Reallocating Rehabilitation Time to Wii Fit or Pilates After Lower-Limb Burn Injury: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Dynamic balance score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Wii fit exercises program (Other)
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.
干预措施: Standard physical therapy program (Other)
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.
干预措施: Pilates exercises program (Other)
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.
干预措施: Standard physical therapy program (Other)
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.
干预措施: Standard physical therapy program (Other)
结局指标
主要结局
Dynamic balance score
时间窗: Change from baseline at twelve weeks after the intervention
The dynamic balance score will be measured by the Biodex Balance System (Biodex Medical System, Shirley, NY, USA). The Biodex Balance System is a valid and reliable method to assess dynamic balance. A Biodex Balance System (Biodex Medical Systems, Shirley, NY) consists of a movable balance platform that provides a 20° surface tilt through a 360° range of motion. The platform interfaces with computer software that enables the device to serve as an objective assessment of balance. All measurements were performed at level eight of stability, and the test duration was set at 20 seconds for three successive trials
Isokinetic Muscle Strength Assessment
时间窗: Change from baseline at twelve weeks after the intervention
Isokinetic Muscle Strength Assessment will be assessed by A Biodex dynamometer (Biodex Medical System, Shirley, NY, USA). The values of knee flexors and extensors muscle peak torque of dominant leg were measured regardless the location of burns at an angular velocity of 150°/seconds, hip angle of 100° and patient were supported with a securing belt placed over the mid- thigh, pelvis and trunk. Three sub-maximal repetitions were allowed for the patient without any load as a warm-up. The patient then carried out 10 of maximum voluntary muscle contractions continuously without rest and the highest values were recorded for analysis.
Change in walking capacity measured by the 6-minute walk test (6MWT).
时间窗: 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.
次要结局
- Functional exercise capacity(Change from baseline at twelve weeks after the intervention)
- Change in Overall Stability Index (OSI).(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.(Change from baseline to 12 weeks after initiation of the intervention; additional assessment at 24 weeks.)
- Change in isokinetic quadriceps peak torque.(Change from baseline to 12 weeks after initiation of the intervention; additional assessment at 24 weeks.)
研究者
Shaimaa Mohamed Ahmed Elsayeh
Associate Professor of Physical Therapy
Cairo University