661</PMID>
  </reference>
  <reference>
    <citation>Ilg W, Schatton C, Schicks J, Giese MA, Schols L, Synofzik M. Video game-based coordinative training improves ataxia in children with degenerative ataxia. Neurology. 2012 Nov 13;79(20):2056-60. doi: 10.1212/WNL.0b013e3182749e67. Epub 2012 Oct 31.</citation>
    <PMID>23115212</PMID>
  </reference>
  <reference>
    <citation>Garcia JA, Felix Navarro K, Schoene D, Smith ST, Pisan Y. Exergames for the elderly: towards an embedded Kinect-based clinical test of falls risk. Stud Health Technol Inform. 2012;178:51-7.</citation>
    <PMID>22797019</PMID>
  </reference>
  <reference>
    <citation>Bohannon RW. Test-retest reliability of the MicroFET 4 hand-grip dynamometer. Physiother Theory Pract. 2006 Sep;22(4):219-21. doi: 10.1080/09593980600822875.</citation>
    <PMID>16920680</PMID>
  </reference>
  <reference>
    <citation>Stark T, Walker B, Phillips JK, Fejer R, Beck R. Hand-held dynamometry correlation with the gold standard isokinetic dynamometry: a systematic review. PM R. 2011 May;3(5):472-9. doi: 10.1016/j.pmrj.2010.10.025.</citation>
    <PMID>21570036</PMID>
  </reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <results_first_submitted>November 13, 2019</results_first_submitted>
  <results_first_submitted_qc>January 17, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 21, 2020</results_first_posted>
  <last_update_submitted>January 17, 2020</last_update_submitted>
  <last_update_submitted_qc>January 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cishan Hospital, Ministry of Health and Welfare</investigator_affiliation>
    <investigator_full_name>Sheng-Hui Tuan</investigator_full_name>
    <investigator_title>Attending Physician of Department of Rehabilitation</investigator_title>
  </responsible_party>
  <keyword>virtual reality</keyword>
  <keyword>sarcopenia</keyword>
  <keyword>elderly</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcopenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT03809104/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT03809104/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Older adults aged more than 60 and lived in the nursing home or went to daycare center regularly in rural southern Taiwan were recruited for screening.All the residents with sufficient cognitive function and physical fitness to perform training that lasts for 30 minutes and meeting the criteria of sarcopenia by AWGS.</recruitment_details>
      <pre_assignment_details>A total of 43 participants were recruited for VR-REH. Among them, 40 patients completed the study and 3 patients withdrew during the study period (2 dropped out during the visit at 4 weeks due to hospitalization and 1 withdrew at 8 weeks due to case-closed from daycare center).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Elderly With Sarcopenia</title>
          <description>Virtual reality-based rehabilitation programs&#xD;
Virtual reality-based rehabilitation programs: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Elderly With Sarcopenia</title>
          <description>Virtual reality-based rehabilitation programs&#xD;
Virtual reality-based rehabilitation programs: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74.57" spread="12.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <description>A total of 43 participants were recruited initially. Among them, 40 patients completed the study and 3 patients withdrew during the study period (2 dropped out before the 4th week due to hospitalization and 1 withdrew before the 4th week due to case-closed from daycare center). Therefore, the data we measured and analyzed were all from the 40 patients who completed the study.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Taiwan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="156.97" spread="8.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.74" spread="10.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change of Hand-grip Strength of the Dominant Hand Between the Third Month and the Baseline</title>
        <description>The measurements of the HGS were determined by means of the JAMAR-Dynamometer. The forearm was held in neutral position and the wrist at a 0 to 30° extension. The instrument was held freely: neither the hand nor the forearm was allowed to rest on a surface. Three measurements were done and recorded as the average of the three measurements and the participants rested for 1 minute in between measurements.&#xD;
The change was calculated by the data of the third month minus the baseline data.</description>
        <time_frame>3 months after the intervention of the virtual reality-based rehabilitation programs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Elderly With Sarcopenia</title>
            <description>Virtual reality-based rehabilitation programs&#xD;
Virtual reality-based rehabilitation programs: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer.</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Hand-grip Strength of the Dominant Hand Between the Third Month and the Baseline</title>
          <description>The measurements of the HGS were determined by means of the JAMAR-Dynamometer. The forearm was held in neutral position and the wrist at a 0 to 30° extension. The instrument was held freely: neither the hand nor the forearm was allowed to rest on a surface. Three measurements were done and recorded as the average of the three measurements and the participants rested for 1 minute in between measurements.&#xD;
The change was calculated by the data of the third month minus the baseline data.</description>
          <units>kg</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.02" spread="1.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change of Walking Speed Between the Third Month and the Baseline</title>
        <description>Timing starts after the patient starts walking and stops at the point when a patient reaches a distance of 6 meters. The gait speed in measured twice and the final measurement is the average of the two scores. The patient is allowed to rest for 10 minutes in between measurement.&#xD;
The change was calculated by the data of the third month minus the baseline data.</description>
        <time_frame>3 months after the intervention of the virtual reality-based rehabilitation programs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Elderly With Sarcopenia</title>
            <description>Virtual reality-based rehabilitation programs&#xD;
Virtual reality-based rehabilitation programs: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer.</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Walking Speed Between the Third Month and the Baseline</title>
          <description>Timing starts after the patient starts walking and stops at the point when a patient reaches a distance of 6 meters. The gait speed in measured twice and the final measurement is the average of the two scores. The patient is allowed to rest for 10 minutes in between measurement.&#xD;
The change was calculated by the data of the third month minus the baseline data.</description>
          <units>meter/second</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change of Appendicular Skeletal Muscle Mass Between the Third Month and the Baseline</title>
