<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/NCT04414462</url>
  </required_header>
  <id_info>
    <org_study_id>REC/00743 Amina bukhari</org_study_id>
    <nct_id>NCT04414462</nct_id>
  </id_info>
  <brief_title>Comparison of Exergaming and Vestibular Training on Gaze Stability, Balance and Gait Performance of Older Adults.</brief_title>
  <official_title>Comparison of Exergaming and Vestibular Training on Gaze Stability, Balance and Gait Performance of Older Adults.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Riphah International University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Riphah International University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Exergames showed beneficial effects than conventional exercises for gaze stability, balance&#xD;
      and gait improvements in older individuals. Further studies should be conducted to explore&#xD;
      the benefits of exergames on older adults. This study aims to explore that exergaming has&#xD;
      more effects on gaze stability, balance and gait performance of older individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to a recent report by 2050, the global adult population between the age 65 and&#xD;
      above is expected to increase to 28%. A total of 12.13 million people in Pakistan are above&#xD;
      age of 60, which is expected to raise to 17.53 million by 2025. A high quality of life as&#xD;
      well as longevity is considered important in older adults.However, characteristics of aging&#xD;
      include a decrease in muscle strength, balance and decreased vestibular functions can lead to&#xD;
      falls and compromise good health in older adults.&#xD;
&#xD;
      Vestibular rehabilitation is an exercised based program intended to alleviate both primary&#xD;
      and secondary problems caused by vestibular disorders.The main focus of vestibular&#xD;
      rehabilitation is to use the existing vestibular system for gaze, postural stability and gait&#xD;
      by use of somatosensory and visual cues. Depending on the vestibular disorders three main&#xD;
      types of exercises are used. Habituation Gaze stability exercises ,Balance training.&#xD;
      Habituation exercises are indicated for patients who complain of dizziness during quick head&#xD;
      movements and when they change position like when they bend over or look up to reach above&#xD;
      their head. The goal of habituation exercise is to reduce the dizziness through repeated&#xD;
      exposure to specific movements or visual stimuli that provoke patient's dizziness.&#xD;
&#xD;
      Gaze stability exercises include eyeball movement, saccadic eye movement, pursuit eye&#xD;
      movement, vergence eye movement, vestibular-ocular reflex exercise. These exercises improve&#xD;
      the static balance control thus improves postural control required for vestibular function&#xD;
      and can be mediated by VSR improvements. These exercises are useful in bilateral vestibular&#xD;
      hypofunction. Balance training are used to improve standing, bending, reaching and&#xD;
      performance of dual tasks on even and uneven surfaces. These exercises proved to be effective&#xD;
      in making individuals do activities of daily livings and prevents the risks of falls.&#xD;
&#xD;
      Computer based technology is becoming popular in rehabilitation. It stimulates learning in&#xD;
      real-life environment and provides a 3-dimensional sensory feedback. A computer-generated&#xD;
      technology allows the user to interact with a virtual world and to make correction during&#xD;
      performing an exercise task. In particular, previous studies have suggested that new&#xD;
      technology, such as the Wii Fit Board (WFB) can be used for balance training using virtual&#xD;
      reality These games have showed repeated good results in vestibular rehabilitation of&#xD;
      elderly.Virtual reality enables the individual to be physically active and provides a&#xD;
      pleasant and motivating way of training in these individuals.&#xD;
&#xD;
      There are literature for the safe and effective use of exergaming in improving gaze&#xD;
      stability, balance and postural control in older individuals Jaap Swanenburg et al concluded&#xD;
      that exergaming is effective in improving gaze stability, balance and postural control in&#xD;
      older adults .Lynne M Taylor showed that active video games proved to be effective in&#xD;
      improving balance and gait in older individuals .J Hashim concluded that Exergames improved&#xD;
      dynamic balance in older adults when compared with conventional exercises.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">October 31, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Timed Up and Go test (TUG)</measure>
    <time_frame>Change from Baseline balance to 6th Weeks</time_frame>
    <description>TUG is a test used to assess a person's mobility. TUG measured the time required for an individual to stand up from a chair with armrests, walk 3 m, turn, walk back to the chair, and sit down. Normal healthy elderly usually completes the task in ten seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dynamic Visual Acuity</measure>
    <time_frame>Change from Baseline vestibular ocular reflex to 6th Week</time_frame>
    <description>It provides an objective and instrumented way of assessing Vestibulo-ocular reflex (VOR)function in response to rotational and functional head movement stimuli. The DVA testing system consisted of a personal computer with a monitor and a velocity sensor which is fixed on a headset to the participant's head. Minimum acceptable head testing velocity was 150◦/s.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dynamic Gait Index</measure>
    <time_frame>Change from Baseline gait to 6th Week</time_frame>
    <description>Dynamic gait index is used to assess gait, balance and fall risk. It is a valuable clinical tool for evaluating dynamic balance in community dwelling older adults. Total score is 24, a score &lt; 19/24 is predictive of falls risk in community dwelling elderly</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Force Platform</measure>
