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

Sponsor

Hacettepe University (Other)

Overall Status

Completed

CT.gov ID

NCT05244395

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Duchenne Muscular Dystrophy Gait Disorders in Children Gait Disorders, Neurologic	Other: Duchenne Muscular Dystrophy Gait Assessment Scale	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 10, 2020

Actual Primary Completion Date :

Nov 30, 2021

Actual Study Completion Date :

Feb 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Duchenne Muscular Dystrophy Gait Assessment Scale a special gait assessment scale for Duchenne Muscular Dystrophy patients

Arm

Intervention/Treatment

Experimental: 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.

Other: Duchenne Muscular Dystrophy Gait Assessment Scale

a special gait assessment scale for Duchenne Muscular Dystrophy patients

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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. -