Clinical trial NCT04009031: Video Game for Home-based Rehabilitation for Children With Hemiplegia
Official title: Evaluation of a Novel Video Game for Home-based Rehabilitation for Children With Hemiplegic Cerebral Palsy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Child
Hemiplegic Cerebral Palsy
Keywords: video games
upper extremity
rehabilitation
cerebral palsy
Lead sponsor: Holland Bloorview Kids Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Natural Sciences and Engineering Research Council, Canada
name: Canadian Institutes of Health Research (CIHR)
name: Ontario Brain Institute
First posted: 2019-07-05
Enrollment: 4
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will undergo a clinical assessment at 3-time points: baseline, post-intervention, and one-month follow-up. Clinical assessments will take approximately 2 hours and will be carried out at the Holland Bloorview Kids Rehabilitation Hospital by an occupational therapist. A research assistant will visit the child's home 3 times throughout the duration of the intervention (weeks 1, 6 and 12). During the last home visit, semi-structured interviews will be conducted individually with the parent and child.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Video game logs
timeFrame: Through out the 12-week intervention.
measure: Change in the Canadian Occupational Performance Measure (COPM)
timeFrame: baseline (week 0), post-intervention (week 13), and follow-up (week 17)
measure: Change in the Assisting Hand Assessment (AHA)
timeFrame: baseline (week 0), post-intervention (week 13), and follow-up (week 17)
measure: Semi-structured interviews
timeFrame: Post-intervention (week 13).
Secondary outcomes:
measure: Change in range of motion
timeFrame: baseline (week 0), post-intervention (week 13) and follow-up (week 17)
measure: Grip strength
timeFrame: baseline (week 0), post-intervention (week 13) and follow-up (week 17)
measure: Change in Box and Block test
timeFrame: baseline (week 0), post-intervention (week 13) and follow-up (week 17)
measure: Change in Children's Hand-use Experience Questionnaire (CHEQ)
timeFrame: baseline (week 0), post-intervention (week 13) and follow-up (week 17)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Holland Bloorview Kids Rehabilitation Hospital
state: Ontario
Study officials:
affiliation: Bloorview Research Institute
name: Elaine Biddiss, PhD
role: PRINCIPAL_INVESTIGATOR
References: