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

Not Applicable

Completed

• Conditions: Duchenne Muscular Dystrophy; Gait Disorders in Children; Gait Disorders, Neurologic
• Interventions: Other: Duchenne Muscular Dystrophy Gait Assessment Scale

• Registration Number: NCT05244395
• Lead Sponsor: Hacettepe University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-02-10
• Primary Completion: 2021-11-30
• Status Verified: 2022-02
• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-08
• Study Completion: 2022-02-10
• Study First Posted: 2022-02-17
• Last Update Submitted: 2022-02-18
• Last Update Posted: 2022-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 56

Inclusion Criteria

1. Being diagnosed with DMD
2. Be between Levels I-V according to Brooke Lower Limb Extremity Functional Classification
3. Being between the ages of 5-18
4. Agreeing to participate in the research voluntarily

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Exclusion Criteria

1. Insufficient cooperation with the physiotherapist,
2. Have had any injury and/or surgery of the lower extremities in the last 6 months,
3. Having neurological problems in addition to DMD. -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Duchenne Muscular Dystrophy Gait Assessment Scale	Duchenne Muscular Dystrophy Gait Assessment Scale	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.

Primary Outcome Measures

Name	Time	Method
Duchenne Muscular Dystrophy Gait Assessment Scale (DMD-GAS)	15-20 minutes	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.
Motor Function Measure (MFM)	20-30 minutes	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

Secondary Outcome Measures

Name	Time	Method
6 meter walking test (6MWT)	6 minutes	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.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Sıhhiye, Turkey