- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06295718
Tele-assessment of Functional Performance and Quality of Life in Patients With Duchenne Muscular Dystrophy: Validity and Reliability Study
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34758
- İstanbul University - Cerrahpaşa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being diagnosed with Duchenne muscular dystrophy
- Being between the ages of 5-18
- Having ambulation skills
- Having internet access and technical requirements
- Having the ability to follow movement instructions
- Volunteering to participate in the study
Exclusion Criteria:
- Having cognitive or behavioral problems that may interfere with evaluation
- Having communication problems that may prevent evaluation
- Having a level of contracture that may prevent evaluation
- Having a systemic disease that may prevent evaluation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Ambulatory Children with Duchenne Muscular Dystrophy
Participants who meet the inclusion criteria will be evaluated synchronously online using the Zoom platform in terms of the functional performance and quality of life parameters specified below, after ensuring the presence of a suitable environment and a stable internet connection. During the online evaluation, patients will be asked to perform the specified functions in front of the camera. In addition, the survey questions necessary to evaluate the quality of life will be expressed verbally to the participants. Inter-rater reliability will be examined by comparing the scores after being performed separately by two different physiotherapists. The reliability and validity of the online assessment will be investigated by repeating the same assessments online and face-to-face.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Timed Performance Tests
Time Frame: 2 days
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Timed performance tests are one of the frequently preferred outcome measures in patients with DMD.
The time patients spend performing certain functions is recorded.
The following functions will be evaluated in this study: • Getting up from the ground • Standing up from a chair • Don't wear a t-shirt • T-shirt removal • Collect 6 coins with one hand • Timed Up and Go Test
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2 days
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Brooke Upper Extremity Functional Classification (BUEFS)
Time Frame: 2 days
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Brooke Upper Extremity Functional Classification (BUEFS) will be used to evaluate the upper extremity functions of the cases.
BUEFS is a valid, reliable and practical scale used to classify the upper extremity functions of individuals with DMD.
It was developed by Brooke et al. in 1981.
Individuals are classified between 1 and 6 according to the upper extremity activities they can perform, and higher stages indicate decreased functionality of the upper extremity.
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2 days
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Vignos Lower Extremity Functional Classification (VAEFS)
Time Frame: 2 days
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Vignos Lower Extremity Functional Classification (VAEFS) will be used to evaluate the lower extremity functions of the cases.
VAEFS is a scale consisting of 10 stages that evaluates the level of ambulation in neuromuscular diseases.
It was developed by Vignos et al. in 1963.
Individuals are classified between 1 and 10 according to their ambulation level, and higher stages indicate a decrease in ambulation level.
While the patient in the first stage can walk and climb stairs without support, in the highest stage he is bedridden.
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2 days
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PedsQL-3.0 Neuromuscular Module by PedsQL Multidimensional Fatigue Scale
Time Frame: 2 days
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The patients' quality of life will be evaluated using the PedsQL-3.0
Neuromuscular Module- the PedsQL Multidimensional Fatigue Scale.
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2 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/51
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Duchenne Muscular Dystrophy
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Cairo UniversityCompletedMuscular Dystrophy, Duchenne TypeEgypt
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ItalfarmacoCompletedDuchenne Muscular Dystrophy (DMD)Italy
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Santhera PharmaceuticalsTerminatedDuchenne Muscular Dystrophy (DMD)United States, Spain, Netherlands, Sweden, Germany, France, Belgium, United Kingdom, Italy, Ireland, Switzerland, Austria, Bulgaria, Hungary, Israel
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Sarepta Therapeutics, Inc.CompletedDuchenne Muscular Dystrophy (DMD)United States
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Hospital RudolfstiftungOesterreichische MuskelforschungCompletedCarrier of Duchenne Muscular DystrophyAustria
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General Hospital of Chinese Armed Police ForcesUnknownDuchenne Muscular Dystrophy (DMD)China
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Chaitanya Hospital, PuneUnknownMuscular Dystrophy | Duchenne Muscular Dystrophy,India
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University of FloridaU.S. Army Medical Research and Development CommandRecruitingDuchenne Muscular Dystrophy (DMD)United States
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PTC TherapeuticsCompletedNonsene Mutation Duchenne Muscular DystrophyUnited States