Clinical trial NCT06563336: Effects of the EMG-driven Hand Robot Training in Patients With Hand Dysfunction Due to Nerve Damage From Burns
Official title: Effects of the EMG-driven Hand Robot Training in Patients With Hand Dysfunction Due to Nerve Damage From Burns
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Burn Hand
Rehabilitation
Keywords: hand burn
robot training
hand functions
skin characteristics
Lead sponsor: Hangang Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The hand represents the area of the body most common affected by burns, accounting for 80% of all burn injuries. The deformities and scarring that occur when the affected area is the hand can result in the loss of function such as grip strength, range of motion (ROM), dexterity. While early excision and grafting have been shown to reduce the loss of function in cases of burns, up to 30% of affected joints have been found to have a limited ROM.Acute hand rehabilitation tailored to the patient's condition is essential after a burn injury.However, there is still no proven hand rehabilitation protocol in burn centers, new rehabilitation modalities are being attempted to improve hand function.Robot training is being attempted to improve function in musculoskeletal diseases including burns,and the researchers have confirmed the clinical effectiveness of applying a soft glove-type hand robot for hand burns.There is still no established protocol for burn injury rehabilitation. This study was designed as a prospective, randomized controlled single-blind, case control study. 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. 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

Primary outcomes:
measure: A 10-point visual analog scale (VAS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Patients were assessed using the total active motion (TAM)
timeFrame: 12 weeks
measure: Jebsen-Taylor hand function test (JTT)
timeFrame: 12 weeks
measure: the Purdue Pegboard test (PPT)
timeFrame: 12 weeks
measure: Scar thickness
timeFrame: 12 weeks
measure: Trans-epidermal water loss (TEWL)
timeFrame: 12 weeks
measure: erythema and pigmentation
timeFrame: 12 weeks
measure: Sebum
timeFrame: 12 weeks
measure: Distensibility
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hangang sacred heart hodpital
Study officials:
References:
citation: Padilla-Castaneda MA, Sotgiu E, Barsotti M, Frisoli A, Orsini P, Martiradonna A, Laddaga C, Bergamasco M. An Orthopaedic Robotic-Assisted Rehabilitation Method of the Forearm in Virtual Reality Physiotherapy. J Healthc Eng. 2018 Aug 1;2018:7438609. doi: 10.1155/2018/7438609. eCollection 2018.
citation: Lo AC, Guarino PD, Richards LG, Haselkorn JK, Wittenberg GF, Federman DG, Ringer RJ, Wagner TH, Krebs HI, Volpe BT, Bever CT Jr, Bravata DM, Duncan PW, Corn BH, Maffucci AD, Nadeau SE, Conroy SS, Powell JM, Huang GD, Peduzzi P. Robot-assisted therapy for long-term upper-limb impairment after stroke. N Engl J Med. 2010 May 13;362(19):1772-83. doi: 10.1056/NEJMoa0911341. Epub 2010 Apr 16.