        <description>Appendicular skeletal muscle mass (ASM) is deﬁned by the sum of the lean soft tissue mass of four limbs. Appendicular skeletal muscle mass index (ASMI) is defined as ASM (kg) divided by squared height (m).The body composition was measured via bio-electrical impedance analysis by Omron KARADA Scan Body Composition &amp; Scale (HBF-701). A participant was considered to have low muscle mass if his or her ASMI was below -2 standard deviations of the reference defined in previous studies from Taiwan (6.76 kg/m2 for men and 5.28 kg/m2 for women). Participants with ASMI in the lowest 20% of the sex-specific distribution were considered to have low muscle mass, too. Increased of ASMI after virtual reality-based rehabilitation programs is considered to be better.&#xD;
The change was calculated by the data of the third month minus the baseline data.</description>
        <time_frame>3 months after the intervention of the virtual reality-based rehabilitation programs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Elderly With Sarcopenia</title>
            <description>Virtual reality-based rehabilitation programs&#xD;
Virtual reality-based rehabilitation programs: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer.</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Appendicular Skeletal Muscle Mass Between the Third Month and the Baseline</title>
          <description>Appendicular skeletal muscle mass (ASM) is deﬁned by the sum of the lean soft tissue mass of four limbs. Appendicular skeletal muscle mass index (ASMI) is defined as ASM (kg) divided by squared height (m).The body composition was measured via bio-electrical impedance analysis by Omron KARADA Scan Body Composition &amp; Scale (HBF-701). A participant was considered to have low muscle mass if his or her ASMI was below -2 standard deviations of the reference defined in previous studies from Taiwan (6.76 kg/m2 for men and 5.28 kg/m2 for women). Participants with ASMI in the lowest 20% of the sex-specific distribution were considered to have low muscle mass, too. Increased of ASMI after virtual reality-based rehabilitation programs is considered to be better.&#xD;
The change was calculated by the data of the third month minus the baseline data.</description>
          <units>kg/meter square</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.21" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Range of Motions in Dominant Upper Extremity</title>
        <description>Use goniometry for range of motion measurement. The joints measured include shoulder, elbow, and wrist of the dominant side.</description>
        <time_frame>baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Elderly With Sarcopenia</title>
            <description>Virtual reality-based rehabilitation programs&#xD;
Virtual reality-based rehabilitation programs: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer.</description>
          </group>
        </group_list>
        <measure>
          <title>Range of Motions in Dominant Upper Extremity</title>
          <description>Use goniometry for range of motion measurement. The joints measured include shoulder, elbow, and wrist of the dominant side.</description>
          <units>degree</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>shoulder flexion (baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130.36" spread="14.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>shoulder flexion (the first month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139.07" spread="11.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>shoulder flexion (the second month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="143.07" spread="8.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>shoulder flexion (the third month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="149.79" spread="8.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>shoulder external rotation (baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.68" spread="10.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>shoulder external rotation (the first month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.50" spread="5.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>shoulder external rotation (the second month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.36" spread="4.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>shoulder external rotation (the third month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.50" spread="3.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>shoulder abduction (baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128.79" spread="25.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>shoulder abduction (the first month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130.71" spread="15.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>shoulder abduction (the second month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="138.21" spread="9.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>shoulder abduction (the third month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141.93" spread="9.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>elbow flexion (baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120.29" spread="10.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>elbow flexion (the first month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117.29" spread="7.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>elbow flexion (the secondt month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118.79" spread="8.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>elbow flexion (the third month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119.93" spread="6.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>elbow extension (baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.71" spread="2.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>elbow extension (the first month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.43" spread="1.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>elbow extension (the second month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.79" spread="1.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>elbow extension (the third month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.64" spread="0.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>elbow supination (baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.07" spread="15.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>elbow supination (the first month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.64" spread="9.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>elbow supination (the second month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.14" spread="9.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>elbow supination (the third month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.86" spread="9.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>elbow pronation (baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.43" spread="18.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>elbow pronation (the first month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.43" spread="13.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>elbow pronation (the second month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.21" spread="13.