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

Sponsor

Hacettepe University (Other)

Overall Status

Completed

CT.gov ID

NCT05564962

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Duchenne Muscular Dystrophy Gait Disorders in Children	Diagnostic Test: Quality and Independence of Gait Classification Scale for Duchenne Muscular Dystrophy (QIGS-DMD)

Study Design

Study Type:

Observational

Actual Enrollment :

69 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 19, 2021

Actual Primary Completion Date :

Jun 20, 2021

Actual Study Completion Date :

Sep 20, 2021

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

Male

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Güllü Aydın Yağcıoğlu	Isparta		Turkey	32100

Sponsors and Collaborators

Hacettepe University

Investigators

Principal Investigator: Güllü Aydın Yağcıoğlu, PhD, Hacettepe University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Güllü AYDIN YAĞCIOĞLU, Research Asisstant, Hacettepe University

ClinicalTrials.gov Identifier:

NCT05564962

Other Study ID Numbers:

QIGSDMD

First Posted:

Oct 4, 2022

Last Update Posted:

Oct 4, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Güllü AYDIN YAĞCIOĞLU, Research Asisstant, Hacettepe University

Duchenne Muscular Dystrophy

Additional relevant MeSH terms:

Muscular Dystrophies

Muscular Dystrophy, Duchenne

Study Results

No Results Posted as of Oct 4, 2022