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

NCT06563336 | Recruiting DMC

• 1 other identifier: HangangSHH-19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn Hand; Rehabilitation

Keywords

hand burn; robot training; hand functions; skin characteristics

Outcome Measures

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).

  12 weeks

Secondary Outcomes (8)

• Patients were assessed using the total active motion (TAM)

  12 weeks

• Jebsen-Taylor hand function test (JTT)

  12 weeks

• the Purdue Pegboard test (PPT)

  12 weeks

• Scar thickness

  12 weeks

• Trans-epidermal water loss (TEWL)

  12 weeks

Study Arms (2)

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.

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.

Other: conventional occupational training

Interventions

EMG-driven hand robot training 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.

EMG-driven hand robot training

conventional occupational training 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.

EMG-driven hand robot training; conventioanl training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hangang Sacred Heart Hospital: lead

Study Sites (1)

Hangang sacred heart hodpital

Seoul, 07247, South Korea

RECRUITING

Related Publications (2)

• 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.

  PMID: 30154992 RESULT

• 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.

  PMID: 20400552 RESULT

Central Study Contacts

Sung Rakyum

CONTACT

82-2-2639-5900; sung6652@hallym.or.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome measurements were performed at baseline and immediately after 12 weeks rehabilitation. The outcome measurements and data analyses were performed by a trained and blinded outcome assessor who was not involved in the intervention.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 20, 2024
• Study Start: December 6, 2023
• Primary Completion: December 15, 2024
• Study Completion: December 30, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)