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>elbow pronation (the third month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.21" spread="9.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>wrist flexion (baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.86" spread="9.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>wrist flexion (the first month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.36" spread="8.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>wrist flexion (the second month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.07" spread="5.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>wrist flexion (the third month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.71" spread="4.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>wrist extension (baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.50" spread="10.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>wrist extension (the first month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.64" spread="12.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>wrist extension (the second month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.93" spread="9.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>wrist extension (the third month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.86" spread="7.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Strength of Biceps Brachii and Triceps Brachii of the Dominant Upper Extremity</title>
        <description>This research uses MicroFET3 to measure the the maximal voluntary isometric contraction of the biceps and triceps. Measurements are taken 2 times and the results are averaged. MicroFET3 is a electronic hand-held dynamometer that can measure muscle strength. The range of muscle testing of the device ranges from 0-150 lbs force.(Digital Dynamometer and Inclinometer | MicroFET®3) .</description>
        <time_frame>baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Elderly With Sarcopenia</title>
            <description>Virtual reality-based rehabilitation programs&#xD;
Virtual reality-based rehabilitation programs: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer.</description>
          </group>
        </group_list>
        <measure>
          <title>Strength of Biceps Brachii and Triceps Brachii of the Dominant Upper Extremity</title>
          <description>This research uses MicroFET3 to measure the the maximal voluntary isometric contraction of the biceps and triceps. Measurements are taken 2 times and the results are averaged. MicroFET3 is a electronic hand-held dynamometer that can measure muscle strength. The range of muscle testing of the device ranges from 0-150 lbs force.(Digital Dynamometer and Inclinometer | MicroFET®3) .</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Strength of biceps brachii muscle (baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.03" spread="1.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strength of biceps brachii muscle (the 1st month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.48" spread="1.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strength of biceps brachii muscle (the 2nd month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.80" spread="1.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strength of biceps brachii muscle (the 3rd month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.44" spread="1.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strength of triceps brachii muscle (baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.06" spread="1.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strength of triceps brachii muscle (the 1st month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.55" spread="1.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strength of triceps brachii muscle (the 2nd month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.75" spread="1.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strength of triceps brachii muscle (the 3rd month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.15" spread="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Box and Block Test</title>
        <description>The Box and Block Test (BBT) can measure the unilateral gross manual dexterity. The set up of the BBT test includes a wooden box with 150 wooden blocks inside. The wooden box is divided into two compartments. One filled with blocks, and the other is empty.During this test, the patient is seated upright in a chair and needs to transfer the wooden blocks, one by one, from one compartment to the other. The patient is scored based on the number of blocks he or she can transferred from one compartment to the other in 60 seconds.</description>
        <time_frame>baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Elderly With Sarcopenia</title>
            <description>Virtual reality-based rehabilitation programs&#xD;
Virtual reality-based rehabilitation programs: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer.</description>
          </group>
        </group_list>
        <measure>
          <title>Box and Block Test</title>
          <description>The Box and Block Test (BBT) can measure the unilateral gross manual dexterity. The set up of the BBT test includes a wooden box with 150 wooden blocks inside. The wooden box is divided into two compartments. One filled with blocks, and the other is empty.During this test, the patient is seated upright in a chair and needs to transfer the wooden blocks, one by one, from one compartment to the other. The patient is scored based on the number of blocks he or she can transferred from one compartment to the other in 60 seconds.</description>
          <units>boxes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>number (baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.86" spread="12.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>number (the first month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.14" spread="13.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>number (the second month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.04" spread="9.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>number (the third month)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.57" spread="12.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Elderly With Sarcopenia</title>
          <description>Virtual reality-based rehabilitation programs&#xD;
Virtual reality-based rehabilitation programs: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>light-headedness</sub_title>
                <description>The symptom presented at the last 20 minutes of each session of the program and it subsided after stopping the virtual reality device.</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>sore eyes</sub_title>
                <description>the symptom developed after the 30-minute VR-based program and it resolved after resting</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Ms. Chia-Yu Wei</name_or_title>
      <organization>Ci-Shan Hospital, Health and Welfare of Minister, Taiwan</organization>
      <phone>+886-7-6615523 ext 1729</phone>
      <email>ivywei@chis.mohw.gov.tw</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03809104
org study id: 18-034
nct id: NCT03809104
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background:

