Virtual Reality in Lower Limb Adult Burn

NCT04677764 | Completed

• 1 other identifier: 2657PT
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Burns

Keywords

burns; lower limb burns; virtual reality

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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)

  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)

  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

  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

  after 12 weeks

Secondary Outcomes (6)

• The six-minute walk test

  at baseline

• The six-minute walk test

  after 12 weeks

• Isokinetic Muscle Strength Assessment

  at baseline

• Isokinetic Muscle Strength Assessment

  after 12 weeks

• Stability Index

  at baseline

Study Arms (2)

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.

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.

Other: Standard of care

Interventions

virtual reality OTHER

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

Also known as: interactive video games

Wii Fit Group

Standard of care OTHER

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

Also known as: routine physical therapy protocol

Standard of care group; Wii Fit Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Qassim University: lead
• Cairo University: collaborator

Related Publications (4)

• 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.

  PMID: 18791359 RESULT

• 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.

  PMID: 17225038 RESULT

• 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.

  PMID: 26644652 RESULT

• 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.

  PMID: 34571011 DERIVED

MeSH Terms

Conditions

Burns

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Maged Basha

  Qassim University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A blinded author to group allocation collected the outcome measures at baseline and after 12 weeks of intervention period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Physical Therapy, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah.

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 21, 2020
• Study Start: May 1, 2016
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after publication
• 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.