An interventional study of EMG-driven hand robot training and conventional occupational training in Burn Hand and Rehabilitation, sponsored by Hangang Sacred Heart Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-20.
Sponsored by Hangang Sacred Heart Hospital · Not applicable, Interventional, and Treatment
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.
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.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 663 interventional studies indexed under Burns.
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Robot rehabilitation program was applied with Hand of Hope®(Rehab-Robotics Company, Hong Kong), and EMG-driven exoskeleton. The biggest advantage of this system is that it measures the residual muscle activity values with surface EMG(sEMG) sensors. The residual muscles activity is used by giving feedback to the patient. Participants in the experimental group and the control group received 60 sessions of hand rehabilitation programs delivered 5 times a week over 12 weeks. Experimental group performed robotic rehabilitation for 30 minutes and conventional occupational treatment for 30 minutes a day.
Other: EMG-driven hand robot training · Other: conventional occupational training
The control group performed 30-minutes conventional occupational treatment twice a day. In both groups, the hand rehabilitation program was carried out at the same time and interval for 60 minutes a day.
Other: conventional occupational training
Robot rehabilitation program was applied with Hand of Hope®(Rehab-Robotics Company, Hong Kong), and EMG-driven exoskeleton. The biggest advantage of this system is that it measures the residual muscle activity values with surface EMG(sEMG) sensors. The residual muscles activity is used by giving feedback to the patient. This treatment program, which was applied to both groups in the study, consisted of joint range of motion (ROM) exercises, stretching exercises for burn scars, strengthening exercises using putty or bands, and fine motor training such as writing and using a chopstick.
This treatment program, which was applied to both groups in the study, consisted of joint range of motion (ROM) exercises, stretching exercises for burn scars, strengthening exercises using putty or bands, and fine motor training such as writing and using a chopstick.
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).
Time frame: 12 weeks
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.
Time frame: 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)
Time frame: 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
Time frame: 12 weeks
Scar thickness
was objectively quantified using ultrasonography (128 BW1 US system, Medison, Korea).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Plan to share: No
Started Dec 2023 (actual). Primary completion is estimated for Dec 2024, 12 months after the start.
Of 210 non-industry interventional studies with no phase under Burns, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 12 months is below that.
Counting every sponsor, half of 239 studies reached it within 15 months; a quarter within 6 and three quarters within 38.
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Hangang Sacred Heart Hospital