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

NCT05244395 | Completed

• 1 other identifier: GO 20/1058
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 6 meter walking test (6MWT)

  6 minutes

Study Arms (1)

Duchenne Muscular Dystrophy Gait Assessment Scale

EXPERIMENTAL

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

Interventions

Duchenne Muscular Dystrophy Gait Assessment Scale OTHER

a special gait assessment scale for Duchenne Muscular Dystrophy patients

Duchenne Muscular Dystrophy Gait Assessment Scale

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Sıhhiye, 06100, Turkey (Türkiye)

Location

Related Publications (1)

• Aydin Yagcioglu G, Alemdaroglu Gurbuz I, Topuz S, Yilmaz O. 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. Early Hum Dev. 2023 Oct;185:105843. doi: 10.1016/j.earlhumdev.2023.105843. Epub 2023 Aug 23.

  PMID: 37672897 DERIVED

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Güllü Aydın Yağcıoğlu, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 17, 2022
• Study Start: February 10, 2020
• Primary Completion: November 30, 2021
• Study Completion: February 10, 2022
• Last Updated: March 7, 2022

Record last verified: 2022-02

Locations

TU (1)