Video Gaming for Home-Based Rehabilitation: Feasibility for Children With Hemiplegic Cerebral Palsy Living in Costa Rica
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Change in Canadian Occupational Performance Measure (COPM)
研究概览
简要总结
Economic and geographic barriers can limit access to rehabilitation therapies for children with cerebral palsy (CP). These barriers are magnified in developing countries like Costa Rica, where 43% of children with disabilities do not have access to basic health services. To address this accessibility gap, effective and engaging approaches are needed to motivate and support children in practicing motor therapies at home.
Bootle Blast (BB) is a low-cost, movement-tracking video game that encourages upper limb (UL) exercises at home. BB is mixed-reality; using real-life objects (e.g., toys) in gameplay to target fine motor skills. It is customizable to diverse abilities and therapy goals. BB applies best practices in video game design, theories of motivation and motor learning, to optimize engagement and clinical effectiveness.
This mixed-methods study will assess the feasibility of a family-centred BB home intervention among children with hemiplegic CP. The investigators will address four areas of feasibility to 1) Understand the demand for the BB intervention (i.e., expressed interest in the program), 2) Establish probable efficacy for clinical outcomes related to UL function, activity, and participation, 3) Evaluate implementation of the 8-week BB intervention and 4) Explore acceptability (e.g., participants' experiences).
Fifteen children with a diagnosis of hemiplegic CP (7-17 yrs) and one of their primary caregivers will participate. This study consists of three phases, each one contributing to the development of the next one. In Phase 1 (demand), recruitment rates and percentage of children with appropriate in-home technology to play will be collected during screening. A pre-intervention interview will explore participants' expectations for the intervention. In Phase 2, study assessments will be performed via videoconference (probable efficacy). Measures will target UL activity and related participation. Children will play BB at home for 8 weeks. Computer-system logs and data from reported technical barriers will be collected (implementation). In Phase 3 parents and children will participate in a post-intervention interview to explore their experiences and perceived value of the BB program (acceptability).
Worldwide, children face accessibility barriers to motor therapy services. This study will provide learnings on how therapy gaming interventions can/should be implemented to bridge accessibility gaps, engage children and improve access to care.
详细描述
RESEARCH QUESTION AND OBJECTIVES This feasibility study will use a multi-stage mixed methods design20. It aims to address the possibility of successfully implementing the BB program intervention in a small scale, semi-controlled, real-world environment among Costa Rican families with children with hemiplegic CP. It will address our overall research question: To what extent is a video game designed for upper limb therapy (BB) feasible for use in a home rehabilitation program for children with hemiplegic CP in Costa Rica who experience barriers accessing therapy services? In this study, the investigators are particularly interested in four areas of feasibility: demand, implementation, limited-efficacy testing and acceptability as defined by Bowen et al17. Demand looks at the extent to which an intervention is likely to be used in a given setting or population. Implementation evaluates the extent to which the intervention can be implemented as proposed. Limited-efficacy aims to inform the potential of the intervention in a limited way (e.g., convenience sample). Acceptability focuses on how participants react to the intervention.
To address our research question, our specific objectives are:
- To understand demand for the BB intervention, including expressed interest in the program, capacity to integrate BB into the family home and routine, and the expectations of children with hemiplegic CP and their parents for the BB intervention.
Indicators:
- Recruitment rate of 3 child-parent dyad a month for 5 months (n=15), with a ≥10% response rate (i.e., expressed interest, fit the eligibility criteria)
- At least 80% of families who wish to participate will have an appropriate screen and space to play BB.
- The family-directed play time goal, which is sensitive to family schedules and routines, provides a "therapy dose" that could reasonably be expected to be clinically meaningful [i.e., at least 45 minutes a week13].
- The family can define at least one therapy goal that aligns with the scope of the BB intervention.
- Identify the expectations that children and their parents have of the BB program (e.g., improving in a meaningful activity involving the upper limb, having a fun alternative to exercise their hands/arms).
- To establish limited efficacy by measuring pre-post intervention changes in clinical outcomes related to upper limb function, activities and participation in children with hemiplegic CP using BB for 8 weeks at home.
Indicators:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Outcome Assessor for primary outcome measure is blinded to the time of assessment (eg., baseline, pre-intervention, intervention or post-intervention).
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hemiplegic CP.
