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The Effect of Telerehabilitation of Patients With Duchenne Muscular Dystrophy

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ClinicalTrials.gov Identifier: NCT04782440
Recruitment Status : Not yet recruiting
First Posted : March 4, 2021
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Marmara University

Tracking Information
First Submitted Date  ICMJE March 2, 2021
First Posted Date  ICMJE March 4, 2021
Last Update Posted Date March 4, 2021
Estimated Study Start Date  ICMJE April 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2021)
Quick motor function test [ Time Frame: 2 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Telerehabilitation of Patients With Duchenne Muscular Dystrophy
Official Title  ICMJE The Effect of Telerehabilitation of Patients With Duchenne Muscular Dystrophy
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Duchenne Muscular Dystrophy
Intervention  ICMJE
  • Other: Telerehabilitaton
    Patients will receive telerehabilitation sessions that include strengthening, stretching and range of motion exercises
  • Other: Home exercise
    Patients will be given a home-based exercise program without telerehabilitation supervision
Study Arms  ICMJE
  • Experimental: Telerehabilitation
    Intervention: Other: Telerehabilitaton
  • Active Comparator: Home exercise
    Intervention: Other: Home exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 2, 2021)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with Duchenne muscular dystrophy

Exclusion Criteria:

  • Patients without the ability of independent ambulation
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04782440
Other Study ID Numbers  ICMJE 1455
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Marmara University
Study Sponsor  ICMJE Marmara University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Marmara University
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP