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

Cerebral Palsy Clinical Trial

Official title:

Project Falcon: Exploring a Virtual Reality-based Video Game With Haptic Feedback for Sensory-motor Rehabilitation of Young People With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04298411
• Other study ID #: 14-530
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: June 1, 2019

Study information

• Verified date: December 2019
• Source: Holland Bloorview Kids Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 1, 2019
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• Falcon
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.

Locations

Country	Name	City	State
Canada	Centre interdisciplinaire de recherche en réadaptation et en intégration sociale	Québec
Canada	Holland Bloorview Kids Rehabilitation Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Holland Bloorview Kids Rehabilitation Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Grip Strength	A sphygmomanometer is used to measure grip strength of the hand by determining the amount of pressure (mmHg) that the hand can apply.	Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).
Secondary	active/passive range of motion	A goniometer is used to measure degrees of active/passive range of motion of the wrist.	Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).
Secondary	Change in Children's Hand-use Experience Questionnaire (CHEQ)	Children's Hand-use Experience Questionnaire (CHEQ) is a 29 item child- or parent- completed questionnaire that examines how the weaker/affected limb is used in everyday activities. It presents a list of common daily activities that typically require use of two hands.The minimum score value is 0 and the maximum score value is 100. A higher score means a better outcome.	Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).
Secondary	Change in Shortened Physical Activity Enjoyment Scale (S-PACES)	Consists of 10 pairs of statements scored on a 5-point Likert scale that probe factors in enjoyment of physical activity. The minimum score value is 1 and the maximum score value is 5. A higher score means a better outcome.	Measured at 1 week, 6 weeks, and 12 weeks.
Secondary	Change in the answers reported in custom feedback questionnaires	Custom feedback questionnaires will be used to evaluate the perceived quality of feedback, motivation, and difficulty of tasks during ICP therapies. It is based on validated questionnaires for measuring usability (SUS) and enjoyment (Flow short) and a custom questionnaire used in a previous study investigating ICP therapy games with this population. The custom feedback questionnaire consists of open-ended questions.; Open-ended questions include: What did you like about the games? What didn't you like about the games? What would make the games more fun?	Measured at 1 week, 6 weeks, and 12 weeks.