    <time_frame>Change from Baseline postural variation to 6th Week</time_frame>
    <description>It provides a quantitative way to measure postural control and analysis of various aspects of balance.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Older Adults</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group I will receive following exergaming training: heading, tightrope tension,snowboard slalom and table tilt game</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group II will receive Habituation,wobble board exercises,double leg,single leg and tandem stance training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>exergaming training</intervention_name>
    <description>HEADING: For 5 mins a day,3 days a week in first 3 weeks (beginner level game) and for 10 mins a day, 3 days a week for 3 weeks. (advanced level game)&#xD;
TIGHTROPE TENSION: For 5 mins a day,3 days a week in first 3 weeks (beginner level game) and for 10 mins a day, 3 days a week for 3 weeks. (advanced level game)&#xD;
SNOWBOARD SLALOM: For 5 mins a day,3 days a week in first 3 weeks (beginner level game) and for 10 mins a day, 3 days a week for 3 weeks. (advanced level game)&#xD;
TABLE TILT: For 5 mins a day,3 days a week in first 3 weeks (beginner level game) and for 10 mins a day, 3 days a week for 3 weeks. (advanced level game)</description>
    <arm_group_label>Group I</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>training - Group II</intervention_name>
    <description>Wobble board for 4 mins a day,3 days a week for first 3 weeks and for 8 mins a day,3 days a week for 3 weeks.&#xD;
Habituation exercises for 4 mins a day,3 days a week for first 3 weeks and for 8 mins a day,3 days a week for 3 weeks.&#xD;
Double leg stance with eyes open and eyes closed on firm surface and on foam for 4 mins a day,3 days a week for first 3 weeks and for 8 mins a day,3 days a week for 3 weeks.&#xD;
Single leg stance with eyes open and eyes open on firm surface and on foam for 4 mins a day,3 days a week for first 3 weeks and for 8 mins a day,3 days a week for 3 weeks.&#xD;
Tandem walk stance with eyes open and eyes closed on firm surface and on foam for 4 mins a day,3 days a week for first 3 weeks and for 8 mins a day,3 days a week for 3 weeks.</description>
    <arm_group_label>Group II</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A score of 21 and above on berg balance scale.&#xD;
&#xD;
          -  A minimum head velocity of 150◦/s on dynamic visual acuity test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute Musculoskeletal pain&#xD;
&#xD;
          -  Uncontrollable cardiovascular disease (e.g. High blood pressure, Uncontrolled sugar)&#xD;
&#xD;
          -  Weakness from known neurological problems (Parkinson's, stroke, multiple sclerosis)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Misbah Ghous, MSNMPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Riphah International University Islamabad</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pakistan General Railway Hospital</name>
      <address>
        <city>Rawalpindi</city>
        <state>Punjab</state>
        <zip>46000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <reference>
    <citation>Tomita Y, Arima K, Tsujimoto R, Kawashiri SY, Nishimura T, Mizukami S, Okabe T, Tanaka N, Honda Y, Izutsu K, Yamamoto N, Ohmachi I, Kanagae M, Abe Y, Aoyagi K. Prevalence of fear of falling and associated factors among Japanese community-dwelling older adults. Medicine (Baltimore). 2018 Jan;97(4):e9721. doi: 10.1097/MD.0000000000009721.</citation>
    <PMID>29369207</PMID>
  </reference>
  <reference>
    <citation>Siddiqi FA, Masood T, Osama M, Azim ME, Babur MN. Common balance measures and fall risk scores among older adults in Pakistan: Normative values and correlation. J Pak Med Assoc. 2019 Feb;69(2):246-249.</citation>
    <PMID>30804593</PMID>
  </reference>
  <reference>
    <citation>Lee Y, Choi W, Lee K, Song C, Lee S. Virtual Reality Training With Three-Dimensional Video Games Improves Postural Balance and Lower Extremity Strength in Community-Dwelling Older Adults. J Aging Phys Act. 2017 Oct 1;25(4):621-627. doi: 10.1123/japa.2015-0271. Epub 2017 Sep 19.</citation>
    <PMID>28290746</PMID>
  </reference>
  <reference>
    <citation>Hall CD, Herdman SJ, Whitney SL, Cass SP, Clendaniel RA, Fife TD, Furman JM, Getchius TS, Goebel JA, Shepard NT, Woodhouse SN. Treatment for Vestibular Disorders: How Does Your Physical Therapist Treat Dizziness Related to Vestibular Problems? J Neurol Phys Ther. 2016 Apr;40(2):156. doi: 10.1097/01.NPT.0000481898.55592.6e. No abstract available.</citation>
    <PMID>26934418</PMID>
  </reference>
  <reference>
    <citation>Swanenburg J, Babler E, Adelsberger R, Straumann D, de Bruin ED. Patients with chronic peripheral vestibular hypofunction compared to healthy subjects exhibit differences in gaze and gait behaviour when walking on stairs and ramps. PLoS One. 2017 Dec 18;12(12):e0189037. doi: 10.1371/journal.pone.0189037. eCollection 2017.</citation>
    <PMID>29253883</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>March 6, 2021</last_update_submitted>
  <last_update_submitted_qc>March 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exergaming</keyword>
  <keyword>vestibular training</keyword>
  <keyword>gaze stability</keyword>
  <keyword>Balance</keyword>
  <keyword>Gait</keyword>
  <keyword>older adults</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04414462
org study id: REC/00743 Amina bukhari
nct id: NCT04414462
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Exergames showed beneficial effects than conventional exercises for gaze stability, balance
      and gait improvements in older individuals. Further studies should be conducted to explore
      the benefits of exergames on older adults. This study aims to explore that exergaming has
      more effects on gaze stability, balance and gait performance of older individuals.
