- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06755138
Research on the Relationship Between Scoliosis, Pain, Quality of Life, and Trunk Muscle Compensation Patterns Among Patients with Duchenne Muscular Dystrophy.
Research on the Relationship Between Scoliosis, Pain, Quality of Life, and Trunk Muscle Compensation Patterns During Functional Upper Extremity Movements Among Patients with Duchenne Muscular Dystrophy Using Surface Electromyography and Computer Vision Analysis.
- Objective:
The objective of this observational study is to evaluate and quantify trunk muscle compensatory movement patterns in patients with Duchenne Muscular Dystrophy (DMD) using computer vision technology. Additionally, the study seeks to explore the relationship between these compensatory patterns and scoliosis, upper limb function, pain levels, and quality of life during functional upper limb movements.
Key Research Questions:
1) Can trunk compensatory movement patterns be accurately measured using computer vision analysis? 2) Are these compensatory patterns correlated with scoliosis, upper limb function levels, pain, and quality of life? 3) Do these patterns and their correlations change over time?
Methodology:
- Participants: Patients diagnosed with Duchenne Muscular Dystrophy will be recruited for this study.
- Assessments:
Scoliosis Evaluation:
- Cobb angle measurement via X-ray imaging.
- Upper Limb Function Assessment:
- Performance of the Upper Limb Module 2.0 (PUL 2.0).
- Brooke Upper Extremity Functional Classification Score.
- Korean version of the Duchenne Muscular Dystrophy Functional Ability Self-Assessment Tool (K-DMDSAT).
Pain Measurement:
- Korean version of the PainDETECT Questionnaire (KPD-Q).
- Short Form McGill Pain Questionnaire.
- Quality of Life Assessment:
Duchenne Muscular Dystrophy Quality of Life Questionnaire (DMD-QoL).
- Trunk Compensation Analysis:
- Surface electromyography (sEMG) to measure muscle activation.
- Video analysis using computer vision to quantify trunk compensatory movement patterns.
The following tasks will be evaluated using the dominant arm for sEMG and video analysis:
i. Pouring water into a cup. ii. Lifting a cup to drink water. iii. Grooming the front of the hair. iv. Moving small blocks within one minute (Box and Block Test). v. Reaching toward nearby objects in the front, left, and right directions.
- Front: Directly in front of the participant's line of sight.
- Left and right: Approximately 45 degrees to the left and right from the participant's front.
- Nearby objects: A water bottle or cup weighing approximately 250g, placed at arm's length.
vi. Reaching toward distant objects in the front, left, and right directions.
- Distant objects: A water bottle or cup weighing approximately 250g, placed at 1.5 times the participant's arm length.
The sEMG attachment sites are as follows:
i. Muscles for assessing upper limb functional movements:
- Deltoid
- Pectoralis major
- Trapezius
- Biceps brachii ii. Muscles for assessing trunk compensatory actions:
- Sternocleidomastoid
- Longissimus muscle
- External oblique abdominal muscle
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sungbae Jo Research professor, Ph. D
- Phone Number: 82-10-9381-2299
- Email: rew277@gmail.com
Study Locations
-
-
-
Seoul, Korea, Republic of, 03080
- Recruiting
- Seoul National University Hospital
-
Contact:
- Sungbae Jo Research professor, Ph. D
- Phone Number: 82-10-9381-2299
- Email: rew277@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria (1) Duchenne Muscular Dystrophy (DMD) Group
- Individuals with a confirmed genetic diagnosis of Duchenne Muscular Dystrophy.
- Aged over 10 years but under 30 years.
- Brooke Scale score between 2 and 5.
Shoulder abductor muscle strength below grade 3 on the Manual Muscle Test (MMT).
(2) Healthy Control Group
- Individuals with no history or current diagnosis of musculoskeletal or neuromuscular disorders.
- Aged over 10 years but under 30 years.
- Shoulder muscle strength of grade 4+ or higher on the Manual Muscle Test (MMT).
- Individuals capable of understanding a detailed explanation of the study procedures and voluntarily providing written informed consent.
Exclusion Criteria (1) Duchenne Muscular Dystrophy (DMD) Group
- Individuals unable or unwilling to provide informed consent.
- Brooke Scale score of 1 or 6.
- Severe cognitive impairment preventing the performance of simple tasks. (2) Healthy Control Group
- Individuals unable or unwilling to provide informed consent.
- Shoulder muscle strength of grade 4 or lower on the Manual Muscle Test (MMT).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
DMD group
Duchenne muscular dystrophy group for analysis
|
This study includes the use of surface electromyography (sEMG), video analysis, and questionnaires to assess trunk compensation patterns and their relationship with scoliosis, functional, quality-of-life, and pain parameters
|
|
Healthy control group
Healthy age-matched group to compare scoliosis, upper limb function level, pain, quality of life, and trunk muscle compensation patterns using sEMG and computer vision
|
This study includes the use of surface electromyography (sEMG), video analysis, and questionnaires to assess trunk compensation patterns and their relationship with scoliosis, functional, quality-of-life, and pain parameters
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surface Electromyography (sEMG)
Time Frame: enrollment, 6 months after, and 12 months after since the enrollment
|
The purpose of using surface electromyography (sEMG) in this study is to measure and analyze the activation levels and patterns of trunk compensatory muscles during the performance of functional upper limb movements.
