Development of a New Instrument to Evaluate Gait Characteristics of Individuals With Duchenne Muscular Dystrophy

Study Overview
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Brief Summary
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The aim of this study was to develop a gait assessment instrument for Duchenne Muscular Dystrophy patients (DMD-GAS), and investigate its validity and reliability.The scale was developed considering the expert opinions which included 10 physiotherapists who had experience in the management of patients with DMD over the 2-round Delphi method, and the Content Validity Index (CVI) was calculated. The final version of the DMD-GAS that was agreed upon the experts consisted of 10 items, and each item scored between 0 and 2. The intra-rater reliability was established by the video analysis of children with a 1-month interval and inter-rater reliability was determined by the scores of 3 physiotherapists. The criterion validity was determined by investigating the relationship between the total score of the DMD-GAS and Motor Function Measure (MFM), 6 Minute Walk Test (6MWT), and the data obtained from GAITRite system.

Official Title
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Development of a New Instrument to Evaluate Gait Characteristics of Individuals With Duchenne Muscular Dystrophy: Gait Assessment Scale for Duchenne Muscular Dystrophy, and Its Validity and Reliability

Conditions
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Duchenne Muscular Dystrophy, Gait Disorders in Children, Gait Disorders, Neurologic

Intervention / Treatment
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* Other: Duchenne Muscular Dystrophy Gait Assessment Scale


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being diagnosed with DMD Be between Levels I-V according to Brooke Lower Limb Extremity Functional Classification Being between the ages of 5-18 Agreeing to participate in the research voluntarily Exclusion Criteria: Insufficient cooperation with the physiotherapist, Have had any injury and/or surgery of the lower extremities in the last 6 months, Having neurological problems in addition to DMD. -

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duchenne Muscular Dystrophy Gait Assessment Scale<br>The DMD-GAS was developed using the two-round Delphi method. After a detailed literature review, the items of scale were compiled. The DMD-GAS was designed to consist of 10 items and each item scored as 0,1,2. The DMD-GAS was presented to the expert group (10 physical therapists), who had experience in the management of patients with DMD. According to the scale items, it is classified as 2: no compensation, 1: minimal compensation, and 0: excessive compensation for the relevant body part. | Other: Duchenne Muscular Dystrophy Gait Assessment Scale<br>* a special gait assessment scale for Duchenne Muscular Dystrophy patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duchenne Muscular Dystrophy Gait Assessment Scale (DMD-GAS) | The scale which developed specifically for DMD with this study. The DMD-GAS was designed to consist of 10 items and each item scored as 0 (excessive compensation in the relevant body part), 1 (minimal compensation) or 2 (no compensation). Low score indicate compensated gait. | 15-20 minutes | 
| Motor Function Measure (MFM) | MFM, which was valid and reliable in Neuromuscular Diseases, was used for gross motor function assessment. The items in MFM, which evaluate functions in 3 different sections (D1, standing position and transfers; D2, axial and proximal motor function; D3, distal motor function) in 32 items in total, are scored between 0-3. 0; cannot initiate any movement and maintain the starting position, 1; partially completes the exercise, 2; performs the exercise slowly and visibly clumsily, with compensations, 3; performs the exercise in the specified standard pattern. High scores indicate higher motor function and the result is expressed as a percentage of the maximum possible score to enable comparison with other scores | 20-30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 meter walking test (6MWT) | 6MWT is an assessment that was developed by Balke in the 1960s and has validity and reliability for DMD patients. The maximum distance that the patient can walk in 6 minutes is recorded as meters. | 6 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Duchenne Muscular Dystrophy, gait pattern, scale development, reliability and validity, gait analysis