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

NCT ID: NCT05244395

Last Updated: 2022-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-10

Study Completion Date

2022-02-10

Brief Summary

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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.

Detailed Description

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Conditions

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Duchenne Muscular Dystrophy Gait Disorders in Children Gait Disorders, Neurologic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Duchenne Muscular Dystrophy Gait Assessment Scale

Intervention Type OTHER

a special gait assessment scale for Duchenne Muscular Dystrophy patients

Interventions

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Duchenne Muscular Dystrophy Gait Assessment Scale

a special gait assessment scale for Duchenne Muscular Dystrophy patients

Intervention Type OTHER

Eligibility Criteria

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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. -
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Güllü AYDIN YAĞCIOĞLU

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Güllü Aydın Yağcıoğlu, PhD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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Hacettepe University

Ankara, Sıhhiye, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 37672897 (View on PubMed)

Other Identifiers

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GO 20/1058

Identifier Type: -

Identifier Source: org_study_id

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