Duchenne Muscular Dystrophy (DMD)NCT06755138
Research on the Relationship Between Scoliosis, Pain, Quality of Life, and Trunk Muscle Compensation Patterns Among Patients with Duchenne Muscular Dystrophy.
An observational study of Duchenne Muscular Dystrophy (DMD), run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Duchenne Muscular Dystrophy (DMD)
- What is being tested?
- Observational Assessment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Dec 2024to 31 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study will recruit participants from two populations: individuals with Duchenne Muscular Dystrophy (DMD) and age-matched healthy controls. The DMD group includes subjects aged 10-30 years with a confirmed genetic diagnosis, Brooke Scale scores of 2-5, and shoulder abduction strength below grade 3 on the Manual Muscle Test (MMT). These participants represent a population with progressive neuromuscular decline and compensatory trunk muscle activity. The healthy control group consists of subjects aged 10-30 years matched to recruited DMD groups, with no history of musculoskeletal or neuromuscular disorders and shoulder strength of grade 4+ or higher on the MMT. Both groups must understand study procedures and provide informed consent. This population ensures a meaningful comparison of trunk compensatory movement patterns between DMD patients and healthy individuals, offering valuable insights into functional adaptations and their implications for care.
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Sungbae Jo Research professor, Ph. D, 82-10-9381-2299, rew277@gmail.com
About this study
Official title: 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.
Read more
- Key Research Questions:
- 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:
- 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:
- 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
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Being tested
- Observational Assessment
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational AssessmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| DMD group | Duchenne muscular dystrophy group for analysis Receives: Other: Observational Assessment | |
| 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 Receives: Other: Observational Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface Electromyography (sEMG)
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.
Measured: enrollment, 6 months after, and 12 months after since the enrollment
Computer Vision-Based Video Analysis
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.
Measured: enrollment, 6 months after, and 12 months after since the enrollment
Secondary outcomes (6)
Brooke Score
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
Measured: enrollment, 6 months after, and 12 months after since the enrollment
Performance of the Upper Limb Module 2.0 (PUL 2.0)
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.
Measured: 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)
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.
Measured: enrollment, 6 months after, and 12 months after since the enrollment
Korean version of the PainDETECT Questionnaire (KPD-Q)
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
Measured: enrollment, 6 months after, and 12 months after since the enrollment
Short Form McGill Pain Questionnaire (SF-MPQ) Korean version
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).
Measured: enrollment, 6 months after, and 12 months after since the enrollment
Duchenne Muscular Dystrophy Quality of Life Questionnaire (DMD-QoL)
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.
Measured: enrollment, 6 months after, and 12 months after since the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start24 Dec 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular Dystrophy (DMD)Studies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woo Hyung Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755138
- Sponsor's protocol ID
- 0420240390
- Status last verified
- Dec 2024
- First submitted
- 24 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06755138
- Acronym / sponsor ID
- 0420240390
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 24 Dec 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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:
- 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:
- 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:
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMD group | – | Other: Observational AssessmentDuchenne muscular dystrophy group for analysis |
| Healthy control group | – | Other: Observational AssessmentHealthy age-matched group to compare scoliosis, upper limb function level, pain, quality of life, and trunk muscle compensation patterns using sEMG and computer vision |
Who may qualify
- Ages
- 11 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study will recruit participants from two populations: individuals with Duchenne Muscular Dystrophy (DMD) and age-matched healthy controls. The DMD group includes subjects aged 10-30 years with a confirmed genetic diagnosis, Brooke Scale scores of 2-5, and shoulder abduction strength below grade 3 on the Manual Muscle Test (MMT). These participants represent a population with progressive neuromuscular decline and compensatory trunk muscle activity. The healthy control group consists of subjects aged 10-30 years matched to recruited DMD groups, with no history of musculoskeletal or neuromuscular disorders and shoulder strength of grade 4+ or higher on the MMT. Both groups must understand study procedures and provide informed consent. This population ensures a meaningful comparison of trunk compensatory movement patterns between DMD patients and healthy individuals, offering valuable insights into functional adaptations and their implications for care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational AssessmentThis 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 | Other | DMD group, Healthy control group |
Primary outcome
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.
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.
6 secondary outcomes
Brooke Score
Time frame: 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
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
Korean version of the PainDETECT Questionnaire (KPD-Q)
Time frame: 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
Duchenne Muscular Dystrophy Quality of Life Questionnaire (DMD-QoL)
Time frame: enrollment, 6 months after, and 12 months after since the enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Duchenne Muscular Dystrophy (DMD), run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sungbae Jo Research professor, Ph. D (82-10-9381-2299, rew277@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surface Electromyography (sEMG) (time frame: enrollment, 6 months after, and 12 months after since the enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.