Reallocating Rehabilitation Time to Wii Fit or Pilates After Lower-Limb Burn Injury

Reallocating Rehabilitation Time to Wii Fit or Pilates After Lower-Limb Burn Injury: A Randomized Controlled Trial

This randomized controlled trial will evaluate whether reallocating part of a fixed-duration supervised rehabilitation session to Wii Fit or Pilates will improve functional outcomes in adults with healed lower-extremity burns. Participants will be randomly assigned to Wii Fit, Pilates, or conventional rehabilitation and will receive 60-minute supervised sessions three times weekly for 12 weeks. Walking capacity, postural stability, functional mobility, and quadriceps muscle performance will be assessed at baseline, after the 12-week intervention, and 12 weeks after completion of supervised rehabilitation. The study will compare these time-matched rehabilitation approaches and will assess the persistence of functional changes during the subsequent follow-up period.

Study Overview

• Status: Completed
• Conditions: Burns; Muscle Weakness; Functional Performance; Exercises
• Intervention / Treatment: Other: Standard physical therapy program; Other: Pilates exercises program; Other: Wii fit exercises program

Detailed Description

Burn injuries involving the lower extremities can result in persistent limitations in walking capacity, balance, functional mobility, and lower-limb muscle performance. Rehabilitation commonly includes gait training, strengthening, balance exercises, and functional activities; however, the optimal allocation of a limited supervised rehabilitation session among different exercise approaches remains uncertain.

This randomized controlled trial will evaluate the effects of reallocating part of a fixed-duration supervised rehabilitation session to either Wii Fit-based exercise or Pilates in adults with healed second-degree thermal burns of the lower extremities.

Participants will be randomly allocated in a 1:1:1 ratio to three parallel groups: Wii Fit rehabilitation, Pilates rehabilitation, or conventional rehabilitation. All groups will receive supervised rehabilitation three times per week for 12 weeks, with an intended session duration of 60 minutes. In the Wii Fit and Pilates groups, approximately 30 minutes of selected conventional rehabilitation content will be replaced by the corresponding intervention rather than added to the total rehabilitation time. The conventional rehabilitation group will receive the standard 60-minute rehabilitation program.

The Wii Fit intervention will incorporate balance, weight-shifting, single-leg balance, step-based, and light aerobic game activities using the Nintendo Wii Fit system and Balance Board. The Pilates intervention will consist of mat-based exercises emphasizing trunk control, postural alignment, breathing, movement precision, and progressive body-weight or elastic-band resistance. Exercise progression will be individualized according to a standardized treatment manual, with progression based on technical performance, tolerance, and absence of clinically relevant symptom or skin/scar exacerbation.

Functional outcomes will be assessed at baseline, immediately after the 12-week supervised intervention, and 12 weeks after completion of supervised treatment. Outcomes will include walking capacity measured by the 6-minute walk test, postural stability measured by the Overall Stability Index, functional mobility measured by the Timed Up and Go test, and quadriceps muscle performance measured by isokinetic peak torque.

The study will also examine whether functional gains observed following the supervised rehabilitation period will be maintained during the subsequent 12-week observational follow-up period.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Shaimaa Mohamed Ahmed El Sayeh
  • New Cairo
    • Cairo, New Cairo, Egypt, 02
      • Shaimaa Mohamed Ahmed El Sayeh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male participants aged 25 to 40 years.
• Healed second-degree thermal burns confined to the lower extremities.
• Medical clearance to participate in the prescribed rehabilitation program.
• Ability to understand and follow the study instructions and perform the required functional assessments.

Exclusion Criteria:

• Cardiovascular or neurological disorders that could limit participation in the exercise program or affect outcome assessment.
• Burns involving the plantar surface of the foot or exposed digital tendons.
• Lower-limb amputation.
• Body mass index greater than 30 kg/m².
• Participation in another structured exercise or rehabilitation program during the study period.

Per-Protocol Analysis Criterion:

• Participants attending fewer than 80% of the scheduled supervised rehabilitation sessions will be excluded from the per-protocol analysis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wii fit exercises group; Participants will receive a 60-minute supervised rehabilitation session, 3 sessions per week for 12 weeks. Approximately 30 minutes of selected conventional rehabilitation content will be replaced by Wii Fit-based exercises, rather than added to the total rehabilitation time. The Wii Fit program will include weight-shifting, single-leg balance, step-based, and light aerobic game activities using the Nintendo Wii Fit system and Balance Board. The remaining approximately 30 minutes will consist of conventional rehabilitation components including gait and mobility training, strengthening-focused activities, and cool-down/stretching.	Other: Standard physical therapy program; All patients will receive the standard physical therapy program consisting of 45 minutes per session of a supervised and individualized exercise program for three sessions per week for eight weeks which will include: Stretching exercises for lower limb muscles, each stretch will be maintained for 45 seconds, 3 repetitions, strengthening exercises for lower limb muscles starting from 50 to 60% of 1 repetition maximum and the intensity will be increased gradually until 80 to 85 % through the treatments weeks.; Other: Wii fit exercises program; Participants will receive a 60-minute supervised rehabilitation session, 3 sessions per week for 12 weeks. Approximately 30 minutes of selected conventional rehabilitation content will be replaced by Wii Fit-based exercises rather than added to the total session duration. The Wii Fit program will include weight-shifting, single-leg balance, step-based activities, and light aerobic game-based exercises using the Nintendo Wii Fit system and Balance Board. The remaining approximately 30 minutes will consist of conventional rehabilitation components, including gait and mobility training, strengthening-focused activities, and cool-down/stretching.
Experimental: Pilates exercises group; Participants will receive a 60-minute supervised rehabilitation session, 3 sessions per week for 12 weeks. Approximately 30 minutes of selected conventional rehabilitation content will be replaced by Pilates exercises rather than added to the total session duration. The Pilates program will consist of mat-based exercises emphasizing trunk control, postural alignment, breathing, movement precision, and progressive body-weight or elastic-band resistance. The remaining approximately 30 minutes will consist of conventional rehabilitation components, including gait and mobility training, strengthening-focused activities, and cool-down/stretching.	Other: Standard physical therapy program; All patients will receive the standard physical therapy program consisting of 45 minutes per session of a supervised and individualized exercise program for three sessions per week for eight weeks which will include: Stretching exercises for lower limb muscles, each stretch will be maintained for 45 seconds, 3 repetitions, strengthening exercises for lower limb muscles starting from 50 to 60% of 1 repetition maximum and the intensity will be increased gradually until 80 to 85 % through the treatments weeks.; Other: Pilates exercises program; Selected pilates exercises for balance training and lower limb strengthening: Articulating bridge, Spine stretch, Single leg stretch, Double leg stretch, Criss-cross, One leg kick, Side kick, Hip twist, and Standing footwork for 30 minutes, 10 repetitions each. In addition to the warming up and the cooling down exercises before and after the pilates exercises, 10 minutes each in the form of a range of motion exercises and stretching, and deep friction massage for scar management.
Active Comparator: Standard physical therapy group; Participants will receive a 60-minute supervised conventional rehabilitation program, 3 sessions per week for 12 weeks. The program will include gait and mobility training, lower-limb strengthening exercises, core stabilization exercises, balance training, and cool-down/stretching exercises. Exercise progression will be individualized according to the study treatment manual and participant tolerance.	Other: Standard physical therapy program; All patients will receive the standard physical therapy program consisting of 45 minutes per session of a supervised and individualized exercise program for three sessions per week for eight weeks which will include: Stretching exercises for lower limb muscles, each stretch will be maintained for 45 seconds, 3 repetitions, strengthening exercises for lower limb muscles starting from 50 to 60% of 1 repetition maximum and the intensity will be increased gradually until 80 to 85 % through the treatments weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in walking capacity measured by the 6-minute walk test (6MWT).	The 6-minute walk test will be performed in a 30-meter flat corridor according to standardized American Thoracic Society procedures. Participants will be instructed to walk as far as possible for 6 minutes, with standardized verbal encouragement provided according to the test protocol. The total distance walked, measured in meters, will be recorded. The primary endpoint will be the change from baseline to the end of the 12-week supervised intervention. Walking capacity will also be reassessed at 24 weeks to describe the persistence of changes during the 12-week observational follow-up after completion of supervised rehabilitation.	Change from baseline to 12 weeks after initiation of the intervention; additional follow-up assessment at 24 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Overall Stability Index (OSI).	Postural stability will be assessed using the Biodex Balance System SD (Biodex Medical Systems, Shirley, NY, USA). The Overall Stability Index (OSI) will be recorded as an objective measure of postural stability, with lower scores indicating better stability.	Change from baseline to 12 weeks after initiation of the intervention; additional assessment at 24 weeks.
Change in functional mobility measured by the Timed Up and Go (TUG) test.	Functional mobility will be assessed using the Timed Up and Go test. Participants will be instructed to rise from a chair, walk 3 meters, turn, return to the chair, and sit down. The time required to complete the task will be recorded in seconds, with lower values indicating better functional mobility.	Change from baseline to 12 weeks after initiation of the intervention; additional assessment at 24 weeks.
Change in isokinetic quadriceps peak torque.	Quadriceps muscle performance will be assessed using a Biodex System 3 Pro isokinetic dynamometer (Biodex Medical Systems, Shirley, NY, USA). Peak torque of the quadriceps will be measured at an angular velocity of 60°/s using standardized positioning and stabilization procedures. The peak torque value will be recorded for analysis.	Change from baseline to 12 weeks after initiation of the intervention; additional assessment at 24 weeks.

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Shaimaa M. A. Elsayeh, Associate Professor at Faculty of Physical Therapy, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2024
• Primary Completion (Actual): April 1, 2026
• Study Completion (Actual): May 11, 2026

Study Registration Dates

• First Submitted: October 7, 2023
• First Submitted That Met QC Criteria: October 7, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 16, 2026
• Last Update Submitted That Met QC Criteria: September 12, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Walking capacity; Pilates; Virtual reality; balance; Quadriceps strength; Wii Fit; Burn rehabilitation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Manifestations; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Muscle Weakness; Burns; Motor Activity
• Other Study ID Numbers: P.T.REC/012/004387

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No