xml: <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/NCT06026137</url>
    </required_header>
    <id_info>
      <org_study_id>JVT002</org_study_id>
      <nct_id>NCT06026137</nct_id>
    </id_info>
    <brief_title>Use of the Efisiotrack System for Monitoring Patients With Shoulder Orthopedic Injuries</brief_title>
    <official_title>Use of the Efisiotrack System for Monitoring Prescribed Therapeutic Exercises in Patients With Shoulder Orthopedic Injuries in a Hospital Setting: a Pilot Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universidad Miguel Hernandez de Elche</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Hospital General Universitario Elche</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Universidad Miguel Hernandez de Elche</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>
        To evaluate the effect on clinical variables of monitoring exercises prescribed for shoulder&#xD;
        injury rehabilitation with the eFisioTrack platform in patients of the Rehabilitation Service&#xD;
        at University Hospital of Elche.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients who be referred to the rehabilitation service of the University Hospital of Elche&#xD;
        (Spain) for physiotherapy treatment (manual therapy, exercise, stretching, and&#xD;
        electrotherapy) after suffering orthopedic injury or surgery in the shoulder joint complex&#xD;
        will be considered for enrollment in the study.&#xD;
  &#xD;
        Patients will performed the prescribed physical therapy treatment, at least three times per&#xD;
        week in sessions of 45 minutes in the hospital setting (application of manual therapy and&#xD;
        physical modalities as ultrasound, heat/cold, laser, magnetic field therapy) together with&#xD;
        completion of the exercise program for functional recovery of the upper extremity (exercises&#xD;
        for muscle strength, scapular stability, joint mobility, and proprioception).&#xD;
  &#xD;
        Following baseline examination, patients will be randomly assigned to either&#xD;
        physiotherapist-supervised exercise (control group) or monitoring by the eFisioTrack system&#xD;
        (experimental group) to perform active exercises as part of their shoulder rehabilitation.&#xD;
        These will be performed independently by each patient in a hospital room without supervision&#xD;
        by the physiotherapist.&#xD;
  &#xD;
        The following patient-reported outcome measures will be used to assess participants' shoulder&#xD;
        pain and function: the Disabilities of Arm, Shoulder and Hand (DASH) score and the&#xD;
        Constant-Murley (CM) score.&#xD;
  &#xD;
        All participants will be assessed at baseline on their first visit to the physical therapy&#xD;
        area and at one-month follow-up.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 29, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Actual">August 30, 2023</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>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Disabilities of Arm, Shoulder and Hand (DASH) score</measure>
      <time_frame>At baseline and at one month follow-up.</time_frame>
      <description>DASH - Measures symptoms and degree of function related to a disorder in the upper extremity. The DASH Outcome Measure is scored in two components: the disability/symptom section (30 items, scored 1-5) and the optional high performance Sport/Music or Work section (4 items, scored 1-5). At least 27 of the 30 items must be completed for a score to be calculated. The assigned values for all completed responses are simply summed and averaged, producing a score out of five. This value is then transformed to a score out of 100 by subtracting one and multiplying by 25. This transformation is done to make the score easier to compare to other measures scaled on a 0-100 scale. A higher score indicates greater disability.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Constant-Murley (CM) score.</measure>
      <time_frame>At baseline and at one month follow-up.</time_frame>
      <description>CMS - specific instrument for assessing the shoulder joint: pain; ability to perform daily activities; mobility and strength. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Shoulder Injuries</condition>
    <arm_group>
