Effects of Virtual Reality Based Rehabilitation on Burned Hands
Primary Purpose
Hand Injuries
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Virtual reality rehabilitation
Sponsored by
![Hangang Sacred Heart Hospital](https://trials-media.s3.amazonaws.com/orgs/hangang-sacred-heart-hospital.jpeg)
About this trial
This is an interventional treatment trial for Hand Injuries focused on measuring burn, virtual reality
Eligibility Criteria
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.
Sites / Locations
- Hangang Sacred Heart Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Virtual reality intervention
Control group
Arm Description
Experimental group : virtual reality intervention
conventional rehabilitation without virtual reality intervention
Outcomes
Primary Outcome Measures
hand function
grip strength
Secondary Outcome Measures
Michigan Hand Outcomes Questionnaire
patient's perception of hand function
fine motor function
Jebsen-Taylor hand function test
Full Information
NCT ID
NCT03865641
First Posted
March 5, 2019
Last Updated
October 10, 2019
Sponsor
Hangang Sacred Heart Hospital
Collaborators
National Research Foundation of Korea
1. Study Identification
Unique Protocol Identification Number
NCT03865641
Brief Title
Effects of Virtual Reality Based Rehabilitation on Burned Hands
Official Title
Effects of Virtual Reality Based Rehabilitation on Burned Hands a Prospective, Randomized, Single Blined Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 28, 2019 (Actual)
Primary Completion Date
October 5, 2019 (Actual)
Study Completion Date
October 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangang Sacred Heart Hospital
Collaborators
National Research Foundation of Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injuries
Keywords
burn, virtual reality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
viartual reality based rehabilitation
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality intervention
Arm Type
Experimental
Arm Description
Experimental group : virtual reality intervention
Arm Title
Control group
Arm Type
No Intervention
Arm Description
conventional rehabilitation without virtual reality intervention
Intervention Type
Device
Intervention Name(s)
Virtual reality rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
hand function
Description
grip strength
Time Frame
4weeks
Secondary Outcome Measure Information:
Title
Michigan Hand Outcomes Questionnaire
Description
patient's perception of hand function
Time Frame
4weeks
Title
fine motor function
Description
Jebsen-Taylor hand function test
Time Frame
4weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheong Hoon Seo, M.D.
Organizational Affiliation
Hangang Sacred Heart Hospital IRB
Official's Role
Study Director
Facility Information:
Facility Name
Hangang Sacred Heart Hospital
City
Seoul
State/Province
Yeong-deungpo-Dong
ZIP/Postal Code
150-719
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
after request
Citations:
PubMed Identifier
30794762
Citation
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.
Results Reference
background
PubMed Identifier
21328164
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. doi: 10.1682/jrrd.2010.02.0013.
Results Reference
background
Learn more about this trial
Effects of Virtual Reality Based Rehabilitation on Burned Hands
We'll reach out to this number within 24 hrs