Burns, Muscle Weakness, Exercises, Functional Performance
Conditions
Keywords
balance, Burn rehabilitation, Pilates, Quadriceps strength, Randomized controlled trial, Virtual reality, Walking capacity, Wii Fit
Brief summary
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.
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.
Interventions
OTHERWii 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.
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.
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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Outcome assessors will be blinded to participants' group assignments and will not be involved in delivering the rehabilitation interventions. Participants and treating therapists will not be blinded because the nature of the Wii Fit, Pilates, and conventional rehabilitation interventions will make treatment allocation apparent.
Intervention model description
Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: Wii Fit rehabilitation, Pilates rehabilitation, or conventional rehabilitation. Each group will receive supervised rehabilitation sessions for 60 minutes, three times per week for 12 weeks. The Wii Fit and Pilates groups will receive their respective intervention by replacing approximately 30 minutes of selected conventional rehabilitation content, while the conventional rehabilitation group will receive the standard rehabilitation program.
Eligibility
Sex/Gender
ALL
Age
25 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in walking capacity measured by the 6-minute walk test (6MWT). | Change from baseline to 12 weeks after initiation of the intervention; additional follow-up assessment at 24 weeks. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Overall Stability Index (OSI). | Change from baseline to 12 weeks after initiation of the intervention; additional assessment at 24 weeks. | 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 in functional mobility measured by the Timed Up and Go (TUG) test. | Change from baseline to 12 weeks after initiation of the intervention; additional assessment at 24 weeks. | 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 in isokinetic quadriceps peak torque. | Change from baseline to 12 weeks after initiation of the intervention; additional assessment at 24 weeks. | 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. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORShaimaa M. A. Elsayeh
Associate Professor at Faculty of Physical Therapy, Cairo University
Outcome results
None listed