Clinical trial NCT04298411: Project Falcon: Exploring a Virtual Reality-based Video Game for Young People With Cerebral Palsy
Official title: Project Falcon: Exploring a Virtual Reality-based Video Game With Haptic Feedback for Sensory-motor Rehabilitation of Young People With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: haptic feedback
Novint Falcon
upper limb motor function
rehabilitation
motor learning
neuroplasticity
video games
Lead sponsor: Holland Bloorview Kids Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 14
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Motivation: Children with cerebral palsy (CP) experience various challenges in upper limb motor function (e.g. muscle weakness, impaired manual abilities, spasticity, ataxia, athetosis and/or dystonia) that can impede their activities and participation in daily life. Rehabilitation strategies to support children with CP in achieving improved upper limb control target these areas through strengthening, endurance building, and motor learning activities. Neuroplasticity and motor learning are promoted by repetitive practice in a motivating and rewarding environment, immediate feedback on performance, and use of tasks with appropriate complexity that is increased as progress is made. Many elements of video games (e.g. progressive difficulty levels, engaging game play) may support motor learning and early evidence suggests that interactive computer play is likely effective for improving lower limb function with some promising indications for upper limb rehabilitation. The majority of evidence comes from studies that have used commercial gaming systems where children interact with virtual objects on the screen via their movements. These systems, however, do not provide haptic feedback, which may aid in motor learning and the transference of skills practiced in virtual environments to real-life.

The Novint Falcon is a low-cost, three degree-of-freedom video game controller that can provide force and tactile feedback during game play. The three motors that enable the provision of haptic feedback can also be used to assist movements. A software development kit is available and enables custom design of games and applications. One previous study investigated this device in adults for stroke rehabilitation. While promising, one drawback identified was that the available mini-games did not practice therapeutically relevant movements.

Objective: Considering the upper limb motor challenges experienced by children with CP and the potential of the Novint Falcon to assist in their rehabilitation, research is needed to develop challenging video games adapted for this controller. The objectives of this proposal are 1) to adapt a low-cost haptic controller and compile a set of video games that provide tactile and force feedback for the rehabilitation of young people with CP, and 2) to explore the feasibility of the system and the effects on upper limb and hand function.

Methods: In pursuit of these two objectives:

1. Existing mini-games will be reviewed in partnership with therapists to identify promising games. Thereafter, new mini-games will be designed as needed to meet with therapeutic goals identified by the therapists. The design of the controller's grip will then be reviewed via a participatory design approach that engages both therapists and children with CP. New grips will be created as needed.
2. The resulting system will be evaluated in a clinic setting by children with hemiplegic CP (ages 7 to 16 years; n=14; 7/site) at Holland Bloorview Kids Rehabilitation Hospital and Institut de réadaptation en déficience physique de Québec. Each child with CP will take part in one initial assessment session, 12 one-hour rehabilitation sessions over 12 weeks during which they will play games developed for the Novint Falcon, and one final assessment session. Independent evaluators will assess the children with CP before (two baseline measurements will be established) and after the 12-week intervention. The outcomes of interest include: Canadian Occupational Therapy Performance Measure, Quality of Upper Extremity Skills Test, sensory profile, grip strength, and upper extremity range of motion. Further, child participants will complete the Physical Activity Enjoyment Scale, while therapists will complete the System Usability scale.

Expected Outcomes. The results of this study if promising, will lay the foundation for a CIHR grant to explore the role of haptic feedback in interactive computer play therapies. Through this research, the investigators hope to offer an appealing tool to aid in the rehabilitation of children with CP that is both therapeutically valuable and enjoyable.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Canadian Occupational Performance Measure (COPM)
timeFrame: Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).
Secondary outcomes:
measure: Change in Grip Strength
timeFrame: Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).
measure: active/passive range of motion
timeFrame: Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).
measure: Change in Children's Hand-use Experience Questionnaire (CHEQ)
timeFrame: Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).
measure: Change in Shortened Physical Activity Enjoyment Scale (S-PACES)
timeFrame: Measured at 1 week, 6 weeks, and 12 weeks.
measure: Change in the answers reported in custom feedback questionnaires
timeFrame: Measured at 1 week, 6 weeks, and 12 weeks.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Holland Bloorview Kids Rehabilitation Hospital
state: Ontario
city: Québec
country: Canada
facility: Centre interdisciplinaire de recherche en réadaptation et en intégration sociale
Study officials:
affiliation: Holland Bloorview Kid's Rehabilitation Hospital
name: Elaine Biddiss, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laval University
name: Jean-Sébastien Roy, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: