NCT06563336 Effects of the EMG-driven Hand Robot Training in Patients With Hand Dysfunction Due to Nerve Damage From Burns
| NCT ID | NCT06563336 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hangang Sacred Heart Hospital |
| Condition | Burn Hand |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-12-06 |
| Primary Completion | 2024-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-12-06 with a primary completion date of 2024-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Hands are the most frequent burn injury sites. Appropriate rehabilitation is essential to ensure good functional recovery. The aim of this study was to investigate the effects of EMG driven robotic rehabilitation on hand functions and skin characteristics of patients with nerve damage caused by burns. A randomized controlled, single blind trial recruited the patients with hand dysfunction after burn injury. The participants were randomly allocated to experimental group (EG) and control group (CG) for 5 days a week and totally 60 sessions for 12 weeks. The EG received robotic assisted hand training with the EMG-driven exoskeleton hand robot (Hand of Hope®.Rehab-Robotics Company) and conventional occupational therapy. The CG performed conventional occupational therapy, including hand range of motion (ROM) exercises and hand functional training twice a day for 12 weeks. Outcome measures were as follows: 10-point visual analog scale for pain, Jebsen-Taylor hand function test, grip strength, Purdue Pegboard test, joint ROMs, ultrasound measurement of scar thickness, and skin characteristics before and immediately after 12 weeks of treatment. There is still no established protocol for burn injury rehabilitation. The aim of this study was to investigate the effects of EMG driven robotic rehabilitation on hand functions and skin characteristics of patients with nerve damage and scarring caused by burns.
Eligibility Criteria
Inclusion Criteria: * ≥ 18 years old * more than 50% of the hand is burned * burns occurred on the right hand, which is the dominant hand * had a deep partial-thickness (second-degree) or a full-thickness (third-degree) burn, which had been treated with a split-thickness skin graft (STSG) after the burn injury * nerve injury to the hand was confirmed by electromyography * all patients were in the re-epithelialization phase Exclusion Criteria: * other causes of musculoskeletal diseases (rheumatoid arthritis and degenerative joint diseases et al) that may affect hand dysfunctions * unstable scars (acute infection or coagulopathy) that may cause damage to the scar area during hand treatment
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06563336 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Burn Hand. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06563336 currently recruiting?
Yes, NCT06563336 is actively recruiting participants. Contact the research team at sung6652@hallym.or.kr for enrollment information.
Where is the NCT06563336 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06563336 clinical trial?
NCT06563336 is sponsored by Hangang Sacred Heart Hospital. The trial plans to enroll 60 participants.