- •7 to 17 years of age: This age range was selected given the popularity of video games for children at this stage. This age group in CP has been studied successfully in previous research focused on active video game play, showing potential for change across their motor outcomes8-
- •Motor impairment of the upper limb: difficulty to manipulate objects and/or perform activities of daily living with one hand/arm in alignment with the Manual Classification System levels I-III18, as reported by the parent and assessed via telephone by the clinician-researcher (DC - Appendix B, telephone screening). These children would require minimal assistance in playing the video game in the home environment.
- •Having a primary family caregiver willing to participate.
- •Resident of Costa Rica.
- •Child and parent are able to understand and communicate verbally in Spanish or English.
- •Child and/or parent are able to read and write.
- •Child and/or parent has knowledge on how to use email and receive a video call or have a support person willing to assist them during the clinical assessment processes.
- •Child and/or parent has access to a cellphone or computer at home.
- •Ability to cooperate, understand, and follow simple instructions for game play as reported by parent.
- •Having a TV screen (or similar) at home.
- •Having an accessibility barrier that currently limits their access to upper limb rehabilitation services. These barriers include but are not limited to: the family is unable to pay for therapy, services are not available in their living area, or there is a lack of adapted transportation for the child to travel to a therapy center, as reported by the caregiver.
排除标准
- •Receiving hand and arm therapy at the time of intervention.
- •History of uncontrolled epilepsy. If the child has a history of epilepsy, they will require a note from a doctor indicating it would be safe to play video games as required in this study. A note will not be required if the child currently engages in at least 30 minutes of screen time a day on 2 or more days in a week as documented by a primary caregiver.
- •Visual or hearing impairments that limit the ability to play the video game.
- •Has received constraint induced movement therapy in the past 6 months, or botulinum toxin injections, or active therapy of the upper extremity within three months of the study enrollment.
- •History of upper limb injury or disability that would make light exercise unsafe as reported by the caregiver.
结局指标
主要结局
Change in Canadian Occupational Performance Measure (COPM)
时间窗: week 5 (pre assessment session), week 15 (post assessment session)
The COPM evaluates the performance, and the satisfaction with performance of self-identified therapy goals. Participants will first identify hand/arm goals of daily life activities that they wish to improve (e.g., cutting with fork and knife). Parent and child will rate together the child's level of performance and satisfaction with performance over a 10-point numerical scale (1 is poor/low and 10 is high/good) for each of their identified goals. This measure has shown good reliability, construct validity and responsiveness for use with children with CP. A change of 2 points is considered a minimal clinically important response
Change in Quality of Upper Extremity Skills Test (QUEST)
时间窗: weeks 4 & 5 (pre assessment sessions), week 15 (post assessment session)
The QUEST is a 34-item criterion-referenced observation test with four domains: dissociated movement, grasp, weight-bearing, and protective extension. Domain scores are a summed item score which is converted into a standardized percentage. The total score is an average of the domain scores with higher scores indicating increased levels of achievement. The reliability and the concurrent validity for the study population is well established. For the purposes of this research study, only the dissociated movement and grasp domains will be used as the weight-bearing and protective extension dimensions may be more difficult to capture over Zoom. The minimally clinically important difference (MCID) for the QUEST is reported as a positive change of 4.89 score units on any dimension. The QUEST requires a chair and table to sit at, four 1" cubes, a cup, a pencil or crayon, blank paper and cheerios.
次要结局
- Change on the Performance Quality Rating Scale (PQRS)(weekly throughout study completion, on average 15 weeks)
- Change in the Box and Blocks Test (BBT)(weeks 4 & 5 (pre assessment sessions), week 15 (post assessment session))
- Count of number of intentional therapeutic movements achieved during active and passive playtime.(Weeks 1 to 8 during the intervention)
- Active Range of Motion (aROM)(weeks 4 & 5 (pre assessment sessions), week 15 (post assessment session))
- Change on the Shriners Hospital for Children Upper Extremity Evaluation (SHUEE)(weeks 4 & 5 (pre assessment sessions), week 15 (post assessment session))
- Change on the Children's Hand-Use Experience Questionnaire(week 4 (pre assessment session), and week 15 (post assessment session))
研究者
Elaine Biddiss
Senior Scientist
Holland Bloorview Kids Rehabilitation Hospital