      Sarcopenia is the progressive loss of skeletal muscle mass and decline of muscle function
      associated with aging. The prevalence of sarcopenia among people older than 65 years old in
      Taiwan is over 20%. Sarcopenia is one of the most important causes of functional decline and
      loss of independence, even mortality in older adults. Literatures have found that resistant
      or aerobic exercise could improve muscle strength and function in older adults. However, due
      to shortage in healthcare provider, long-term rehabilitation program is difficult to provide
      in senior caring facilities of countryside in Taiwan.

      Method:

      The investigators conducted a study to screen sarcopenia among residents in senior caring
      facilities in Ci-Shan and Mei-Nong district, Kaohsiung, Taiwan. Older adults diagnosed as
      sarcopenia after screening received a virtual reality (VR)-based rehabilitation program that
      lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with
      progressive resistant training and functional movement of dominant upper (UE) limb. Criteria
      of sarcopenia including (1) handgrip strength of dominant hand (HGS), (2) walking speed, and
      (3) skeletal muscle mass of 4 extremities (SKM), were measured as primary outcomes. (1) Range
      of motions in dominant UE (ROM), (2) maximal voluntary isometric contraction of
      biceps/triceps brachial muscles of dominant side (MVC of biceps/triceps), and (3) box and
      block test (BBT), were measured as secondary outcomes before and after the programs.

