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The Effect of Telerehabilitation of Patients With Duchenne Muscular Dystrophy

Primary Purpose

Duchenne Muscular Dystrophy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telerehabilitaton
Home exercise
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Duchenne Muscular Dystrophy

Eligibility Criteria

6 Years - 18 Years (Child, Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with Duchenne muscular dystrophy

Exclusion Criteria:

  • Patients without the ability of independent ambulation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Telerehabilitation

    Home exercise

    Arm Description

    Outcomes

    Primary Outcome Measures

    Quick motor function test

    Secondary Outcome Measures

    Full Information

    First Posted
    March 2, 2021
    Last Updated
    March 2, 2021
    Sponsor
    Marmara University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04782440
    Brief Title
    The Effect of Telerehabilitation of Patients With Duchenne Muscular Dystrophy
    Official Title
    The Effect of Telerehabilitation of Patients With Duchenne Muscular Dystrophy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2021 (Anticipated)
    Primary Completion Date
    August 2021 (Anticipated)
    Study Completion Date
    September 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Marmara University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to investigate the effect of a telerehabilitation approach to patients with Duchenne Muscular Dystrophy and evaluate patients' motor function, parents' anxiety and depression levels before and after the intervention

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Duchenne Muscular Dystrophy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Telerehabilitation
    Arm Type
    Experimental
    Arm Title
    Home exercise
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    Telerehabilitaton
    Intervention Description
    Patients will receive telerehabilitation sessions that include strengthening, stretching and range of motion exercises
    Intervention Type
    Other
    Intervention Name(s)
    Home exercise
    Intervention Description
    Patients will be given a home-based exercise program without telerehabilitation supervision
    Primary Outcome Measure Information:
    Title
    Quick motor function test
    Time Frame
    2 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with Duchenne muscular dystrophy Exclusion Criteria: Patients without the ability of independent ambulation

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    The Effect of Telerehabilitation of Patients With Duchenne Muscular Dystrophy

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