Effects of the EMG-driven Hand Robot Training in Patients With Hand Dysfunction Due to Nerve Damage From Burns
NCT Number: NCT06563336
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Burn Hand|Rehabilitation
Interventions: OTHER: EMG-driven hand robot training|OTHER: conventional occupational training
Sponsor: Hangang Sacred Heart Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-12-06
Completion Date: 2024-12-30
Locations: Hangang sacred heart hodpital, Seoul, 07247, Korea, Republic of

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.

Primary Outcome Measures: A 10-point visual analog scale (VAS), was used to measure the scar pain severity, with ratings ranging from 0 (no pain) to 10 (unbearable pain)., 12 weeks
Secondary Outcome Measures: Patients were assessed using the total active motion (TAM), The sum of the angles of flexion and extension of the metacarpophalangeal joint, proximal interphalangeal joint, and distal interphalangeal joint of each finger. A maximum of 260 degrees to a minimum of -260 degrees for each finger., 12 weeks|Jebsen-Taylor hand function test (JTT), performance speed of standardized seven tasks, each scored on a 0-15-point scale (with higher scores indicating better hand function), 12 weeks|the Purdue Pegboard test (PPT), motor function was measured as the number of pins that could be placed on the board in 30 s, with dextrity measured as the number of pins, washers, and collars that could be assembled in 60 s, 12 weeks|Scar thickness, was objectively quantified using ultrasonography (128 BW1 US system, Medison, Korea)., 12 weeks|Trans-epidermal water loss (TEWL), was measured using a Tewameter® (Courage-Khazaka Electronic GmbH, Germany) to evaluate water evaporation.Higher numbers mean drier skin., 12 weeks|erythema and pigmentation, Mexameter®(MX18, Courage-Khazaka Electronics GmbH, Germany) was used to measure the melanin levels and the severity of erythema. Higher values mean more pigmentation and reddness., 12 weeks|Sebum, was measured with the Sebumeter® (Courage-Khazaka Electronic GmbH, Germany). The microprocessor calculated the results, which were on display, in mg/cm2., 12 weeks|Distensibility, measured using Cutometer SEM 580® (Courage-Khazaka Electronic GmbH, Cologne, Germany). Two seconds of negative pressure at 450 mbar was followed by 2 s of recess, which consisted of a complete cycle.The higher the measurement value, the better the expansion., 12 weeks