      <arm_group_label>eFisioTrack Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Use of the eFisioTrack platform in the experimental group to perform active exercises as part of their shoulder rehabilitation. These will. bee performed independently by each patient in a hospital room, using the efisioTrack system without supervision by the physiotherapist.&#xD;
  The subjects will be previously instructed in the use of the system in two 20-minute sessions. The type of exercise and its parameters will be chosen and progressed considering the functional status of the patient and being similar to those executed under the physiotherapist's supervision.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Excercises Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients who performed the exercise program supervised by the physical physiotherapist in a hospital room.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>eFisioTrack Group</intervention_name>
      <description>Application of manual therapy and physical modalities together with completion of the exercise program for functional recovery of the upper extremity using the efisioTrack system without supervision by the physiotherapist.</description>
      <arm_group_label>eFisioTrack Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Excercises Group</intervention_name>
      <description>Application of manual therapy and physical modalities together with completion of the exercise program for functional recovery of the upper extremity supervised by the physical physiotherapist in a hospital room.</description>
      <arm_group_label>Excercises Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Be at least 18 years old and be able to read and understand Spanish.&#xD;
  &#xD;
            -  Suffer a traumatic or degenerative shoulder injury, with or without surgical&#xD;
               treatment.&#xD;
  &#xD;
            -  Have a prescription for rehabilitative physical therapy that includes active&#xD;
               exercises.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -Had a concomitant injury on an upper extremity or the cervical spine at the time of&#xD;
          participation or sequelae of previous injuries in the area.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jorge Roses Conde, Ph</last_name>
      <role>Study Director</role>
      <affiliation>Hospital Generalof Elche</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jose-Vicente Toledo-Marhuenda, PhD.</last_name>
      <phone>965 91 92 60</phone>
      <phone_ext>9260</phone_ext>
      <email>josetoledo@umh.es</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sergio Hernández-Sánchez, PhD</last_name>
      <phone>965 91 25 48</phone>
      <phone_ext>2548</phone_ext>
      <email>sehesa@umh.es</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hospital General of Elche</name>
        <address>
          <city>Elche</city>
          <state>Alicante</state>
          <zip>03203</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jorge Roses Conde, Ph</last_name>
        <phone>966 61 69 00</phone>
        <phone_ext>6900</phone_ext>
        <email>jroses@umh.es</email>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <reference>
      <citation>Holmgren T, Bjornsson Hallgren H, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. BMJ. 2012 Feb 20;344:e787. doi: 10.1136/bmj.e787.</citation>
      <PMID>22349588</PMID>
    </reference>
    <reference>
      <citation>Baroni MP, Jacob MFA, Rios WR, Fandim JV, Fernandes LG, Chaves PI, Fioratti I, Saragiotto BT. The state of the art in telerehabilitation for musculoskeletal conditions. Arch Physiother. 2023 Jan 4;13(1):1. doi: 10.1186/s40945-022-00155-0.</citation>
      <PMID>36597130</PMID>
    </reference>
    <reference>
      <citation>Carbonaro N, Lucchesi I, Lorusssi F, Tognetti A. Tele-monitoring and tele-rehabilitation of the shoulder muscular-skeletal diseases through wearable systems. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:4410-4413. doi: 10.1109/EMBC.2018.8513371.</citation>
      <PMID>30441330</PMID>
    </reference>
    <reference>
      <citation>Hervas MT, Navarro Collado MJ, Peiro S, Rodrigo Perez JL, Lopez Mateu P, Martinez Tello I. [Spanish version of the DASH questionnaire. Cross-cultural adaptation, reliability, validity and responsiveness]. Med Clin (Barc). 2006 Sep 30;127(12):441-7. doi: 10.1157/13093053. Spanish.</citation>
      <PMID>17040628</PMID>
    </reference>
