Hand InjuriesNCT03865641
Effects of Virtual Reality Based Rehabilitation on Burned Hands
A study testing Virtual reality rehabilitation in people with Hand Injuries, run by Hangang Sacred Heart Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Hand Injuries
- What is being tested?
- Virtual reality rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Jun 2019to 6 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hangang Sacred Heart Hospital
Seoul, Yeong-deungpo-Dong, 150-719
About this study
Official title: Effects of Virtual Reality Based Rehabilitation on Burned Hands a Prospective, Randomized, Single Blined Study
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.
Read the 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.
- Conditions
- Hand Injuries
- Being tested
- Virtual reality rehabilitation
- Keywords
- burn, virtual reality
- Medical subject headings
- Hand Injuries, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality rehabilitationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality intervention | Experimental | Experimental group : virtual reality intervention Receives: Device: Virtual reality rehabilitation |
| Control group | No intervention | conventional rehabilitation without virtual reality intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
hand function
grip strength
Measured: 4weeks
Secondary outcomes (2)
Michigan Hand Outcomes Questionnaire
patient's perception of hand function
Measured: 4weeks
fine motor function
Jebsen-Taylor hand function test
Measured: 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start28 Jun 2019
- Primary completion5 Oct 2019
- Study completion6 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- viartual reality based rehabilitation
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangang Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Sponsor
- Investigators
- Cheong Hoon Seo, M.D., Study director, Hangang Sacred Heart Hospital IRB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865641
- Sponsor's protocol ID
- HangangSHH-2
- Status last verified
- Oct 2019
- First submitted
- 5 Mar 2019
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: after request
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.
PubMed 30794762Li 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.
PubMed 21328164
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality Based Rehabilitation on Burned Hands a Prospective, Randomized, Single Blined Study
- ClinicalTrials.gov ID
- NCT03865641
- Acronym / sponsor ID
- HangangSHH-2
- Conditions
- Hand Injuries
- Keywords
- burn, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Hangang Sacred Heart HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 5 Oct 2019 (actual)
- Study completion
- 6 Oct 2019 (actual)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- viartual reality based rehabilitation
| Arm | Type | Receives |
|---|---|---|
| Virtual reality intervention | Experimental | Device: Virtual reality rehabilitationExperimental group : virtual reality intervention |
| Control group | No intervention | –conventional rehabilitation without virtual reality intervention |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality rehabilitationTask-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. | Device | Virtual reality intervention |
Primary outcome
hand function
Time frame: 4weeks
grip strength
2 secondary outcomes
Michigan Hand Outcomes Questionnaire
Time frame: 4weeks
fine motor function
Time frame: 4weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Background: PubMed 30794762Cavalcante 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.
- Background: PubMed 21328164Li 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.
- Individual participant dataSharing planned: No. after request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheong Hoon Seo, M.D. study director
Hangang Sacred Heart Hospital IRB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality rehabilitation in people with Hand Injuries, run by Hangang Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hand function (time frame: 4weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03865641, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019.