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

NCT05564962 | Completed

• 1 other identifier: QIGSDMD
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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).

Conditions

Duchenne Muscular Dystrophy; Gait Disorders in Children

Keywords

Duchenne Muscular Dystrophy; scale development; gait; classification; reliability; validitiy

Outcome Measures

Primary Outcomes (1)

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

  It is the scale developed within the scope of the study.

  10 minutes

Secondary Outcomes (2)

• Motor Fucntion Measure (MFM)

  20-30 minutes

• Vignos Lower Extremity Rating Scale (VLERS)

  10 minutes

Interventions

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

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.

Also known as: Motor Function Measure (MFM) and Vignos Lower Extremity Rating Scale (VLERS).

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: male
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Study population consisted of patients with Duchenne Muscular Dystrophy

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Güllü Aydın Yağcıoğlu

Isparta, 32100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

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

Study Officials

• Güllü Aydın Yağcıoğlu, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Asisstant

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 4, 2022
• Study Start: January 19, 2021
• Primary Completion: June 20, 2021
• Study Completion: September 20, 2021
• Last Updated: October 4, 2022

Record last verified: 2022-09

Locations

TU (1)