According to a recent report by 2050, the global adult population between the age 65 and
      above is expected to increase to 28%. A total of 12.13 million people in Pakistan are above
      age of 60, which is expected to raise to 17.53 million by 2025. A high quality of life as
      well as longevity is considered important in older adults.However, characteristics of aging
      include a decrease in muscle strength, balance and decreased vestibular functions can lead to
      falls and compromise good health in older adults.

      Vestibular rehabilitation is an exercised based program intended to alleviate both primary
      and secondary problems caused by vestibular disorders.The main focus of vestibular
      rehabilitation is to use the existing vestibular system for gaze, postural stability and gait
      by use of somatosensory and visual cues. Depending on the vestibular disorders three main
      types of exercises are used. Habituation Gaze stability exercises ,Balance training.
      Habituation exercises are indicated for patients who complain of dizziness during quick head
      movements and when they change position like when they bend over or look up to reach above
      their head. The goal of habituation exercise is to reduce the dizziness through repeated
      exposure to specific movements or visual stimuli that provoke patient's dizziness.

      Gaze stability exercises include eyeball movement, saccadic eye movement, pursuit eye
      movement, vergence eye movement, vestibular-ocular reflex exercise. These exercises improve
      the static balance control thus improves postural control required for vestibular function
      and can be mediated by VSR improvements. These exercises are useful in bilateral vestibular
      hypofunction. Balance training are used to improve standing, bending, reaching and
      performance of dual tasks on even and uneven surfaces. These exercises proved to be effective
      in making individuals do activities of daily livings and prevents the risks of falls.

      Computer based technology is becoming popular in rehabilitation. It stimulates learning in
      real-life environment and provides a 3-dimensional sensory feedback. A computer-generated
      technology allows the user to interact with a virtual world and to make correction during
      performing an exercise task. In particular, previous studies have suggested that new
      technology, such as the Wii Fit Board (WFB) can be used for balance training using virtual
      reality These games have showed repeated good results in vestibular rehabilitation of
      elderly.Virtual reality enables the individual to be physically active and provides a
      pleasant and motivating way of training in these individuals.

      There are literature for the safe and effective use of exergaming in improving gaze
      stability, balance and postural control in older individuals Jaap Swanenburg et al concluded
      that exergaming is effective in improving gaze stability, balance and postural control in
      older adults .Lynne M Taylor showed that active video games proved to be effective in
      improving balance and gait in older individuals .J Hashim concluded that Exergames improved
      dynamic balance in older adults when compared with conventional exercises.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Timed Up and Go test (TUG)
time frame: Change from Baseline balance to 6th Weeks
description: TUG is a test used to assess a person's mobility. TUG measured the time required for an individual to stand up from a chair with armrests, walk 3 m, turn, walk back to the chair, and sit down. Normal healthy elderly usually completes the task in ten seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more.
measure: Dynamic Visual Acuity
time frame: Change from Baseline vestibular ocular reflex to 6th Week
description: It provides an objective and instrumented way of assessing Vestibulo-ocular reflex (VOR)function in response to rotational and functional head movement stimuli. The DVA testing system consisted of a personal computer with a monitor and a velocity sensor which is fixed on a headset to the participant's head. Minimum acceptable head testing velocity was 150◦/s.
