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Virtual Reality in Lower Limb Adult Burn (adultburn)

Primary Purpose

Burns

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
virtual reality
Standard of care
Sponsored by
Qassim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring burns, lower limb burns, virtual reality

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Wii Fit Group

    Standard of care group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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
    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
    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)
    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)
    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
    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

    Secondary Outcome Measures

    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
    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
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    December 11, 2020
    Last Updated
    December 16, 2020
    Sponsor
    Qassim University
    Collaborators
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04677764
    Brief Title
    Virtual Reality in Lower Limb Adult Burn
    Acronym
    adultburn
    Official Title
    Efficacy of Wii Fit Training on Lower Limb Burn in Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2016 (Actual)
    Primary Completion Date
    August 20, 2019 (Actual)
    Study Completion Date
    August 20, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Qassim University
    Collaborators
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Burns
    Keywords
    burns, lower limb burns, virtual reality

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    A blinded author to group allocation collected the outcome measures at baseline and after 12 weeks of intervention period.
    Allocation
    Randomized
    Enrollment
    34 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Wii Fit Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Standard of care group
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    virtual reality
    Other Intervention Name(s)
    interactive video games
    Intervention Description
    Wii Fit balance board (Nintendo Inc., Kyoto, Japan).
    Intervention Type
    Other
    Intervention Name(s)
    Standard of care
    Other Intervention Name(s)
    routine physical therapy protocol
    Intervention Description
    physical therapy and occupational therapy exercises either at their own home or a gym
    Primary Outcome Measure Information:
    Title
    high mobility assessment tool
    Description
    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
    Time Frame
    at baseline
    Title
    high mobility assessment tool
    Description
    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
    Time Frame
    after 12 weeks
    Title
    Lower Limb Functional Index
    Description
    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)
    Time Frame
    at baseline
    Title
    Lower Limb Functional Index
    Description
    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)
    Time Frame
    after 12 weeks
    Title
    Timed-up and go test
    Description
    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
    Time Frame
    at baseline
    Title
    Timed-up and go test
    Description
    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
    Time Frame
    after 12 weeks
    Secondary Outcome Measure Information:
    Title
    The six-minute walk test
    Description
    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
    Time Frame
    at baseline
    Title
    The six-minute walk test
    Description
    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
    Time Frame
    after 12 weeks
    Title
    Isokinetic Muscle Strength Assessment
    Description
    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.
    Time Frame
    at baseline
    Title
    Isokinetic Muscle Strength Assessment
    Description
    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.
    Time Frame
    after 12 weeks
    Title
    Stability Index
    Description
    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.
    Time Frame
    at baseline
    Title
    Stability Index
    Description
    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.
    Time Frame
    after 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maged Basha
    Organizational Affiliation
    Qassim University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
    IPD Sharing Time Frame
    6 months after publication
    IPD Sharing Access Criteria
    IPD will be available upon reasonable request by email from the main author after revising the requester qualification relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
    Citations:
    PubMed Identifier
    18791359
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    17225038
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    26644652
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    34571011
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Virtual Reality in Lower Limb Adult Burn

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