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临床试验/NCT04009031
NCT04009031终止不适用

Evaluation of a Novel Video Game for Home-based Rehabilitation for Children With Hemiplegic Cerebral Palsy.

Holland Bloorview Kids Rehabilitation Hospital2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2018年10月9日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
2
主要终点
Change in the Canadian Occupational Performance Measure (COPM)

研究概览

简要总结

This study evaluates the feasibility of a low-cost, movement tracking video game (Bootle Blast) to 1) sustain engagement in children with cerebral palsy (CP) during a 12-week intervention; and 2) generate changes in upper limb functional motor outcomes following the intervention.

详细描述

Children with Cerebral Palsy (CP) can benefit from home-based practice of therapy exercises. However, sustaining engagement in home-based therapy is challenging. Bootle Blast is a low-cost video game that uses the Microsoft Kinect sensor to track upper limb movements and interactions with real-life objects (e.g. musical instruments, building blocks). To play Bootle Blast, the child needs to use the hemiplegic arm/hand to play unilateral game activities, and highly involve it in bilateral activities.

This study will answer our research questions: 1) to what extent can children achieve a weekly play-time goal (PTG) over a 12-week intervention (adherence) when the PTG is family identified? 2) to what extent can the use of Bootle Blast lead to improvements in UL motor function? and 3) what are the participant's experiences of using BB for home rehabilitation?

As measures of feasibility we hypothesize that 1a) 75% of children will achieve their weekly play time goal and complete the 12-week intervention and 2) 75% children who achieve their weekly play time goal will improve in one or more UL motor outcome measures.

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

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • diagnosis of hemiplegic Cerebral Palsy, Gross Motor Function Classification System and Manual Abilities Classification System Levels I to III, able to co-operate, understand and follow simple instructions for gameplay, live within 30 km of the Holland Bloorview Kids Rehabilitation Hospital, having a caregiver willing to participate.

排除标准

  • currently receiving active occupational or physical therapy that may impact motor function of the upper limb, Botulinum Toxin treatment within 3 months or Constraint-Induced Movement Therapy within 6 months of study enrollment, visual, cognitive or auditory limitations at a level that would interfere with gameplay, uncontrolled epilepsy or history of epilepsy related to video game play.

结局指标

主要结局

Change in the Canadian Occupational Performance Measure (COPM)

时间窗: baseline (week 0), post-intervention (week 13), and follow-up (week 17)

Addresses research question 2. COPM evaluates self- or parent-reported satisfaction and performance on self-identified therapy goals. Participants will identify, with the help of the occupational therapists during the baseline assessment, 1-3 upper limb goals related to daily life activities (e.g., tie shoelaces). Parent and child will rate together performance and satisfaction with performance on a 10-point scale (1 is poor/low and 10 is good/high) for each goal.

Video game logs

时间窗: Through out the 12-week intervention.

Addresses research question 1. Every time the computer is turned on to play the video game, a video game log is automatically generated. The game logs active play time (i.e. time in minutes spent actively engaging in therapeutic movements) and passive play time (e.g. time spent navigating menus). Additional data that is recorded in game logs includes: game scores, games played and time in each game, rewards collected, and location of the joints (e.g. elbow, shoulder) as tracked by the Microsoft Kinect sensor. Data recorded in the video game will be used to identify the percentage of children that met their weekly play time goal, and on how many weeks this goal was achieved.

Semi-structured interviews

时间窗: Post-intervention (week 13).

Addresses research question 3. Parent and child will participate in a post intervention semi-structured interview to explore features related to engagement and intervention acceptability.

Change in the Assisting Hand Assessment (AHA)

时间窗: baseline (week 0), post-intervention (week 13), and follow-up (week 17)

Addresses research question 2. The AHA evaluates the use of the affected hand in assisting during the performance of 22 bimanual activities. Each task is rated on a 4-point rating scale (4=effective, 0= does not do). Tasks include object manipulation from the AHA toy kit, which are scored under the categories of general use, arm use, grasp and release, fine motor adjustments and coordination and pace. Rasch analysis converts raw scores into a logit-based scale ranging from 0-100, with higher scores representing a higher ability.

次要结局

  • Grip strength(baseline (week 0), post-intervention (week 13) and follow-up (week 17))
  • Change in Children's Hand-use Experience Questionnaire (CHEQ)(baseline (week 0), post-intervention (week 13) and follow-up (week 17))
  • Change in Box and Block test(baseline (week 0), post-intervention (week 13) and follow-up (week 17))
  • Change in range of motion(baseline (week 0), post-intervention (week 13) and follow-up (week 17))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elaine Biddiss

Doctor

Holland Bloorview Kids Rehabilitation Hospital

研究点 (2)

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