This assessment aims to understand how trunk muscles compensate for upper limb movements, particularly in relation to task performance efficiency.
|
enrollment, 6 months after, and 12 months after since the enrollment
|
|
Computer Vision-Based Video Analysis
Time Frame: enrollment, 6 months after, and 12 months after since the enrollment
|
Videos are recorded simultaneously with surface electromyography (sEMG) while participants perform functional upper limb movements. Recordings are taken from two perspectives: the front view and the dominant arm side view, with synchronized matching of the videos. Video recording is conducted using a video camera mounted on a fixed tripod. The recorded videos are analyzed using a convolutional neural network (CNN)-based body part detection model, producing skeleton-based outputs for movement analysis. The relative trunk motion of the participant is extracted as positional coordinates over time, which are further processed to calculate velocity, acceleration, and jerk. These time-series signals are analyzed for smoothness and sample entropy. By matching the movement data with corresponding sEMG signals, biomechanical compensatory parameters are identified and key compensatory features are derived. Comparative analyses with healthy controls are performed to validate these parameters. |
enrollment, 6 months after, and 12 months after since the enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brooke Score
Time Frame: enrollment, 6 months after, and 12 months after since the enrollment
|
The Brooke Score is a functional assessment tool specifically designed to evaluate upper limb abilities in patients with Duchenne Muscular Dystrophy (DMD). An occupational therapist or physical therapist instructs participants to perform specific movements, and the assessment is based on the participant's ability to successfully complete these tasks. The scale ranges from 1 to 6, with lower scores indicating better upper limb function |
enrollment, 6 months after, and 12 months after since the enrollment
|
|
Performance of the Upper Limb Module 2.0 (PUL 2.0)
Time Frame: enrollment, 6 months after, and 12 months after since the enrollment
|
A functional scale specifically designed to evaluate upper limb abilities in patients with Duchenne Muscular Dystrophy (DMD), assessed by an occupational or physical therapist.
It consists of 22 items divided into three levels: shoulder level (6 items, maximum score 12), mid-level (9 items, maximum score 17), and distal level (7 items, maximum score 13), with a total possible score of 44.
Each level is scored separately, and participants are instructed to perform specific tasks, with their performance evaluated accordingly.
|
enrollment, 6 months after, and 12 months after since the enrollment
|
|
Korean version of the Duchenne Muscular Dystrophy Functional Ability Self-Assessment Tool (K-DMDSAT)
Time Frame: enrollment, 6 months after, and 12 months after since the enrollment
|
A patient-reported outcome measure designed to evaluate and describe the functional status of individuals with Duchenne Muscular Dystrophy (DMD) across the disease progression.
It comprises four domains: arm function, walking, mobility, and respiratory support.
Patients are asked to select the most difficult task they can still perform.
The tool demonstrates excellent reliability, with inter-rater and test-retest reliability scores (ICC 0.958 and 0.987, respectively).
Scoring ranges from 0-8 for arm function and walking, 0-10 for mobility, and 0-2 for respiratory support, with a total maximum score of 28.
|
enrollment, 6 months after, and 12 months after since the enrollment
|
|
Korean version of the PainDETECT Questionnaire (KPD-Q)
Time Frame: enrollment, 6 months after, and 12 months after since the enrollment
|
A tool developed to assess neuropathic pain and is also applicable for evaluating other types of pain.
It evaluates four domains: pain intensity, location, pattern, and radiating pain, with a total maximum score of 38.
Based on the score, pain can be classified into nociceptive pain, unclear pain, or neuropathic pain categories
|
enrollment, 6 months after, and 12 months after since the enrollment
|
|
Short Form McGill Pain Questionnaire (SF-MPQ) Korean version
Time Frame: enrollment, 6 months after, and 12 months after since the enrollment
|
a self-reported tool designed to assess both the quality and intensity of subjective pain.
It includes 11 adjectives describing the sensory aspects of pain and 4 adjectives related to its emotional impact.
Participants also rate their current pain intensity on a scale from 0 (no pain) to 5 (worst possible pain) and indicate the overall intensity of their pain on a 10 cm visual analog scale (VAS).
|
enrollment, 6 months after, and 12 months after since the enrollment
|
|
Duchenne Muscular Dystrophy Quality of Life Questionnaire (DMD-QoL)
Time Frame: enrollment, 6 months after, and 12 months after since the enrollment
|
Specifically designed to reflect the unique needs and experiences of individuals with Duchenne Muscular Dystrophy (DMD).
It comprises 14 items across key domains, including physical health, emotional well-being, social functioning, school and academics, pain and symptom management, and independence and autonomy.
Participants respond using a Likert scale to indicate the degree of agreement or frequency for each item.
While the questionnaire is intended to be self-reported, caregivers or guardians may complete it on behalf of the patient if age or cognitive function limits independent completion.
|
enrollment, 6 months after, and 12 months after since the enrollment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0420240390
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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