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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05244395
Enrollment
56
Registered
2022-02-17
Start date
2020-02-10
Completion date
2022-02-10
Last updated
2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Duchenne Muscular Dystrophy, gait pattern, scale development, reliability and validity, gait analysis

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.

Interventions

OTHERDuchenne Muscular Dystrophy Gait Assessment Scale

a special gait assessment scale for Duchenne Muscular Dystrophy patients

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
5 Years to 18 Years
Healthy volunteers
No

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. -

Design outcomes

Primary

MeasureTime frameDescription
Duchenne Muscular Dystrophy Gait Assessment Scale (DMD-GAS)15-20 minutesThe 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 minutesMFM, 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

MeasureTime frameDescription
6 meter walking test (6MWT)6 minutes6MWT 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026