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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03865641
Other study ID # HangangSHH-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 28, 2019
Est. completion date October 6, 2019

Study information

Verified date October 2019
Source Hangang Sacred Heart Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hands are the most frequent injury sites caused by burn, and appropriate rehabilitation is essential to ensure that good functional recovery is achieved. Many interventions have been developed for patients with burns; however, hand rehabilitation tools are limited. Virtual reality (VR)-based rehabilitation has proven beneficial to the functions of upper and lower extremities. To investigate VR-based rehabilitation effects on burned hands, we compare the results of VR rehabilitation group to the results of matched conventional(CON) rehabilitation group.This single-blinded, randomized, controlled trial involved 31 patients with burns and dominant right-hand function impairment. Patients were randomized into a VR or a CON group. Each intervention was applied to the affected hand for 4 weeks. Hand function was evaluated using the Jebsen-Taylor hand function test (JTT), grasp and pinch power test, and Michigan Hand Outcomes Questionnaire (MHQ). These assessments were evaluated pre-intervention and 4 weeks post-intervention.Our study results suggest that VR-based rehabilitation is likely to be as effective as conventional rehabilitation for recovering hand function in a burned hand. VR-based rehabilitation may be considered a treatment option for burned hands.


Description:

Appropriate rehabilitation is important to ensure that good functional recovery is achieved. Burned hands are usually treated and managed by a multidisciplinary team at a burn center to conservatively manage hypertrophic scars. Rehabilitation of the burned hand should be initiated in the acute stages to set individualized positioning, splinting and exercise for functional activity. Frequent exercises throughout the day are more beneficial than one intensive exercise. Repeated range of motion (ROM) exercises are helpful in decreasing edema and conditioning the tissue. Despite adequate rehabilitation of the burned hand, hand functional disorders may occur. Many interventions have been developed and trialed for patients with burns; however, hand rehabilitation tools are limited and remain controversial.

Recent studies have recommended that for the functional recovery of upper extremity disorder, repetitive exercises using VR have been useful. Task-specific training has been shown to be more effective when tasks were ordered in a random practice sequence using repetition and positive feedback. VR is an interactive and enjoyable intervention. VR creates a virtual rehabilitation scene in which the intensity of practice can be systemically manipulated. This study aimed to evaluate the effects of VR-based rehabilitation on burned hands, and compare the results to those of matched CON rehabilitation in patients with burns.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date October 6, 2019
Est. primary completion date October 5, 2019
Accepts healthy volunteers No
Gender All
Age group 19 Years to 65 Years
Eligibility Inclusion Criteria:

- The patients' burn scars had re-epithelialized after aseptic care or skin graft. We included patients aged =18 years with a deep partial-thickness (second-degree) burn or a full thickness (third-degree) burn to their hands, with joint contracture(hand and wrist), having been transferred to the rehabilitation department after acute burn treatment, and less than 6 months since the onset of the burn injury.

Exclusion Criteria:

- patients who had fourth-degree burns(involving muscles, tendons, and bone injuries), musculoskeletal diseases(fracture, amputation, rheumatoid arthritis, and degenerative joint diseases) in the burned hand, or neurological diseases(such as peripheral nerve disorders), preexisting physical and psychologic disability (severe aphasia and cognitive impairment that could influence the intervention), and severe pain impeding hand rehabilitation.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Virtual reality rehabilitation
Task-specific training has been shown to be more effective when tasks were ordered in a random practice sequence using repetition and positive feedback. VR is an interactive and enjoyable intervention. VR creates a virtual rehabilitation scene in which the intensity of practice can be systemically manipulated.

Locations

Country Name City State
Korea, Republic of Hangang Sacred Heart Hospital Seoul Yeong-deungpo-Dong

Sponsors (2)

Lead Sponsor Collaborator
Hangang Sacred Heart Hospital National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Cavalcante Neto JL, Steenbergen B, Wilson P, Zamunér AR, Tudella E. Is Wii-based motor training better than task-specific matched training for children with developmental coordination disorder? A randomized controlled trial. Disabil Rehabil. 2019 Feb 22:1-10. doi: 10.1080/09638288.2019.1572794. [Epub ahead of print] — View Citation

Li K, Chen IM, Yeo SH, Lim CK. Development of finger-motion capturing device based on optical linear encoder. J Rehabil Res Dev. 2011;48(1):69-82. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary hand function grip strength 4weeks
Secondary Michigan Hand Outcomes Questionnaire patient's perception of hand function 4weeks
Secondary fine motor function Jebsen-Taylor hand function test 4weeks
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