measure: Dynamic Gait Index
time frame: Change from Baseline gait to 6th Week
description: Dynamic gait index is used to assess gait, balance and fall risk. It is a valuable clinical tool for evaluating dynamic balance in community dwelling older adults. Total score is 24, a score < 19/24 is predictive of falls risk in community dwelling elderly
measure: Force Platform
time frame: Change from Baseline postural variation to 6th Week
description: It provides a quantitative way to measure postural control and analysis of various aspects of balance.
arm group label: Group I
arm group type: Experimental
description: Group I will receive following exergaming training: heading, tightrope tension,snowboard slalom and table tilt game
arm group label: Group II
arm group type: Active Comparator
description: Group II will receive Habituation,wobble board exercises,double leg,single leg and tandem stance training.
intervention type: Other
intervention name: exergaming training
description: HEADING: For 5 mins a day,3 days a week in first 3 weeks (beginner level game) and for 10 mins a day, 3 days a week for 3 weeks. (advanced level game)
TIGHTROPE TENSION: For 5 mins a day,3 days a week in first 3 weeks (beginner level game) and for 10 mins a day, 3 days a week for 3 weeks. (advanced level game)
SNOWBOARD SLALOM: For 5 mins a day,3 days a week in first 3 weeks (beginner level game) and for 10 mins a day, 3 days a week for 3 weeks. (advanced level game)
TABLE TILT: For 5 mins a day,3 days a week in first 3 weeks (beginner level game) and for 10 mins a day, 3 days a week for 3 weeks. (advanced level game)
arm group label: Group I
intervention type: Other
intervention name: training - Group II
description: Wobble board for 4 mins a day,3 days a week for first 3 weeks and for 8 mins a day,3 days a week for 3 weeks.
Habituation exercises for 4 mins a day,3 days a week for first 3 weeks and for 8 mins a day,3 days a week for 3 weeks.
Double leg stance with eyes open and eyes closed on firm surface and on foam for 4 mins a day,3 days a week for first 3 weeks and for 8 mins a day,3 days a week for 3 weeks.
Single leg stance with eyes open and eyes open on firm surface and on foam for 4 mins a day,3 days a week for first 3 weeks and for 8 mins a day,3 days a week for 3 weeks.
Tandem walk stance with eyes open and eyes closed on firm surface and on foam for 4 mins a day,3 days a week for first 3 weeks and for 8 mins a day,3 days a week for 3 weeks.
arm group label: Group II
criteria: 
gender: All
minimum age: 60 Years
maximum age: 75 Years
healthy volunteers: No
last name: Misbah Ghous, MSNMPT
role: Principal Investigator
affiliation: Riphah International University Islamabad
facility: 
country: Pakistan
citation: Tomita Y, Arima K, Tsujimoto R, Kawashiri SY, Nishimura T, Mizukami S, Okabe T, Tanaka N, Honda Y, Izutsu K, Yamamoto N, Ohmachi I, Kanagae M, Abe Y, Aoyagi K. Prevalence of fear of falling and associated factors among Japanese community-dwelling older adults. Medicine (Baltimore). 2018 Jan;97(4):e9721. doi: 10.1097/MD.0000000000009721.
PMID: 29369207
citation: Siddiqi FA, Masood T, Osama M, Azim ME, Babur MN. Common balance measures and fall risk scores among older adults in Pakistan: Normative values and correlation. J Pak Med Assoc. 2019 Feb;69(2):246-249.
PMID: 30804593
citation: Lee Y, Choi W, Lee K, Song C, Lee S. Virtual Reality Training With Three-Dimensional Video Games Improves Postural Balance and Lower Extremity Strength in Community-Dwelling Older Adults. J Aging Phys Act. 2017 Oct 1;25(4):621-627. doi: 10.1123/japa.2015-0271. Epub 2017 Sep 19.
PMID: 28290746
citation: Hall CD, Herdman SJ, Whitney SL, Cass SP, Clendaniel RA, Fife TD, Furman JM, Getchius TS, Goebel JA, Shepard NT, Woodhouse SN. Treatment for Vestibular Disorders: How Does Your Physical Therapist Treat Dizziness Related to Vestibular Problems? J Neurol Phys Ther. 2016 Apr;40(2):156. doi: 10.1097/01.NPT.0000481898.55592.6e. No abstract available.
PMID: 26934418
citation: Swanenburg J, Babler E, Adelsberger R, Straumann D, de Bruin ED. Patients with chronic peripheral vestibular hypofunction compared to healthy subjects exhibit differences in gaze and gait behaviour when walking on stairs and ramps. PLoS One. 2017 Dec 18;12(12):e0189037. doi: 10.1371/journal.pone.0189037. eCollection 2017.
PMID: 29253883
responsible party type: Sponsor
sharing ipd: No