    <results_reference>
      <citation>Lucas J, van Doorn P, Hegedus E, Lewis J, van der Windt D. A systematic review of the global prevalence and incidence of shoulder pain. BMC Musculoskelet Disord. 2022 Dec 8;23(1):1073. doi: 10.1186/s12891-022-05973-8.</citation>
      <PMID>36476476</PMID>
    </results_reference>
    <results_reference>
      <citation>Greenberg DL. Evaluation and treatment of shoulder pain. Med Clin North Am. 2014 May;98(3):487-504. doi: 10.1016/j.mcna.2014.01.016. Epub 2014 Mar 22.</citation>
      <PMID>24758957</PMID>
    </results_reference>
    <results_reference>
      <citation>Page MJ, Green S, McBain B, Surace SJ, Deitch J, Lyttle N, Mrocki MA, Buchbinder R. Manual therapy and exercise for rotator cuff disease. Cochrane Database Syst Rev. 2016 Jun 10;2016(6):CD012224. doi: 10.1002/14651858.CD012224.</citation>
      <PMID>27283590</PMID>
    </results_reference>
    <results_reference>
      <citation>Kromer TO, Tautenhahn UG, de Bie RA, Staal JB, Bastiaenen CH. Effects of physiotherapy in patients with shoulder impingement syndrome: a systematic review of the literature. J Rehabil Med. 2009 Nov;41(11):870-80. doi: 10.2340/16501977-0453.</citation>
      <PMID>19841837</PMID>
    </results_reference>
    <results_reference>
      <citation>Babatunde OO, Ensor J, Littlewood C, Chesterton L, Jordan JL, Corp N, Wynne-Jones G, Roddy E, Foster NE, van der Windt DA. Comparative effectiveness of treatment options for subacromial shoulder conditions: a systematic review and network meta-analysis. Ther Adv Musculoskelet Dis. 2021 Sep 9;13:1759720X211037530. doi: 10.1177/1759720X211037530. eCollection 2021.</citation>
      <PMID>34527083</PMID>
    </results_reference>
    <results_reference>
      <citation>Paraskevopoulos E, Plakoutsis G, Chronopoulos E, Maria P. Effectiveness of Combined Program of Manual Therapy and Exercise Vs Exercise Only in Patients With Rotator Cuff-related Shoulder Pain: A Systematic Review and Meta-analysis. Sports Health. 2023 Sep-Oct;15(5):727-735. doi: 10.1177/19417381221136104. Epub 2022 Dec 14.</citation>
      <PMID>36517977</PMID>
    </results_reference>
    <results_reference>
      <citation>Burns D, Boyer P, Razmjou H, Richards R, Whyne C. Adherence Patterns and Dose Response of Physiotherapy for Rotator Cuff Pathology: Longitudinal Cohort Study. JMIR Rehabil Assist Technol. 2021 Mar 11;8(1):e21374. doi: 10.2196/21374.</citation>
      <PMID>33704076</PMID>
    </results_reference>
    <results_reference>
      <citation>Eriksson L, Lindstrom B, Ekenberg L. Patients' experiences of telerehabilitation at home after shoulder joint replacement. J Telemed Telecare. 2011;17(1):25-30. doi: 10.1258/jtt.2010.100317. Epub 2010 Nov 12.</citation>
      <PMID>21075802</PMID>
    </results_reference>
    <results_reference>
      <citation>Carnevale A, Longo UG, Schena E, Massaroni C, Lo Presti D, Berton A, Candela V, Denaro V. Wearable systems for shoulder kinematics assessment: a systematic review. BMC Musculoskelet Disord. 2019 Nov 15;20(1):546. doi: 10.1186/s12891-019-2930-4.</citation>
      <PMID>31731893</PMID>
    </results_reference>
    <results_reference>
      <citation>Sliepen M, Lipperts M, Tjur M, Mechlenburg I. Use of accelerometer-based activity monitoring in orthopaedics: benefits, impact and practical considerations. EFORT Open Rev. 2020 Jan 28;4(12):678-685. doi: 10.1302/2058-5241.4.180041. eCollection 2019 Dec.</citation>
      <PMID>32010456</PMID>
    </results_reference>
    <results_reference>
      <citation>Rizzo JR, Thai P, Li EJ, Tung T, Hudson TE, Herrera J, Raghavan P. Structured Wii protocol for rehabilitation of shoulder impingement syndrome: A pilot study. Ann Phys Rehabil Med. 2017 Nov;60(6):363-370. doi: 10.1016/j.rehab.2016.10.004. Epub 2017 Mar 15.</citation>
      <PMID>28330586</PMID>
    </results_reference>
    <results_reference>
      <citation>Anwar N, Karimi H, Ahmad A, Gilani SA, Khalid K, Aslam AS, Hanif A. Virtual Reality Training Using Nintendo Wii Games for Patients With Stroke: Randomized Controlled Trial. JMIR Serious Games. 2022 Jun 13;10(2):e29830. doi: 10.2196/29830.</citation>
      <PMID>35699989</PMID>
    </results_reference>
    <results_reference>
      <citation>Adie K, Schofield C, Berrow M, Wingham J, Humfryes J, Pritchard C, James M, Allison R. Does the use of Nintendo Wii SportsTM improve arm function? Trial of WiiTM in Stroke: a randomized controlled trial and economics analysis. Clin Rehabil. 2017 Feb;31(2):173-185. doi: 10.1177/0269215516637893. Epub 2016 Jul 10.</citation>
