Burn HandNCT06563336
Effects of the EMG-driven Hand Robot Training in Patients With Hand Dysfunction Due to Nerve Damage From Burns
A study testing EMG-driven hand robot training and conventional occupational training in people with Burn Hand and Rehabilitation, run by Hangang Sacred Heart Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Burn Hand, Rehabilitation
- What is being tested?
- EMG-driven hand robot training and conventional occupational training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Dec 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hangang sacred heart hodpital
Seoul, 07247
Ragyem Sung, 82-10-5939-2541, sung6652@hallym.or.kr
About this study
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.
Read the 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.
- Conditions
- Burn Hand, Rehabilitation
- Being tested
- EMG-driven hand robot training, conventional occupational training
- Keywords
- hand burn, robot training, hand functions, skin characteristics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMG-driven hand robot trainingOther
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.
conventional occupational trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| EMG-driven hand robot training | Experimental | 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. Receives: Other: EMG-driven hand robot training; Other: conventional occupational training |
| conventioanl training | Active comparator | 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. Receives: Other: conventional occupational training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (8)
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.
Measured: 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)
Measured: 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
Measured: 12 weeks
Scar thickness
was objectively quantified using ultrasonography (128 BW1 US system, Medison, Korea).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start6 Dec 2023
- Primary completion15 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Burn HandStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangang Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563336
- Sponsor's protocol ID
- HangangSHH-19
- Status last verified
- Aug 2024
- First submitted
- 18 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30154992Lo 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.
PubMed 20400552
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the EMG-driven Hand Robot Training in Patients With Hand Dysfunction Due to Nerve Damage From Burns
- ClinicalTrials.gov ID
- NCT06563336
- Acronym / sponsor ID
- HangangSHH-19
- Conditions
- Burn Hand, Rehabilitation
- Keywords
- hand burn, robot training, hand functions, skin characteristics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hangang Sacred Heart HospitalUniversity, hospital or other
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMG-driven hand robot training | Experimental | Other: EMG-driven hand robot training, Other: conventional occupational trainingRobot 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. |
| conventioanl training | Active comparator | Other: conventional occupational trainingThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMG-driven hand robot trainingRobot 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. | Other | EMG-driven hand robot training |
| conventional occupational trainingThis 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. | Other | EMG-driven hand robot training, conventioanl training |
Primary outcome
A 10-point visual analog scale (VAS)
Time frame: 12 weeks
was used to measure the scar pain severity, with ratings ranging from 0 (no pain) to 10 (unbearable pain).
8 secondary outcomes
Patients were assessed using the total active motion (TAM)
Time frame: 12 weeks
Jebsen-Taylor hand function test (JTT)
Time frame: 12 weeks
the Purdue Pegboard test (PPT)
Time frame: 12 weeks
Scar thickness
Time frame: 12 weeks
Trans-epidermal water loss (TEWL)
Time frame: 12 weeks
erythema and pigmentation
Time frame: 12 weeks
Sebum
Time frame: 12 weeks
Distensibility
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Results publication: PubMed 30154992Padilla-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.
- Results publication: PubMed 20400552Lo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMG-driven hand robot training and conventional occupational training in people with Burn Hand and Rehabilitation, run by Hangang Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung Rakyum (82-2-2639-5900, sung6652@hallym.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A 10-point visual analog scale (VAS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06563336, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.