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CompletedNCT04677764adultburnUpdated Dec 21, 2020

Virtual Reality in Lower Limb Adult Burn

An interventional study of virtual reality and Standard of care in Burns, sponsored by Qassim University. Completed. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-12-21.

Sponsored by Qassim University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 7 months after the study started (first participant enrolled May 2016, registered Dec 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Burns

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Keywords

  • burns
  • lower limb burns
  • virtual reality
03

In context

Burns

719 studies on the registry are indexed under Burns; 145 are open to participants now.

This study's enrollment of 34 is below the median of 40 across 524 interventional studies indexed under Burns.

Browse Burns studies →

Lead sponsor

Qassim University is the lead sponsor of 48 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Infection.
  • Diabetes.
  • inhalation injury.
  • Fracture.
  • degenerative joint diseases of the lower extremities.
  • peripheral nerve diseases.
  • Pre-established psychologically and physically disorders.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • 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.

    Other: virtual reality · Other: Standard of care

  • 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.

    Other: Standard of care

Interventions

  • Othervirtual reality

    Wii Fit balance board (Nintendo Inc., Kyoto, Japan).

    Also known as: interactive video games

  • OtherStandard of care

    physical therapy and occupational therapy exercises either at their own home or a gym

    Also known as: routine physical therapy protocol

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: at baseline

  2. 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

    Time frame: after 12 weeks

  3. 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)

    Time frame: at baseline

  4. 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)

    Time frame: after 12 weeks

  5. 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

    Time frame: at baseline

  6. 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

    Time frame: after 12 weeks

Secondary outcomes

  1. 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

    Time frame: at baseline

  2. 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

    Time frame: after 12 weeks

  3. 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.

    Time frame: at baseline

  4. 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.

    Time frame: after 12 weeks

  5. 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.

    Time frame: at baseline

  6. 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.

    Time frame: after 12 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

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 18791359 ↗
  • 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. PubMed 17225038 ↗
  • 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. PubMed 26644652 ↗
  • 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. PubMed 34571011 ↗

Individual participant data

Plan to share: Yes — The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Supporting information: Study protocol

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04677764
Lead sponsor
Qassim University
Collaborators
Cairo University
Responsible party
Maged Basha (Assistant Professor, Department of Physical Therapy, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah., Qassim University) — Principal investigator
First posted
Dec 21, 2020
Start date
May 1, 2016
Primary completion
Aug 20, 2019
Completion
Aug 20, 2019
Last update
Dec 21, 2020

Study contacts

Maged Basha
principal investigator · Qassim University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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