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

Duchenne Muscular Dystrophy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05244395
• Other study ID #: GO 20/1058
• Status: Completed
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: February 10, 2022

Study information

• Verified date: February 2022
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 10, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 5 Years to 18 Years

Eligibility

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

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. -

Related Conditions & MeSH terms

• Disease
• Duchenne Muscular Dystrophy
• Gait Disorders in Children
• Gait Disorders, Neurologic
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne
• Nervous System Diseases

Intervention

Other:
• Duchenne Muscular Dystrophy Gait Assessment Scale
a special gait assessment scale for Duchenne Muscular Dystrophy patients

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara	Sihhiye

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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