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

NCT ID: NCT05564962

Last Updated: 2022-10-04

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

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-19

Study Completion Date

2021-09-20

Brief Summary

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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

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Conditions

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Duchenne Muscular Dystrophy Gait Disorders in Children

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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

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. 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Motor Function Measure (MFM) and Vignos Lower Extremity Rating Scale (VLERS).

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Güllü Aydın Yağcıoğlu, PhD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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Güllü Aydın Yağcıoğlu

Isparta, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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QIGSDMD

Identifier Type: -

Identifier Source: org_study_id

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