      Anticipated benefits:

      VR-based rehabilitation program could enhance the motivation toward rehabilitation of older
      adults and reduce the health provider demand of senior caring facilities in countryside. It
      could also increase muscle mass, strength, and functional ability of dominant UE and reach
      the clinical effectiveness in treatment of sarcopenia.
Sarcopenia is an involuntary loss of skeletal muscle mass and strength related with age. It
      is one of the most important causes of functional decline and loss of independence in older
      adults. In Taiwan, more than 20% of elders over the age of 65 are diagnosed with sarcopenia,
      and most of them are institutionalized. However, due to the lack of medical resources and
      medical professions, only a few elders with sarcopenia have received adequate rehabilitation.
      Recently, there are prevalence of research about integrating Virtual-Reality (VR) into
      various rehabilitations. Most of them have found that these VR-based rehabilitation can boost
      the motivation for participation, decrease the use of medical resources, and effectively
      contribute to the recovery of the patients. Inspired from these results, I think it might be
      interesting to integrate VR into the sarcopenia rehabilitation of elders.

      This research has combined existed VR games with progressive resistance exercise of the upper
      limbs and exercises for the function movement system (F.M.S) of the upper limbs, establishing
      a VR-based rehabilitation program designed for sarcopenia elders. The rehabilitation programs
      spans for 8 weeks, and is conducted at least twice a week for each subject. The research
      question of this research is: "What is the impact of Virtual Reality-based rehabilitation on
      upper limb sarcopenia patient?".

      The primary outcome of this research examines the change in muscle mass (measured by skeletal
      mass index, fat mass index and fat-free mass index), hand grip strength of the dominant hand
      and gait speed. The secondary outcome of this research examines the the change in range of
      motion of the upper limbs (shoulder flexion, shoulder external rotation, shoulder abduction,
      elbow flexion, elbow extension, elbow supination, elbow pronation, wrist flexion, wrist
      extension) and the functional ability of the upper limbs (measured by box and block test).

      Hypothesis:

        1. After two months of participating in the rehabilitation program, the primary outcomes
           (muscle mass, hand grip strength, and gait speed), show statistically significant
           increase.

        2. After two months of participating in the rehabilitation program, the secondary outcomes
           (change of range of motion of the upper limbs and functional ability of upper limbs)
           show statistically significant increase.

      Flow of the research:

        1. Sarcopenia patients are first selected from the daycare and nursing home of Chi-Shan
           Hospital.

        2. The first period of rehabilitation begins right after the selection and lasts for one
           month.

        3. The first evaluation begins after the first period of rehabilitation

        4. The second period of rehabilitation begins and lasts for one month.

        5. The second evaluation begins after the second period of rehabilitation.

      Apparatus in this study:

