Video Gaming for Home Rehabilitation for Children With Hemiplegic Cerebral Palsy in Costa Rica

NCT05403567 | Unknown DMC

• 1 other identifier: 0318
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Hemiplegic Cerebral Palsy

Keywords

home rehabilitation; upper limb; videogame; mixed methods

Outcome Measures

Primary Outcomes (2)

• Change in Quality of Upper Extremity Skills Test (QUEST)

  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.

  weeks 4 & 5 (pre assessment sessions), week 15 (post assessment session)

• Change in Canadian Occupational Performance Measure (COPM)

  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

  week 5 (pre assessment session), week 15 (post assessment session)

Secondary Outcomes (6)

• Active Range of Motion (aROM)

  weeks 4 & 5 (pre assessment sessions), week 15 (post assessment session)

• Change on the Performance Quality Rating Scale (PQRS)

  weekly throughout study completion, on average 15 weeks

• Change on the Shriners Hospital for Children Upper Extremity Evaluation (SHUEE)

  weeks 4 & 5 (pre assessment sessions), week 15 (post assessment session)

• Change in the Box and Blocks Test (BBT)

  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)

Study Arms (1)

Bootle Blast Intervention

EXPERIMENTAL

Children will play the Bootle Blast game at home for 8 continuous weeks.

Other: Bootle Blast Home Intervention

Interventions

Bootle Blast Home Intervention OTHER

Children will play BB at home for 8 continuous weeks. Participants will be asked to stop playing at the end of week 8 and the game will be programmatically locked to prevent further play until the post-intervention interviews and assessments are complete.

Also known as: Bootle Blast Program

Bootle Blast Intervention

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of hemiplegic CP.
• 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 outcomes8-10.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead
• Universidad de Costa Rica: collaborator

Study Sites (2)

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G 1R8, Canada

Location

Universidad de Costa Rica

San Pedro, Provincia de San José, 11501, Costa Rica

Location

Related Publications (8)

• Bilde PE, Kliim-Due M, Rasmussen B, Petersen LZ, Petersen TH, Nielsen JB. Individualized, home-based interactive training of cerebral palsy children delivered through the Internet. BMC Neurol. 2011 Mar 9;11:32. doi: 10.1186/1471-2377-11-32.

  PMID: 21392370 BACKGROUND

• Biddiss E, Chan-Viquez D, Cheung ST, King G. Engaging children with cerebral palsy in interactive computer play-based motor therapies: theoretical perspectives. Disabil Rehabil. 2021 Jan;43(1):133-147. doi: 10.1080/09638288.2019.1613681. Epub 2019 May 19.

  PMID: 31104517 BACKGROUND

• Fetters MD, Curry LA, Creswell JW. Achieving integration in mixed methods designs-principles and practices. Health Serv Res. 2013 Dec;48(6 Pt 2):2134-56. doi: 10.1111/1475-6773.12117. Epub 2013 Oct 23.

  PMID: 24279835 BACKGROUND

• Romeiser-Logan L, Slaughter R, Hickman R. Single-subject research designs in pediatric rehabilitation: a valuable step towards knowledge translation. Dev Med Child Neurol. 2017 Jun;59(6):574-580. doi: 10.1111/dmcn.13405. Epub 2017 Feb 22.

  PMID: 28224606 BACKGROUND

• Cusick A, Lannin NA, Lowe K. Adapting the Canadian Occupational Performance Measure for use in a paediatric clinical trial. Disabil Rehabil. 2007 May 30;29(10):761-6. doi: 10.1080/09638280600929201.

  PMID: 17457734 BACKGROUND

• Martini R, Rios J, Polatajko H, Wolf T, McEwen S. The performance quality rating scale (PQRS): reliability, convergent validity, and internal responsiveness for two scoring systems. Disabil Rehabil. 2015;37(3):231-8. doi: 10.3109/09638288.2014.913702. Epub 2014 Apr 28.

  PMID: 24766150 BACKGROUND

• Skold A, Hermansson LN, Krumlinde-Sundholm L, Eliasson AC. Development and evidence of validity for the Children's Hand-use Experience Questionnaire (CHEQ). Dev Med Child Neurol. 2011 May;53(5):436-42. doi: 10.1111/j.1469-8749.2010.03896.x. Epub 2011 Mar 17.

  PMID: 21413973 BACKGROUND

• Chan-Viquez D, Fernandez-Huertas H, Montserrat-Gonzalez C, Khan A, Fehlings D, Munce S, Wright FV, Biddiss E. Feasibility of a home-based home videogaming intervention with a family-centered approach for children with cerebral palsy: a randomized multiple baseline single-case experimental design. J Neuroeng Rehabil. 2024 Sep 4;21(1):151. doi: 10.1186/s12984-024-01446-2.

  PMID: 39227911 DERIVED

Study Officials

• Elaine Biddiss, PhD

  Holland Bloorview Kids Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Outcome Assessor for primary outcome measure is blinded to the time of assessment (eg., baseline, pre-intervention, intervention or post-intervention).
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: June 3, 2022
• Study Start: January 24, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1); CA (1)