Project Falcon: Exploring a Virtual Reality-based Video Game for Young People With Cerebral Palsy

NCT04298411 | Completed

• 1 other identifier: 14-530
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

This study seeks to 1) adapt a low-cost controller, the Novint Falcon, and a set of video games that would provide rehabilitative feedback for young people with cerebral palsy, and 2) explore feasibility of the Falcon system and it's effect on upper limb and hand function.

Conditions

Cerebral Palsy

Keywords

haptic feedback; Novint Falcon; upper limb motor function; rehabilitation; motor learning; neuroplasticity; video games

Outcome Measures

Primary Outcomes (1)

• Change in Canadian Occupational Performance Measure (COPM)

  The Canadian Occupational Performance Measure evaluates changes in perceived function and satisfaction of performance in self-identified goal areas. The child and parent work together with the therapist to identify 1-3 goals of interest. For each goal area, the child/parent ranks its importance, performance and satisfaction on a scale of 1-10. A higher rating indicates a more positive outcome.

  Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).

Secondary Outcomes (5)

• Change in Grip Strength

  Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).

• active/passive range of motion

  Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).

• Change in Children's Hand-use Experience Questionnaire (CHEQ)

  Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).

• Change in Shortened Physical Activity Enjoyment Scale (S-PACES)

  Measured at 1 week, 6 weeks, and 12 weeks.

• Change in the answers reported in custom feedback questionnaires

  Measured at 1 week, 6 weeks, and 12 weeks.

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Participants will take part in 12 one-hour rehabilitation sessions over 12 weeks in the clinic at Holland Bloorview Kids Rehabilitation Hospital and Institut de réadaptation en déficience physique de Québec, during which they will play games developed for the Novint Falcon.

Device: Falcon

Interventions

Falcon DEVICE

The Falcon contains a selection of 25+ games that require wrist extension and challenges children to grasp the controller with their affected hand. As children progress, they may advance to more difficult games that challenge the child to work against a resistance and/or apply greater grip forces. Therapists will be trained on the system, games, and given a guide summarizing the available games and the motor function areas targeted in the game. Using this guide, therapists can choose the games that are most suited to the child's abilities and goals. As multiple games will target many of the same motor function areas, children will have the option of choosing the games they like best to maximize motivational value. While this introduces some variability in the intervention, this flexibility is required to ensure that the therapy is targeting the specific interests, needs and goals of each individual child and is reflective of how ICP is used in a clinic setting.

Experimental Arm

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of hemiplegic cerebral palsy
• Level I to III on the Manual Abilities Classification System (MACS)
• Ability to understand and communicate in English (Holland Bloorview site) or French (IRDPQ site) at a grade 2 level or higher

You may not qualify if:

• Received Botulinum Toxin in the most recent 3 months
• History of epilepsy
• Past experience of an injury or disability that would render therapy unsafe
• Visual, cognitive or auditory disabilities that interfere with the ICP

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead

Study Sites (2)

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G 1R8, Canada

Location

Centre interdisciplinaire de recherche en réadaptation et en intégration sociale

Québec, G1M 2S8, Canada

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Elaine Biddiss, PhD

  Holland Bloorview Kid's Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

• Jean-Sébastien Roy, PT, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: March 6, 2020
• Study Start: January 1, 2016
• Primary Completion: October 30, 2018
• Study Completion: June 1, 2019
• Last Updated: March 6, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)