NCT06755138

Research on the Relationship Between Scoliosis, Pain, Quality of Life, and Trunk Muscle Compensation Patterns Among Patients with Duchenne Muscular Dystrophy.

Recruiting now Last updated 1 January 2025

What this trial tests

trial testing Observational Assessment in Duchenne Muscular Dystrophy (DMD) in 30 participants. Currently enrolling.

Timeline

24 December 2024

Primary endpoint
31 July 2026

31 August 2026

Quick facts

Lead sponsor	Seoul National University Hospital
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	30
Start date	24 December 2024
Primary completion	31 July 2026
Estimated completion	31 August 2026
Sites	1 location across South Korea

Drugs / interventions tested

• Observational Assessment

Conditions studied

• Duchenne Muscular Dystrophy (DMD) — all drugs for Duchenne Muscular Dystrophy (DMD) →

Sponsor

Seoul National University Hospital

Who can join

Adults 11 to 30, any sex, with Duchenne Muscular Dystrophy (DMD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

* 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:

1. Participants: Patients diagnosed with Duchenne Muscular Dystrophy will be recruited for this study.
2. Assessments:
* Scoliosis Evaluation:

1. Cobb angle measurement via X-ray imaging.
2. Upper Limb Function Assessment:
3. Performance of the Upper Limb Module 2.0 (PUL 2.0).
4. Brooke Upper Extremity Functional Classification Score.
5. Korean version of the Duchenne Muscular Dystrophy Functional Ability Self-Assessment Tool (K-DMDSAT).
* Pain Measurement:

1. Korean version of the PainDETECT Questionnaire (KPD-Q).
2. Short Form McGill Pain Questionnaire.
3. Quality of Life Assessment:
* Duchenne Muscular Dystrophy Quality of Life Questionnaire (DMD-QoL).

1. 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:
1. Deltoid
2. Pectoralis major
3. Trapezius
4. Biceps brachii ii. Muscles for assessing trunk compensatory actions:

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1. Sternocleidomastoid
2. Longissimus muscle
3. External oblique abdominal muscle

Publications & conference data

No peer-reviewed publications indexed yet for this trial.