BurnsNCT06081504
Reallocating Rehabilitation Time to Wii Fit or Pilates After Lower-Limb Burn Injury
A study testing Wii fit exercises program, Pilates exercises program and Standard physical therapy program in people with Burns and Muscle Weakness, run by Cairo University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Burns, Muscle Weakness, Exercises
- What is being tested?
- Wii fit exercises program, Pilates exercises program and Standard physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 May 2024to 11 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Shaimaa Mohamed Ahmed El Sayeh
Cairo, New Cairo, 02
Shaimaa Mohamed Ahmed El Sayeh
Cairo, 02
About this study
Official title: 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.
Read the 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.
- Conditions
- Burns, Muscle Weakness, Exercises, Functional Performance
- Being tested
- Wii fit exercises program, Pilates exercises program, Standard physical therapy program
- Keywords
- balance, Burn rehabilitation, Pilates, Quadriceps strength, Randomized controlled trial, Virtual reality, Walking capacity, Wii Fit
- Medical subject headings
- Burns, Muscle Weakness, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wii fit exercises programOther
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.
Pilates exercises programOther
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.
Standard physical therapy programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Wii fit exercises group | Experimental | 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. Receives: Other: Wii fit exercises program; Other: Standard physical therapy program |
| Pilates exercises group | Experimental | 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. Receives: Other: Pilates exercises program; Other: Standard physical therapy program |
| Standard physical therapy group | Active comparator | 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. Receives: Other: Standard physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 12 weeks after initiation of the intervention; additional follow-up assessment at 24 weeks.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to 12 weeks after initiation of the intervention; additional assessment at 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start10 May 2024
- Primary completion1 Apr 2026
- Study completion11 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohamed Ahmed Elsayeh, Cairo University
- Investigators
- Shaimaa M. A. Elsayeh, Principal investigator, Associate Professor at Faculty of Physical Therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081504
- Sponsor's protocol ID
- P.T.REC/012/004387
- Status last verified
- Sep 2026
- First submitted
- 7 Oct 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reallocating Rehabilitation Time to Wii Fit or Pilates After Lower-Limb Burn Injury: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06081504
- Acronym / sponsor ID
- P.T.REC/012/004387
- Conditions
- Burns, Muscle Weakness, Exercises, Functional Performance
- Keywords
- balance, Burn rehabilitation, Pilates, Quadriceps strength, Randomized controlled trial, Virtual reality, Walking capacity, Wii Fit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 11 May 2026 (actual)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Wii fit exercises group | Experimental | Other: Wii fit exercises program, Other: Standard physical therapy programParticipants 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. |
| Pilates exercises group | Experimental | Other: Pilates exercises program, Other: Standard physical therapy programParticipants 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. |
| Standard physical therapy group | Active comparator | Other: Standard physical therapy programParticipants 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. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wii fit exercises programParticipants 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. | Other | Wii fit exercises group |
| Pilates exercises programSelected 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. | Other | Pilates exercises group |
| Standard physical therapy programAll 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 group, Standard physical therapy group, Wii fit exercises group |
Primary outcome
Change in walking capacity measured by the 6-minute walk test (6MWT).
Time frame: 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.
3 secondary outcomes
Change in Overall Stability Index (OSI).
Time frame: 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.
Time frame: Change from baseline to 12 weeks after initiation of the intervention; additional assessment at 24 weeks.
Change in isokinetic quadriceps peak torque.
Time frame: Change from baseline to 12 weeks after initiation of the intervention; additional assessment at 24 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaimaa M. A. Elsayeh principal investigator
Associate Professor at Faculty of Physical Therapy, Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wii fit exercises program, Pilates exercises program and Standard physical therapy program in people with Burns and Muscle Weakness, run by Cairo University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in walking capacity measured by the 6-minute walk test (6MWT). (time frame: Change from baseline to 12 weeks after initiation of the intervention; additional follow-up assessment at 24 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.