Effects of the EMG-driven Hand Robot Training in Patients With Hand Dysfunction Due to Nerve Damage From Burns

NCT ID: NCT06563336

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-06
• Study Completion Date: 2024-12-30

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.

Conditions

Burn Hand; Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EMG-driven hand robot 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.

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.

Group Type: EXPERIMENTAL

EMG-driven hand robot training

Intervention Type: OTHER

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 training

Intervention Type: OTHER

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.

conventioanl 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.

Group Type: ACTIVE_COMPARATOR

conventional occupational training

Intervention Type: OTHER

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.

Interventions

EMG-driven hand robot 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.

Intervention Type: OTHER

conventional occupational training

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangang Sacred Heart Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hangang sacred heart hodpital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sung Rakyum

Role: CONTACT

sung6652@hallym.or.kr

82-2-2639-5900

Facility Contacts

Ragyem Sung

Role: primary

sung6652@hallym.or.kr

82-10-5939-2541

References

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.

Reference Type: RESULT

PMID: 30154992 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20400552 (View on PubMed)

Other Identifiers

HangangSHH-19

Identifier Type: -

Identifier Source: org_study_id