BurnsadultburnNCT04677764
Virtual Reality in Lower Limb Adult Burn
A study testing virtual reality in people with Burns, run by Qassim University.
Trial summary
To investigate the potential effects of Wii fit rehabilitation programs on functional capacity, mobility, balance and muscle strength in lower limb burn patients after hospital discharge. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Burns
- What is being tested?
- virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 20 Aug 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adult with a deep partial thickness or a full thickness burn in the lower extremities.
- induced by either a scaled or a flame thermal burn.
- total body surface area (TBSA) more than 40%.
- age ranged from 18 to 40 years.
- recent hospital discharge.
Who cannot join
- Infection.
- Diabetes.
- inhalation injury.
- Fracture.
- degenerative joint diseases of the lower extremities.
- peripheral nerve diseases.
- Pre-established psychologically and physically disorders.
About this study
Official title: Efficacy of Wii Fit Training on Lower Limb Burn in Adults
To investigate the potential effects of Wii fit rehabilitation programs on functional capacity, mobility, balance and muscle strength in lower limb burn patients after hospital discharge.
Read the detailed description
The use of virtual reality technology in burn conditions improved joint flexibility and reduced pain associated with physical therapy, dressing changes, and wound debridement. However, the primary concern of burn rehabilitation is not only survival but also maximizing functional outcome and decreasing the time for return to work.
- Conditions
- Burns
- Being tested
- virtual reality, Standard of care
- Keywords
- burns, lower limb burns, virtual reality
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityOther
Also called interactive video games
Wii Fit balance board (Nintendo Inc., Kyoto, Japan).
Standard of careOther
Also called routine physical therapy protocol
physical therapy and occupational therapy exercises either at their own home or a gym
| Study group | Role | What they receive |
|---|---|---|
| Wii Fit Group | Experimental | Received Standard of care and Wii Fit protocol consisted of strength, balance, and aerobic programs that were performed on the Wii Fit balance board (Nintendo Inc., Kyoto, Japan). For muscle strengthening exercise, lunges, single-leg extensions, sideways leg lifts, single leg twists, and rowing squats were performed. For exercise that enhances balancing sense, the soccer heading, ski slalom, penguin, table tilt, and balance bubble games were used. Aerobic games as hula hoop, super hula hoop and basic step. Receives: Other: virtual reality; Other: Standard of care |
| Standard of care group | Other | On discharge from the hospital, patients in the SOC group were given instructions on how to perform physical therapy and occupational therapy exercises after discharge. After education, patients could perform the physical therapy and occupational therapy exercises either at their own home or a gym. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
high mobility assessment tool
used to assess mobility assessment after burn injuries. It is a valid and reliable unidimensional assessment tool which includes nine functional tasks, where 0 = inability to do and 4= able to do extremely well, with a total score of 54. Each Functional task is rated on a five-point performance scale with higher scores indicate a higher level of performance
Measured: at baseline
high mobility assessment tool
used to assess mobility assessment after burn injuries. It is a valid and reliable unidimensional assessment tool which includes nine functional tasks, where 0 = inability to do and 4= able to do extremely well, with a total score of 54. Each Functional task is rated on a five-point performance scale with higher scores indicate a higher level of performance
Measured: after 12 weeks
Lower Limb Functional Index
a valid and reliable patient self-reported questionnaire to assess lower limb function for patients with a burn injury. It is consisted of fifteen general and ten lower-limb specific items that assess the functional status of the patients during the last 2-3 days. The scoring options for the LLFI Items are Yes=1 point, Somewhat= 0.5 point and No= 0 point. The scoring points are added and then multiplied by four for a total score of functional limitation. The total score of the LLFI ranges from 0 (maximum limitation) to 100 (no limitation or normal functional status)
Measured: at baseline
Lower Limb Functional Index