      <PMID>26975313</PMID>
    </results_reference>
    <results_reference>
      <citation>Ruiz-Fernandez D, Marin-Alonso O, Soriano-Paya A, Garcia-Perez JD. eFisioTrack: a telerehabilitation environment based on motion recognition using accelerometry. ScientificWorldJournal. 2014 Jan 12;2014:495391. doi: 10.1155/2014/495391. eCollection 2014.</citation>
      <PMID>24526898</PMID>
    </results_reference>
    <results_reference>
      <citation>Tate AR, McClure PW, Young IA, Salvatori R, Michener LA. Comprehensive impairment-based exercise and manual therapy intervention for patients with subacromial impingement syndrome: a case series. J Orthop Sports Phys Ther. 2010 Aug;40(8):474-93. doi: 10.2519/jospt.2010.3223.</citation>
      <PMID>20710088</PMID>
    </results_reference>
    <results_reference>
      <citation>Franchignoni F, Vercelli S, Giordano A, Sartorio F, Bravini E, Ferriero G. Minimal clinically important difference of the disabilities of the arm, shoulder and hand outcome measure (DASH) and its shortened version (QuickDASH). J Orthop Sports Phys Ther. 2014 Jan;44(1):30-9. doi: 10.2519/jospt.2014.4893. Epub 2013 Oct 30.</citation>
      <PMID>24175606</PMID>
    </results_reference>
    <results_reference>
      <citation>Roy JS, MacDermid JC, Woodhouse LJ. A systematic review of the psychometric properties of the Constant-Murley score. J Shoulder Elbow Surg. 2010 Jan;19(1):157-64. doi: 10.1016/j.jse.2009.04.008.</citation>
      <PMID>19559630</PMID>
    </results_reference>
    <results_reference>
      <citation>Kitis A, Celik E, Aslan UB, Zencir M. DASH questionnaire for the analysis of musculoskeletal symptoms in industry workers: a validity and reliability study. Appl Ergon. 2009 Mar;40(2):251-5. doi: 10.1016/j.apergo.2008.04.005. Epub 2008 Jun 16.</citation>
      <PMID>18555973</PMID>
    </results_reference>
    <results_reference>
      <citation>Pastora-Bernal JM, Martin-Valero R, Baron-Lopez FJ, Moyano NG, Estebanez-Perez MJ. Telerehabilitation after arthroscopic subacromial decompression is effective and not inferior to standard practice: Preliminary results. J Telemed Telecare. 2018 Jul;24(6):428-433. doi: 10.1177/1357633X17706583. Epub 2017 Apr 27.</citation>
      <PMID>28449618</PMID>
    </results_reference>
    <results_reference>
      <citation>Correia FD, Molinos M, Luis S, Carvalho D, Carvalho C, Costa P, Seabra R, Francisco G, Bento V, Lains J. Digitally Assisted Versus Conventional Home-Based Rehabilitation After Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Mar 1;101(3):237-249. doi: 10.1097/PHM.0000000000001780.</citation>
      <PMID>33935152</PMID>
    </results_reference>
    <results_reference>
      <citation>Grassi FA, Tajana MS. The normalization of data in the Constant-Murley score for the shoulder. A study conducted on 563 healthy subjects. Chir Organi Mov. 2003 Jan-Mar;88(1):65-73. English, Italian.</citation>
      <PMID>14584318</PMID>
    </results_reference>
    <results_reference>
      <citation>Kachingwe AF, Phillips B, Sletten E, Plunkett SW. Comparison of manual therapy techniques with therapeutic exercise in the treatment of shoulder impingement: a randomized controlled pilot clinical trial. J Man Manip Ther. 2008;16(4):238-47. doi: 10.1179/106698108790818314.</citation>
      <PMID>19771196</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universidad Miguel Hernandez de Elche</investigator_affiliation>
      <investigator_full_name>JOSE VICENTE TOLEDO MARHUENDA</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>rehabilitation</keyword>
    <keyword>shoulder injury</keyword>
    <keyword>monitoring device</keyword>
    <keyword>adherence</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Wounds and Injuries</mesh_term>
      <mesh_term>Shoulder Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>July 17, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT06026137/Prot_SAP_ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06026137
  org study id: JVT002
  nct id: NCT06026137
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the effect on clinical variables of monitoring exercises prescribed for shoulder
        injury rehabilitation with the eFisioTrack platform in patients of the Rehabilitation Service
        at University Hospital of Elche.
