Cycle to Fun - 'Exergames' for Inpatient Rehabilitation for Children/Youth With CP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Percentage of participants who complete the Faces Pain Scale-Revised at baseline and at the end of the third week of the intervention phase [Feasibility]
研究概览
简要总结
This study is designed to evaluate the feasibility and primary responses of a 3-week exergaming cycling program called Liberi Exergames for pediatric inpatients with cerebral palsy who are recovering from orthopedic surgery. This study involves the use of multiplayer exercise video games or 'exergames' that incorporate an avatar powered by pedalling a recumbent stationary bicycle. The Liberi suite of exergames contains six mini-games, including a combination of cooperative games, competitive games and individual games designed to be fast-paced, action-oriented, and enjoyable for youth with special needs. Standardized questionnaires and assessments investigating post-operative pain, gross motor function, quality of life, and study engagement are also administered. Five participants will engage in 'exergaming' sessions every weekday for 3 weeks, and five participants will only complete the assessments and questionnaires. All participants will receive the standard of care physiotherapy.
详细描述
As children with ambulatory CP become teenagers, they experience a decrease in their physical function and mobility. Many children/youth with CP develop contractures (i.e., shortening of their muscles) and bony deformities (e.g., hip subluxation) that require lower limb orthopedic surgery at some point between the ages of 7-16 years. Post-operatively this is followed by intensive rehabilitation to regain motor function. These youths often engage in sedentary activities and have low motivation to actively participate in physiotherapy thereby limiting their mobility, fitness, and overall well-being. Furthermore, pain is common during the post-surgical recovery period and is aggravated by muscle spasms.
Cycling is often incorporated into post-orthopedic rehabilitation programs in adults and has shown to reduce muscle spasms and improve range of motion post-hip replacement surgery. However, studies have yet to look at the role of cycling post-orthopedic surgery in youth with CP. Exercise video games or 'exergames' are a novel approach to engage youth with special needs in physical exercise and social interaction with their peers. To date the investigator's team of rehabilitation and computer scientists has developed an accessible and functional recumbent bicycling-based exergaming station, called the Liberi Exergames. These multiplayer exergames are designed to be fast-paced, action-oriented and enjoyable for youth with special needs and have been developed specifically for youth with CP.
The purpose of this case comparison study is to compare exergaming and standard physiotherapy to standard physiotherapy alone, in children with CP who are recovering from orthopedic surgery in an inpatient setting. This study is designed to evaluate the feasibility and primary responses to cycling with the Liberi Exergames. The primary outcomes are recruitment capability and acceptability as well as satisfaction of the intervention. Secondary outcomes are pain, health-related quality of life, and lower limb passive range of motion.
The first five participants will be recruited into the 'comparison' group and will participate in all study procedures except for the 'Exergaming' sessions. This will be followed by recruitment of 5 participants into the 'case' group, who will participate in the 'Exergaming' sessions as well as completing standardized assessments and questionnaires. All participants will receive physiotherapy as per standard of care.
Children/youth in the case group will play the Liberi Exergames for approximately 30 minutes per session in the afternoon, 5 days a week for three weeks. With the appropriate warm up/cool down, plus transfer on and off the unit, the total time for each training session will be approximately 45 minutes. The exergames will be supervised by a therapeutic recreation specialist and research staff, with transfers on and off the bike supervised by physiotherapy and/or nursing staff. The participants will not start the 3 week Exergame sessions until after they have started weight-bearing (i.e. for children who have received soft-tissue releases this is anticipated immediately post-operatively; for children who have had bony procedures this is anticipated at 4 weeks post-operatively).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children/youth diagnosed with CP admitted to Holland Bloorview Kids Rehabilitation Hospital for inpatient rehabilitation following lower extremity orthopedic surgery
- •Between 7 to 18 years of age
- •Pre-operative Gross Motor Functional Classification Scale (GMFCS) level I - III
- •Willingness and ability to operate a hand-held controller and pedal on the Liberi Exergames system
- •Ability to self-report on the Faces Pain Scale-Revised (FPS-R)
- •Documentation of informed consent by participant and/or representative and/or caregiver
排除标准
- •Presence of unmanaged medical conditions (like exercise-induced asthma, heart condition, and uncontrolled seizures) that might prevent ability to train with the Liberi Exergames system
结局指标
主要结局
Percentage of participants who complete the Faces Pain Scale-Revised at baseline and at the end of the third week of the intervention phase [Feasibility]
时间窗: End of week 3 of the intervention phase
Good adherence with the assessments and outcome measures will be demonstrated if 100% of participants complete the FPS-R obtained at baseline and at the end of the third week of the intervention phase.
Percentage of eligible participants recruited [Feasibility]
时间窗: 4 months
Patients must meet all eligibility criteria in order to be included in the analysis of this outcome measure. A higher proportion of eligible patients recruited is considered to be a better outcome.
Percentage of participants who complete at least 12 of 15 Liberi Exergame Sessions [Feasibility]
时间窗: End of week 3 of the intervention phase
Adherence with the intervention protocol will aim for completion of \>12 sessions out of 15 30-minute sessions administered over 3 weeks for each participant in the case group.
次要结局
- Patient Reported Outcome Measurement Information Systems Pediatric Pain Interference Scale (PROMIS-PI)(Baseline, end of weeks 1, 2, and 3 of the intervention phase)
- KIDSCREEN-27(Baseline, end of week 3 of the intervention phase)
- Faces Pain Scale-Revised (FPS-R)(Baseline, end of weeks 1, 2, and 3 of the intervention phase)
- Change in Lower Limb Passive Range of Motion (PROM)(Baseline, end of week 3 of the intervention phase)
- Pediatric Rehabilitation Intervention Measure of Engagement-Observation (PRIME-O)(End of week 2 of the intervention phase)
- Self-Reported Experiences of Activity Settings (SEAS)(End of week 2 of the intervention phase)