        1. Leap Motion Controller

        2. Oculus Rift headset (CV1)

        3. Oculus Sensors (a pair)

        4. (oculus) Touch Controllers

        5. Omron KARADA Scan Body Composition & Scale (HBF-701)

        6. JAMAR Hand Dynamometer

        7. MicroFET3 Dynamometer and ROM Evaluator

        8. Goniometer

        9. Box and Block Test Apparatus
allocation: N/A
intervention model: Single Group Assignment
intervention model description: elder residents in caring facilities, including nursing home and daycare center 15 participants in nursing home and 15 participants in daycare center
primary purpose: Prevention
masking: None (Open Label)
measure: Change of Hand-grip Strength of the Dominant Hand Between the Third Month and the Baseline
time frame: 3 months after the intervention of the virtual reality-based rehabilitation programs
description: The measurements of the HGS were determined by means of the JAMAR-Dynamometer. The forearm was held in neutral position and the wrist at a 0 to 30° extension. The instrument was held freely: neither the hand nor the forearm was allowed to rest on a surface. Three measurements were done and recorded as the average of the three measurements and the participants rested for 1 minute in between measurements.
The change was calculated by the data of the third month minus the baseline data.
measure: Change of Walking Speed Between the Third Month and the Baseline
time frame: 3 months after the intervention of the virtual reality-based rehabilitation programs
description: Timing starts after the patient starts walking and stops at the point when a patient reaches a distance of 6 meters. The gait speed in measured twice and the final measurement is the average of the two scores. The patient is allowed to rest for 10 minutes in between measurement.
The change was calculated by the data of the third month minus the baseline data.
measure: Change of Appendicular Skeletal Muscle Mass Between the Third Month and the Baseline
time frame: 3 months after the intervention of the virtual reality-based rehabilitation programs
description: Appendicular skeletal muscle mass (ASM) is deﬁned by the sum of the lean soft tissue mass of four limbs. Appendicular skeletal muscle mass index (ASMI) is defined as ASM (kg) divided by squared height (m).The body composition was measured via bio-electrical impedance analysis by Omron KARADA Scan Body Composition & Scale (HBF-701). A participant was considered to have low muscle mass if his or her ASMI was below -2 standard deviations of the reference defined in previous studies from Taiwan (6.76 kg/m2 for men and 5.28 kg/m2 for women). Participants with ASMI in the lowest 20% of the sex-specific distribution were considered to have low muscle mass, too. Increased of ASMI after virtual reality-based rehabilitation programs is considered to be better.
The change was calculated by the data of the third month minus the baseline data.
measure: Range of Motions in Dominant Upper Extremity
time frame: baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs
description: Use goniometry for range of motion measurement. The joints measured include shoulder, elbow, and wrist of the dominant side.
measure: Strength of Biceps Brachii and Triceps Brachii of the Dominant Upper Extremity
time frame: baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs
description: This research uses MicroFET3 to measure the the maximal voluntary isometric contraction of the biceps and triceps. Measurements are taken 2 times and the results are averaged. MicroFET3 is a electronic hand-held dynamometer that can measure muscle strength. The range of muscle testing of the device ranges from 0-150 lbs force.(Digital Dynamometer and Inclinometer | MicroFET®3) .
measure: Box and Block Test
time frame: baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs
description: The Box and Block Test (BBT) can measure the unilateral gross manual dexterity. The set up of the BBT test includes a wooden box with 150 wooden blocks inside. The wooden box is divided into two compartments. One filled with blocks, and the other is empty.During this test, the patient is seated upright in a chair and needs to transfer the wooden blocks, one by one, from one compartment to the other. The patient is scored based on the number of blocks he or she can transferred from one compartment to the other in 60 seconds.
