Virtual Reality in Lower Limb Adult Burn

NCT ID: NCT04677764

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2019-08-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Burns

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

burns lower limb burns virtual reality

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
A blinded author to group allocation collected the outcome measures at baseline and after 12 weeks of intervention period.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

virtual reality

Intervention Type OTHER

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

Standard of care

Intervention Type OTHER

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

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.

Group Type OTHER

Standard of care

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

virtual reality

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

Intervention Type OTHER

Standard of care

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

interactive video games routine physical therapy protocol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role collaborator

Qassim University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Maged Basha

Assistant Professor, Department of Physical Therapy, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maged Basha

Role: PRINCIPAL_INVESTIGATOR

Qassim University

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 18791359 (View on PubMed)

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.

Reference Type RESULT
PMID: 17225038 (View on PubMed)

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.

Reference Type RESULT
PMID: 26644652 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34571011 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2657PT

Identifier Type: -

Identifier Source: org_study_id