a valid and reliable patient self-reported questionnaire to assess lower limb function for patients with a burn injury. It is consisted of fifteen general and ten lower-limb specific items that assess the functional status of the patients during the last 2-3 days. The scoring options for the LLFI Items are Yes=1 point, Somewhat= 0.5 point and No= 0 point. The scoring points are added and then multiplied by four for a total score of functional limitation. The total score of the LLFI ranges from 0 (maximum limitation) to 100 (no limitation or normal functional status)
Measured: after 12 weeks
Timed-up and go test
used to evaluate functional mobility of the patients that requires both static and dynamic balance. The TUG test is a basic mobility assessment tool which records the time taken to stand up from a chair, walk 3 meters, return and sit down on the chair. The TUG test was performed with a standardized instruction, asking patients to walk as fast as possible during the test. All participants performed the TUG test from a standard chair (seat height of approximately 46 cm) with back support and no arms
Measured: at baseline
Timed-up and go test
used to evaluate functional mobility of the patients that requires both static and dynamic balance. The TUG test is a basic mobility assessment tool which records the time taken to stand up from a chair, walk 3 meters, return and sit down on the chair. The TUG test was performed with a standardized instruction, asking patients to walk as fast as possible during the test. All participants performed the TUG test from a standard chair (seat height of approximately 46 cm) with back support and no arms
Measured: after 12 weeks
Secondary outcomes (6)
The six-minute walk test
used to assess functional exercise capacity of the participants. The 6-MWT was performed in a 30-meters flat corridor according to the American Thoracic Society guidelines. Patients were asked to walk as far as possible in the 30-m corridor during the 6-min period. Standardized verbal encouragement is given to the patients during the 6-MWT. At the end of the test, the walking distance was measured. The predicted values of 6-MWT were calculated according to age and gender
Measured: at baseline
The six-minute walk test
used to assess functional exercise capacity of the participants. The 6-MWT was performed in a 30-meters flat corridor according to the American Thoracic Society guidelines. Patients were asked to walk as far as possible in the 30-m corridor during the 6-min period. Standardized verbal encouragement is given to the patients during the 6-MWT. At the end of the test, the walking distance was measured. The predicted values of 6-MWT were calculated according to age and gender
Measured: after 12 weeks
Isokinetic Muscle Strength Assessment
assessed by A Biodex dynamometer (Biodex Medical System, Shirley, NY, USA). The values of knee flexors and extensors muscle peak torque of dominant leg were measured regardless the location of burns at an angular velocity of 150°/seconds, hip angle of 100° and patient were supported with a securing belt placed over the mid- thigh, pelvis and trunk. Three sub-maximal repetitions were allowed for the patient without any load as a warm-up. The patient then carried out 10 of maximum voluntary muscle contractions continuously without rest and the highest values were recorded for analysis.
Measured: at baseline
Isokinetic Muscle Strength Assessment
assessed by A Biodex dynamometer (Biodex Medical System, Shirley, NY, USA). The values of knee flexors and extensors muscle peak torque of dominant leg were measured regardless the location of burns at an angular velocity of 150°/seconds, hip angle of 100° and patient were supported with a securing belt placed over the mid- thigh, pelvis and trunk. Three sub-maximal repetitions were allowed for the patient without any load as a warm-up. The patient then carried out 10 of maximum voluntary muscle contractions continuously without rest and the highest values were recorded for analysis.
Measured: after 12 weeks
Stability Index
assessed by A Biodex Balance System (Biodex Medical Systems, Shirley, NY) which consists of a movable balance platform that provides 20° surface tilt through 360° range of motion. The platform interfaces with computer software that enables the device to serve as an objective assessment of balance. All measurements were performed at level eight of stability, and the test duration was set at 20 seconds for three successive trials.
Measured: at baseline
Stability Index
assessed by A Biodex Balance System (Biodex Medical Systems, Shirley, NY) which consists of a movable balance platform that provides 20° surface tilt through 360° range of motion. The platform interfaces with computer software that enables the device to serve as an objective assessment of balance. All measurements were performed at level eight of stability, and the test duration was set at 20 seconds for three successive trials.
Measured: after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 May 2016
- Primary completion20 Aug 2019
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Maged Basha, Qassim University
- Investigators
- Maged Basha, Principal investigator, Qassim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677764
- Sponsor's protocol ID
- 2657PT
- Acronym
- adultburn
- Status last verified
- Dec 2020
- First submitted
- 11 Dec 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Publications
Jeschke MG, Chinkes DL, Finnerty CC, Kulp G, Suman OE, Norbury WB, Branski LK, Gauglitz GG, Mlcak RP, Herndon DN. Pathophysiologic response to severe burn injury. Ann Surg. 2008 Sep;248(3):387-401. doi: 10.1097/SLA.0b013e3181856241.
PubMed 18791359Dyster-Aas J, Kildal M, Willebrand M. Return to work and health-related quality of life after burn injury. J Rehabil Med. 2007 Jan;39(1):49-55. doi: 10.2340/16501977-0005.
PubMed 17225038Kim KJ, Heo M. Effects of virtual reality programs on balance in functional ankle instability. J Phys Ther Sci. 2015 Oct;27(10):3097-101. doi: 10.1589/jpts.27.3097. Epub 2015 Oct 30.
PubMed 26644652Basha MA, Abdel-Aal NM, Kamel FAH. Effects of Wii Fit Rehabilitation on Lower Extremity Functional Status in Adults With Severe Burns: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2022 Feb;103(2):289-296. doi: 10.1016/j.apmr.2021.08.020. Epub 2021 Sep 24.
PubMed 34571011
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Wii Fit Training on Lower Limb Burn in Adults
- ClinicalTrials.gov ID
- NCT04677764
- Acronym / sponsor ID
- adultburn / 2657PT
- Conditions
- Burns
- Keywords
- burns, lower limb burns, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 May 2016 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 21 Dec 2020 (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.
To investigate the potential effects of Wii fit rehabilitation programs on functional capacity, mobility, balance and muscle strength in lower limb burn patients after hospital discharge.
Detailed description
The use of virtual reality technology in burn conditions improved joint flexibility and reduced pain associated with physical therapy, dressing changes, and wound debridement. However, the primary concern of burn rehabilitation is not only survival but also maximizing functional outcome and decreasing the time for return to work.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wii Fit Group | Experimental | Other: virtual reality, Other: Standard of careReceived Standard of care and Wii Fit protocol consisted of strength, balance, and aerobic programs that were performed on the Wii Fit balance board (Nintendo Inc., Kyoto, Japan). For muscle strengthening exercise, lunges, single-leg extensions, sideways leg lifts, single leg twists, and rowing squats were performed. For exercise that enhances balancing sense, the soccer heading, ski slalom, penguin, table tilt, and balance bubble games were used. Aerobic games as hula hoop, super hula hoop and basic step. |
| Standard of care group | Other | Other: Standard of careOn discharge from the hospital, patients in the SOC group were given instructions on how to perform physical therapy and occupational therapy exercises after discharge. After education, patients could perform the physical therapy and occupational therapy exercises either at their own home or a gym. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- adult with a deep partial thickness or a full thickness burn in the lower extremities.
- induced by either a scaled or a flame thermal burn.
- total body surface area (TBSA) more than 40%.
- age ranged from 18 to 40 years.
- recent hospital discharge.
Key exclusion criteria (7 listed)
- Infection.
- Diabetes.
- inhalation injury.
- Fracture.
- degenerative joint diseases of the lower extremities.
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 realityAlso: interactive video gamesWii Fit balance board (Nintendo Inc., Kyoto, Japan). | Other | Wii Fit Group |
| Standard of careAlso: routine physical therapy protocolphysical therapy and occupational therapy exercises either at their own home or a gym | Other | Standard of care group, Wii Fit Group |
Primary outcome
high mobility assessment tool
Time frame: at baseline
used to assess mobility assessment after burn injuries. It is a valid and reliable unidimensional assessment tool which includes nine functional tasks, where 0 = inability to do and 4= able to do extremely well, with a total score of 54. Each Functional task is rated on a five-point performance scale with higher scores indicate a higher level of performance
high mobility assessment tool
Time frame: after 12 weeks
used to assess mobility assessment after burn injuries. It is a valid and reliable unidimensional assessment tool which includes nine functional tasks, where 0 = inability to do and 4= able to do extremely well, with a total score of 54. Each Functional task is rated on a five-point performance scale with higher scores indicate a higher level of performance
Lower Limb Functional Index
Time frame: at baseline
a valid and reliable patient self-reported questionnaire to assess lower limb function for patients with a burn injury. It is consisted of fifteen general and ten lower-limb specific items that assess the functional status of the patients during the last 2-3 days. The scoring options for the LLFI Items are Yes=1 point, Somewhat= 0.5 point and No= 0 point. The scoring points are added and then multiplied by four for a total score of functional limitation. The total score of the LLFI ranges from 0 (maximum limitation) to 100 (no limitation or normal functional status)
Lower Limb Functional Index
Time frame: after 12 weeks
a valid and reliable patient self-reported questionnaire to assess lower limb function for patients with a burn injury. It is consisted of fifteen general and ten lower-limb specific items that assess the functional status of the patients during the last 2-3 days. The scoring options for the LLFI Items are Yes=1 point, Somewhat= 0.5 point and No= 0 point. The scoring points are added and then multiplied by four for a total score of functional limitation. The total score of the LLFI ranges from 0 (maximum limitation) to 100 (no limitation or normal functional status)
Timed-up and go test
Time frame: at baseline
used to evaluate functional mobility of the patients that requires both static and dynamic balance. The TUG test is a basic mobility assessment tool which records the time taken to stand up from a chair, walk 3 meters, return and sit down on the chair. The TUG test was performed with a standardized instruction, asking patients to walk as fast as possible during the test. All participants performed the TUG test from a standard chair (seat height of approximately 46 cm) with back support and no arms
Timed-up and go test
Time frame: after 12 weeks
used to evaluate functional mobility of the patients that requires both static and dynamic balance. The TUG test is a basic mobility assessment tool which records the time taken to stand up from a chair, walk 3 meters, return and sit down on the chair. The TUG test was performed with a standardized instruction, asking patients to walk as fast as possible during the test. All participants performed the TUG test from a standard chair (seat height of approximately 46 cm) with back support and no arms
6 secondary outcomes
The six-minute walk test
Time frame: at baseline
The six-minute walk test
Time frame: after 12 weeks
Isokinetic Muscle Strength Assessment
Time frame: at baseline
Isokinetic Muscle Strength Assessment
Time frame: after 12 weeks
Stability Index
Time frame: at baseline
Stability Index
Time frame: after 12 weeks
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 21 Dec 2020.
- Results publication: PubMed 18791359Jeschke MG, Chinkes DL, Finnerty CC, Kulp G, Suman OE, Norbury WB, Branski LK, Gauglitz GG, Mlcak RP, Herndon DN. Pathophysiologic response to severe burn injury. Ann Surg. 2008 Sep;248(3):387-401. doi: 10.1097/SLA.0b013e3181856241.
- Results publication: PubMed 17225038Dyster-Aas J, Kildal M, Willebrand M. Return to work and health-related quality of life after burn injury. J Rehabil Med. 2007 Jan;39(1):49-55. doi: 10.2340/16501977-0005.
- Results publication: PubMed 26644652Kim KJ, Heo M. Effects of virtual reality programs on balance in functional ankle instability. J Phys Ther Sci. 2015 Oct;27(10):3097-101. doi: 10.1589/jpts.27.3097. Epub 2015 Oct 30.
- Derived from this study: PubMed 34571011Basha MA, Abdel-Aal NM, Kamel FAH. Effects of Wii Fit Rehabilitation on Lower Extremity Functional Status in Adults With Severe Burns: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2022 Feb;103(2):289-296. doi: 10.1016/j.apmr.2021.08.020. Epub 2021 Sep 24.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable 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.
Maged Basha principal investigator
Qassim University
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality in people with Burns, run by Qassim University.
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 5 inclusion and 7 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 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
high mobility assessment tool (time frame: at baseline). The study lists 6 primary outcomes in all. 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 NCT04677764, which also lists 4 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 21 Dec 2020.