NCT03865641

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

June 28, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2019

Completed
Last Updated

October 14, 2019

Status Verified

October 1, 2019

Enrollment Period

3 months

First QC Date

March 5, 2019

Last Update Submit

October 10, 2019

Conditions

Keywords

burnvirtual reality

Outcome Measures

Primary Outcomes (1)

  • hand function

    grip strength

    4weeks

Secondary Outcomes (2)

  • Michigan Hand Outcomes Questionnaire

    4weeks

  • fine motor function

    4weeks

Study Arms (2)

Virtual reality intervention

EXPERIMENTAL

Experimental group : virtual reality intervention

Device: Virtual reality rehabilitation

Control group

NO INTERVENTION

conventional rehabilitation without virtual reality intervention

Interventions

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.

Virtual reality intervention

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangang Sacred Heart Hospital

Seoul, Yeong-deungpo-Dong, 150-719, South Korea

Location

Related Publications (2)

  • Cavalcante Neto JL, Steenbergen B, Wilson P, Zamuner 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. 2020 Sep;42(18):2611-2620. doi: 10.1080/09638288.2019.1572794. Epub 2019 Feb 22.

    PMID: 30794762BACKGROUND
  • 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. doi: 10.1682/jrrd.2010.02.0013.

    PMID: 21328164BACKGROUND

MeSH Terms

Conditions

Hand InjuriesBurns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Cheong Hoon Seo, M.D.

    Hangang Sacred Heart Hospital IRB

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: viartual reality based rehabilitation
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2019

First Posted

March 7, 2019

Study Start

June 28, 2019

Primary Completion

October 5, 2019

Study Completion

October 6, 2019

Last Updated

October 14, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

after request

Locations