Quality and Independence of Gait Classification Scale for DMD (QIGS-DMD)

Completed

• Conditions: Duchenne Muscular Dystrophy; Gait Disorders in Children

• Registration Number: NCT05564962
• Lead Sponsor: Hacettepe University

Brief Summary

The aim of this study was to develop a reliable and valid gait classification scale for Duchenne Muscular Dystrophy (QIGS-DMD). The items of the QIGS-DMD were designed based on the literature review considering existing functional classification scales, gait scales, and the opinions of the physiotherapists who were expertized in rehabilitation of patients with DMD. Content validity was determined based on the opinions of a total of ten expert physiotherapists. Videos were recorded during gait of 69 children with DMD and inter- and intra-rater reliability were examined. Criterion validity was determined according to the relationship between QIGS-DMD and Motor Function Measure (MFM) and Vignos Lower Extremity Rating Scale (VLERS).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-19
• Primary Completion: 2021-06-20
• Study Completion: 2021-09-20
• Status Verified: 2022-09
• Study First Submitted: 2022-09-29
• Study First Submitted QC: 2022-09-29
• Last Update Submitted: 2022-09-29
• Study First Posted: 2022-10-04
• Last Update Posted: 2022-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 69

Inclusion Criteria

• being 5 years old or above, and
• having a confirmed diagnosis of Duchenne Muscular Dystrophy.

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Exclusion Criteria

• having other coexisting medical or psychiatric diseases or injury and/or surgery related to the lower extremities within the last 6 months

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality and Independence of Gait Classification Scale for Duchenne Muscular Dystrophy (QIGS-DMD)	10 minutes	It is the scale developed within the scope of the study.

Secondary Outcome Measures

Name	Time	Method
Motor Fucntion Measure (MFM)	20-30 minutes	MFM is a valid and reliable measure to evaluate the severity of the motor deficit of both ambulatory and non-ambulatory children with neuromuscular diseases. MFM consists of 32 items in 3 dimensions and is scored as a percentage of the maximum possible score which higher scores indicate better functional status.
Vignos Lower Extremity Rating Scale (VLERS)	10 minutes	VLERS is a 10-item ordinal scale that identifies the functional status of the lower limbs. According to VLERS, level 1 indicates that the patient can walk independently and climb stairs without assistance while level 10 indicates is the patient is bedridden

Trial Locations

Locations (1)

Güllü Aydın Yağcıoğlu; 🇹🇷 Isparta, Turkey