- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03865641
Effects of Virtual Reality Based Rehabilitation on Burned Hands
Effects of Virtual Reality Based Rehabilitation on Burned Hands a Prospective, Randomized, Single Blined Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Yeong-deungpo-Dong
-
Seoul, Yeong-deungpo-Dong, Korea, Republic of, 150-719
- Hangang Sacred Heart Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual reality intervention
Experimental group : virtual reality intervention
|
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.
|
|
No Intervention: Control group
conventional rehabilitation without virtual reality intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
hand function
Time Frame: 4weeks
|
grip strength
|
4weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Michigan Hand Outcomes Questionnaire
Time Frame: 4weeks
|
patient's perception of hand function
|
4weeks
|
|
fine motor function
Time Frame: 4weeks
|
Jebsen-Taylor hand function test
|
4weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Cheong Hoon Seo, M.D., Hangang Sacred Heart Hospital IRB
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HangangSHH-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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