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Development of a New Instrument to Evaluate Gait Characteristics of Individuals With Duchenne Muscular Dystrophy

Primary Purpose

Duchenne Muscular Dystrophy, Gait Disorders in Children, Gait Disorders, Neurologic

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Duchenne Muscular Dystrophy Gait Assessment Scale
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Duchenne Muscular Dystrophy focused on measuring Duchenne Muscular Dystrophy, gait pattern, scale development, reliability and validity, gait analysis

Eligibility Criteria

5 Years - 18 Years (Child, Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Being diagnosed with DMD
  2. Be between Levels I-V according to Brooke Lower Limb Extremity Functional Classification
  3. Being between the ages of 5-18
  4. Agreeing to participate in the research voluntarily

Exclusion Criteria:

  1. Insufficient cooperation with the physiotherapist,
  2. Have had any injury and/or surgery of the lower extremities in the last 6 months,
  3. Having neurological problems in addition to DMD. -

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Duchenne Muscular Dystrophy Gait Assessment Scale

Arm Description

The DMD-GAS was developed using the two-round Delphi method. After a detailed literature review, the items of scale were compiled. The DMD-GAS was designed to consist of 10 items and each item scored as 0,1,2. The DMD-GAS was presented to the expert group (10 physical therapists), who had experience in the management of patients with DMD. According to the scale items, it is classified as 2: no compensation, 1: minimal compensation, and 0: excessive compensation for the relevant body part.

Outcomes

Primary Outcome Measures

Duchenne Muscular Dystrophy Gait Assessment Scale (DMD-GAS)
The scale which developed specifically for DMD with this study. The DMD-GAS was designed to consist of 10 items and each item scored as 0 (excessive compensation in the relevant body part), 1 (minimal compensation) or 2 (no compensation). Low score indicate compensated gait.
Motor Function Measure (MFM)
MFM, which was valid and reliable in Neuromuscular Diseases, was used for gross motor function assessment. The items in MFM, which evaluate functions in 3 different sections (D1, standing position and transfers; D2, axial and proximal motor function; D3, distal motor function) in 32 items in total, are scored between 0-3. 0; cannot initiate any movement and maintain the starting position, 1; partially completes the exercise, 2; performs the exercise slowly and visibly clumsily, with compensations, 3; performs the exercise in the specified standard pattern. High scores indicate higher motor function and the result is expressed as a percentage of the maximum possible score to enable comparison with other scores

Secondary Outcome Measures

6 meter walking test (6MWT)
6MWT is an assessment that was developed by Balke in the 1960s and has validity and reliability for DMD patients. The maximum distance that the patient can walk in 6 minutes is recorded as meters.

Full Information

First Posted
February 8, 2022
Last Updated
February 18, 2022
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05244395
Brief Title
Development of a New Instrument to Evaluate Gait Characteristics of Individuals With Duchenne Muscular Dystrophy
Official Title
Development of a New Instrument to Evaluate Gait Characteristics of Individuals With Duchenne Muscular Dystrophy: Gait Assessment Scale for Duchenne Muscular Dystrophy, and Its Validity and Reliability
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
February 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study was to develop a gait assessment instrument for Duchenne Muscular Dystrophy patients (DMD-GAS), and investigate its validity and reliability.The scale was developed considering the expert opinions which included 10 physiotherapists who had experience in the management of patients with DMD over the 2-round Delphi method, and the Content Validity Index (CVI) was calculated. The final version of the DMD-GAS that was agreed upon the experts consisted of 10 items, and each item scored between 0 and 2. The intra-rater reliability was established by the video analysis of children with a 1-month interval and inter-rater reliability was determined by the scores of 3 physiotherapists. The criterion validity was determined by investigating the relationship between the total score of the DMD-GAS and Motor Function Measure (MFM), 6 Minute Walk Test (6MWT), and the data obtained from GAITRite system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duchenne Muscular Dystrophy, Gait Disorders in Children, Gait Disorders, Neurologic
Keywords
Duchenne Muscular Dystrophy, gait pattern, scale development, reliability and validity, gait analysis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duchenne Muscular Dystrophy Gait Assessment Scale
Arm Type
Experimental
Arm Description
The DMD-GAS was developed using the two-round Delphi method. After a detailed literature review, the items of scale were compiled. The DMD-GAS was designed to consist of 10 items and each item scored as 0,1,2. The DMD-GAS was presented to the expert group (10 physical therapists), who had experience in the management of patients with DMD. According to the scale items, it is classified as 2: no compensation, 1: minimal compensation, and 0: excessive compensation for the relevant body part.
Intervention Type
Other
Intervention Name(s)
Duchenne Muscular Dystrophy Gait Assessment Scale
Intervention Description
a special gait assessment scale for Duchenne Muscular Dystrophy patients
Primary Outcome Measure Information:
Title
Duchenne Muscular Dystrophy Gait Assessment Scale (DMD-GAS)
Description
The scale which developed specifically for DMD with this study. The DMD-GAS was designed to consist of 10 items and each item scored as 0 (excessive compensation in the relevant body part), 1 (minimal compensation) or 2 (no compensation). Low score indicate compensated gait.
Time Frame
15-20 minutes
Title
Motor Function Measure (MFM)
Description
MFM, which was valid and reliable in Neuromuscular Diseases, was used for gross motor function assessment. The items in MFM, which evaluate functions in 3 different sections (D1, standing position and transfers; D2, axial and proximal motor function; D3, distal motor function) in 32 items in total, are scored between 0-3. 0; cannot initiate any movement and maintain the starting position, 1; partially completes the exercise, 2; performs the exercise slowly and visibly clumsily, with compensations, 3; performs the exercise in the specified standard pattern. High scores indicate higher motor function and the result is expressed as a percentage of the maximum possible score to enable comparison with other scores
Time Frame
20-30 minutes
Secondary Outcome Measure Information:
Title
6 meter walking test (6MWT)
Description
6MWT is an assessment that was developed by Balke in the 1960s and has validity and reliability for DMD patients. The maximum distance that the patient can walk in 6 minutes is recorded as meters.
Time Frame
6 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being diagnosed with DMD Be between Levels I-V according to Brooke Lower Limb Extremity Functional Classification Being between the ages of 5-18 Agreeing to participate in the research voluntarily Exclusion Criteria: Insufficient cooperation with the physiotherapist, Have had any injury and/or surgery of the lower extremities in the last 6 months, Having neurological problems in addition to DMD. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Güllü Aydın Yağcıoğlu, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
State/Province
Sıhhiye
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Development of a New Instrument to Evaluate Gait Characteristics of Individuals With Duchenne Muscular Dystrophy

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