arm group label: elderly with sarcopenia
arm group type: Experimental
description: Virtual reality-based rehabilitation programs
intervention type: Other
intervention name: Virtual reality-based rehabilitation programs
description: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer.
arm group label: elderly with sarcopenia
criteria: 
gender: All
minimum age: 60 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: Taiwan
citation: Ali S, Garcia JM. Sarcopenia, cachexia and aging: diagnosis, mechanisms and therapeutic options - a mini-review. Gerontology. 2014;60(4):294-305. doi: 10.1159/000356760. Epub 2014 Apr 8.
PMID: 24731978
citation: Frontera WR, Hughes VA, Fielding RA, Fiatarone MA, Evans WJ, Roubenoff R. Aging of skeletal muscle: a 12-yr longitudinal study. J Appl Physiol (1985). 2000 Apr;88(4):1321-6. doi: 10.1152/jappl.2000.88.4.1321.
PMID: 10749826
citation: Lexell J. Human aging, muscle mass, and fiber type composition. J Gerontol A Biol Sci Med Sci. 1995 Nov;50 Spec No:11-6. doi: 10.1093/gerona/50a.special_issue.11.
PMID: 7493202
citation: Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96. doi: 10.1046/j.1532-5415.2002.50216.x.
PMID: 12028177
citation: Janssen I, Shepard DS, Katzmarzyk PT, Roubenoff R. The healthcare costs of sarcopenia in the United States. J Am Geriatr Soc. 2004 Jan;52(1):80-5. doi: 10.1111/j.1532-5415.2004.52014.x.
PMID: 14687319
citation: Chen LK, Liu LK, Woo J, Assantachai P, Auyeung TW, Bahyah KS, Chou MY, Chen LY, Hsu PS, Krairit O, Lee JS, Lee WJ, Lee Y, Liang CK, Limpawattana P, Lin CS, Peng LN, Satake S, Suzuki T, Won CW, Wu CH, Wu SN, Zhang T, Zeng P, Akishita M, Arai H. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb;15(2):95-101. doi: 10.1016/j.jamda.2013.11.025.
PMID: 24461239
citation: Lo YC, Wahlqvist ML, Huang YC, Chuang SY, Wang CF, Lee MS. Medical costs of a low skeletal muscle mass are modulated by dietary diversity and physical activity in community-dwelling older Taiwanese: a longitudinal study. Int J Behav Nutr Phys Act. 2017 Mar 14;14(1):31. doi: 10.1186/s12966-017-0487-x.
PMID: 28288651
citation: Yarasheski KE, Pak-Loduca J, Hasten DL, Obert KA, Brown MB, Sinacore DR. Resistance exercise training increases mixed muscle protein synthesis rate in frail women and men >/=76 yr old. Am J Physiol. 1999 Jul;277(1):E118-25. doi: 10.1152/ajpendo.1999.277.1.E118.
PMID: 10409135
citation: Chen KM, Li CH, Chang YH, Huang HT, Cheng YY. An elastic band exercise program for older adults using wheelchairs in Taiwan nursing homes: a cluster randomized trial. Int J Nurs Stud. 2015 Jan;52(1):30-8. doi: 10.1016/j.ijnurstu.2014.06.005. Epub 2014 Jun 19.
PMID: 25037651
citation: Liu CJ, Latham NK. Progressive resistance strength training for improving physical function in older adults. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):CD002759. doi: 10.1002/14651858.CD002759.pub2.
PMID: 19588334
citation: Park DS, Lee DG, Lee K, Lee G. Effects of Virtual Reality Training using Xbox Kinect on Motor Function in Stroke Survivors: A Preliminary Study. J Stroke Cerebrovasc Dis. 2017 Oct;26(10):2313-2319. doi: 10.1016/j.jstrokecerebrovasdis.2017.05.019. Epub 2017 Jun 9.
PMID: 28606661
citation: Ilg W, Schatton C, Schicks J, Giese MA, Schols L, Synofzik M. Video game-based coordinative training improves ataxia in children with degenerative ataxia. Neurology. 2012 Nov 13;79(20):2056-60. doi: 10.1212/WNL.0b013e3182749e67. Epub 2012 Oct 31.
PMID: 23115212
citation: Garcia JA, Felix Navarro K, Schoene D, Smith ST, Pisan Y. Exergames for the elderly: towards an embedded Kinect-based clinical test of falls risk. Stud Health Technol Inform. 2012;178:51-7.
PMID: 22797019
citation: Bohannon RW. Test-retest reliability of the MicroFET 4 hand-grip dynamometer. Physiother Theory Pract. 2006 Sep;22(4):219-21. doi: 10.1080/09593980600822875.
PMID: 16920680
citation: Stark T, Walker B, Phillips JK, Fejer R, Beck R. Hand-held dynamometry correlation with the gold standard isokinetic dynamometry: a systematic review. PM R. 2011 May;3(5):472-9. doi: 10.1016/j.pmrj.2010.10.025.
PMID: 21570036
responsible party type: Principal Investigator
investigator affiliation: Cishan Hospital, Ministry of Health and Welfare
investigator full name: Sheng-Hui Tuan
investigator title: Attending Physician of Department of Rehabilitation
mesh term: Sarcopenia
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 