Effects of the EMG-driven Hand Robot Training in Patients With Hand Dysfunction Due to Nerve Damage From Burns
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHangang Sacred Heart Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
≥ 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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
EMG-driven hand robot training
Other interventionRobot 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.
conventional occupational training
Other interventionThis 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: EMG-driven hand robot trainingExperimental treatment 2 interventions
Group B: conventioanl trainingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
Scar thickness
was objectively quantified using ultrasonography (128 BW1 US system, Medison, Korea).
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov