Virtual Reality in Lower Limb Adult Burn (adultburn)
Efficacy of Wii Fit Training on Lower Limb Burn in Adults
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Infection.
- Diabetes.
- inhalation injury.
- Fracture.
- degenerative joint diseases of the lower extremities.
- peripheral nerve diseases.
- Pre-established psychologically and physically disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Wii Fit Group
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.
|
Wii Fit balance board (Nintendo Inc., Kyoto, Japan).
Other Names:
physical therapy and occupational therapy exercises either at their own home or a gym
Other Names:
|
|
Other: Standard of care group
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.
|
physical therapy and occupational therapy exercises either at their own home or a gym
Other Names:
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
at baseline
|
|
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
|
after 12 weeks
|
|
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)
|
at baseline
|
|
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)
|
after 12 weeks
|
|
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
|
at baseline
|
|
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
|
after 12 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The six-minute walk test
Time Frame: at baseline
|
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
|
at baseline
|
|
The six-minute walk test
Time Frame: after 12 weeks
|
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
|
after 12 weeks
|
|
Isokinetic Muscle Strength Assessment
Time Frame: at baseline
|
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.
|
at baseline
|
|
Isokinetic Muscle Strength Assessment
Time Frame: after 12 weeks
|
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.
|
after 12 weeks
|
|
Stability Index
Time Frame: at baseline
|
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.
|
at baseline
|
|
Stability Index
Time Frame: after 12 weeks
|
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.
|
after 12 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Maged Basha, Qassim University
Publications and helpful links
General 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.
- Dyster-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.
- Kim 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.
- Basha 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.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2657PT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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