  Patients who be referred to the rehabilitation service of the University Hospital of Elche
        (Spain) for physiotherapy treatment (manual therapy, exercise, stretching, and
        electrotherapy) after suffering orthopedic injury or surgery in the shoulder joint complex
        will be considered for enrollment in the study.
  
        Patients will performed the prescribed physical therapy treatment, at least three times per
        week in sessions of 45 minutes in the hospital setting (application of manual therapy and
        physical modalities as ultrasound, heat/cold, laser, magnetic field therapy) together with
        completion of the exercise program for functional recovery of the upper extremity (exercises
        for muscle strength, scapular stability, joint mobility, and proprioception).
  
        Following baseline examination, patients will be randomly assigned to either
        physiotherapist-supervised exercise (control group) or monitoring by the eFisioTrack system
        (experimental group) to perform active exercises as part of their shoulder rehabilitation.
        These will be performed independently by each patient in a hospital room without supervision
        by the physiotherapist.
  
        The following patient-reported outcome measures will be used to assess participants' shoulder
        pain and function: the Disabilities of Arm, Shoulder and Hand (DASH) score and the
        Constant-Murley (CM) score.
  
        All participants will be assessed at baseline on their first visit to the physical therapy
        area and at one-month follow-up.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: Disabilities of Arm, Shoulder and Hand (DASH) score
  time frame: At baseline and at one month follow-up.
  description: DASH - Measures symptoms and degree of function related to a disorder in the upper extremity. The DASH Outcome Measure is scored in two components: the disability/symptom section (30 items, scored 1-5) and the optional high performance Sport/Music or Work section (4 items, scored 1-5). At least 27 of the 30 items must be completed for a score to be calculated. The assigned values for all completed responses are simply summed and averaged, producing a score out of five. This value is then transformed to a score out of 100 by subtracting one and multiplying by 25. This transformation is done to make the score easier to compare to other measures scaled on a 0-100 scale. A higher score indicates greater disability.
  measure: Constant-Murley (CM) score.
  time frame: At baseline and at one month follow-up.
  description: CMS - specific instrument for assessing the shoulder joint: pain; ability to perform daily activities; mobility and strength. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.
  arm group label: eFisioTrack Group
  arm group type: Experimental
  description: Use of the eFisioTrack platform in the experimental group to perform active exercises as part of their shoulder rehabilitation. These will. bee performed independently by each patient in a hospital room, using the efisioTrack system without supervision by the physiotherapist.
  The subjects will be previously instructed in the use of the system in two 20-minute sessions. The type of exercise and its parameters will be chosen and progressed considering the functional status of the patient and being similar to those executed under the physiotherapist's supervision.
  arm group label: Excercises Group
  arm group type: Active Comparator
  description: Patients who performed the exercise program supervised by the physical physiotherapist in a hospital room.
  intervention type: Procedure
  intervention name: eFisioTrack Group
  description: Application of manual therapy and physical modalities together with completion of the exercise program for functional recovery of the upper extremity using the efisioTrack system without supervision by the physiotherapist.
  arm group label: eFisioTrack Group
  intervention type: Procedure
  intervention name: Excercises Group
  description: Application of manual therapy and physical modalities together with completion of the exercise program for functional recovery of the upper extremity supervised by the physical physiotherapist in a hospital room.
  arm group label: Excercises Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jorge Roses Conde, Ph
  role: Study Director
  affiliation: Hospital Generalof Elche
  last name: Jose-Vicente Toledo-Marhuenda, PhD.
  phone: 965 91 92 60
  phone ext: 9260
  email: josetoledo@umh.es
  last name: Sergio Hernández-Sánchez, PhD
  phone: 965 91 25 48
  phone ext: 2548
  email: sehesa@umh.es
  facility: 
  status: Recruiting
  contact: 
  country: Spain
  citation: Holmgren T, Bjornsson Hallgren H, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. BMJ. 2012 Feb 20;344:e787. doi: 10.1136/bmj.e787.
  PMID: 22349588
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  responsible party type: Principal Investigator
  investigator affiliation: Universidad Miguel Hernandez de Elche
  investigator full name: JOSE VICENTE TOLEDO MARHUENDA
  investigator title: Principal Investigator
  mesh term: Wounds and Injuries
  mesh term: Shoulder Injuries
  sharing ipd: No
  provided document: 