Skip to main content
OpenTrials
Completed

NCT Number: NCT05244395

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

5 year–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, Sıhhiye, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

Duchenne Muscular Dystrophy Gait Assessment Scale

Other

a special gait assessment scale for Duchenne Muscular Dystrophy patients

Primary outcomes

  1. Duchenne Muscular Dystrophy Gait Assessment Scale (DMD-GAS)

    Time frame: 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.

  2. Motor Function Measure (MFM)

    Time frame: 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 outcomes

  1. 6 meter walking test (6MWT)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 17, 2022
Registry last updated
Mar 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.