Cerebral PalsyNCT04298411
Project Falcon: Exploring a Virtual Reality-based Video Game for Young People With Cerebral Palsy
A study testing Falcon in people with Cerebral Palsy, run by Holland Bloorview Kids Rehabilitation Hospital at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Falcon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jan 2016to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Centre interdisciplinaire de recherche en réadaptation et en intégration sociale
Québec, G1M 2S8
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M4G 1R8
About this study
Official title: Project Falcon: Exploring a Virtual Reality-based Video Game With Haptic Feedback for Sensory-motor Rehabilitation of Young People With Cerebral Palsy
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.
Read the 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:
- 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.
- 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.
- Conditions
- Cerebral Palsy
- Being tested
- Falcon
- Keywords
- haptic feedback, Novint Falcon, upper limb motor function, rehabilitation, motor learning, neuroplasticity, video games
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FalconDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Falcon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).
Secondary outcomes (5)
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: Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).
active/passive range of motion
A goniometer is used to measure degrees of active/passive range of motion of the wrist.
Measured: Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).
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: Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).
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: Measured at 1 week, 6 weeks, and 12 weeks.
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: Measured at 1 week, 6 weeks, and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start1 Jan 2016
- Primary completion30 Oct 2018
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elaine Biddiss, PhD, Principal investigator, Holland Bloorview Kid's Rehabilitation HospitalJean-Sébastien Roy, PT, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298411
- Sponsor's protocol ID
- 14-530
- Status last verified
- Dec 2019
- First submitted
- 29 Jan 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD sharing plans.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Falcon: Exploring a Virtual Reality-based Video Game With Haptic Feedback for Sensory-motor Rehabilitation of Young People With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04298411
- Acronym / sponsor ID
- 14-530
- Conditions
- Cerebral Palsy
- Keywords
- haptic feedback, Novint Falcon, upper limb motor function, rehabilitation, motor learning, neuroplasticity, video games
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Device: FalconParticipants 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. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FalconThe 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. | Device | Experimental Arm |
Primary outcome
Change in Canadian Occupational Performance Measure (COPM)
Time frame: Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).
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.
5 secondary outcomes
Change in Grip Strength
Time frame: Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).
active/passive range of motion
Time frame: Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).
Change in Children's Hand-use Experience Questionnaire (CHEQ)
Time frame: Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).
Change in Shortened Physical Activity Enjoyment Scale (S-PACES)
Time frame: Measured at 1 week, 6 weeks, and 12 weeks.
Change in the answers reported in custom feedback questionnaires
Time frame: Measured at 1 week, 6 weeks, and 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Individual participant dataSharing planned: No. No IPD sharing plans.
Related trials for Cerebral Palsy
Recruiting
Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation
Cerebral Palsy
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
RecruitingPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform
Progressive Supranuclear Palsy(PSP)
RecruitingObservational study
Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy
Cerebral Palsy Infantile
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine Biddiss, PhD principal investigator
Holland Bloorview Kid's Rehabilitation Hospital
Jean-Sébastien Roy, PT, PhD principal investigator
Laval University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Falcon in people with Cerebral Palsy, run by Holland Bloorview Kids Rehabilitation Hospital at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Canadian Occupational Performance Measure (COPM) (time frame: Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.