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

Duchenne Muscular Dystrophy Clinical Trial

Official title:

Quality and Independence of Gait Classification Scale for Duchenne Muscular Dystrophy (QIGS-DMD): The Development, Validity and Reliability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05564962
• Other study ID #: QIGSDMD
• Status: Completed
• Start date: January 19, 2021
• Est. completion date: September 20, 2021

Study information

• Verified date: September 2022
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: September 20, 2021
• Est. primary completion date: June 20, 2021
• Gender: Male
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Duchenne Muscular Dystrophy
• Gait Disorders in Children
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Turkey	Güllü Aydin Yagcioglu	Isparta

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Motor Fucntion Measure (MFM)	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.	20-30 minutes
Secondary	Vignos Lower Extremity Rating Scale (VLERS)	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	10 minutes