Cerebral PalsyNCT03386968
Virtual Reality and Active Video Games to Improve Balance in Children With Brain Injury
A study testing Active video gaming in people with Cerebral Palsy and Acquired Brain Injury, run by Blythedale Children's Hospital at 1 site in United States.
Trial summary
The purpose of this pilot feasibility study is to assess the feasibility of using the Playstation Xbox 360 and Rutgers V-step via a Kinect Sensor with active video game software as a part of a physical therapy intervention to improve obstacle negotiation, gait speed, and stair negotiation in ambulatory children with… Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Cerebral Palsy, Acquired Brain Injury
- What is being tested?
- Active video gaming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2017to 6 Jan 2022
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 7-17
- Diagnosis of Cerebral Palsy or Diagnosis of Acquired Brain Injury
- Ambulatory with or without an assistive device x 150 feet
- Cognition and attention ability sufficient to be successful in video game play and to follow instructions of the investigator.
- Able to complete testing process.
- Current patient at Blythedale Children's Hospital program (Expected Length of Stay/availability for study of approximately 8 weeks)
Who cannot join
- Any history of photosensitive epilepsy or seizures triggered by exposure to flashing lights, television or video games
- Attention or behavior problems that prevent the successful completion of game play
- Any acute musculoskeletal injury that limits weight bearing on one lower extremity (due to orthopedist concerns for fracture or injury)
- Any medical condition that prevents the child from tolerating exercise due to cardiovascular conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Blythedale Children's Hospital
Valhalla, New York, 10595
About this study
Official title: Use of Low-Cost Virtual Reality and Active Video Games to Improve Balance and Perceptual Skills in Children With Cerebral Palsy and Brain Injury
The purpose of this pilot feasibility study is to assess the feasibility of using the Playstation Xbox 360 and Rutgers V-step via a Kinect Sensor with active video game software as a part of a physical therapy intervention to improve obstacle negotiation, gait speed, and stair negotiation in ambulatory children with Cerebral Palsy (CP) hemiparesis or spastic diplegia, or non-progressive brain injury (BI). Children will be assessed using perceptual, balance, functional and gait assessments.
- Conditions
- Cerebral Palsy, Acquired Brain Injury
- Being tested
- Active video gaming, Usual care physical therapy
- Keywords
- virtual reality, hemiplegia, diplegia, video gaming, active video games, Playstation X-Box 360, Rutgers V-Step, Microsoft Kinect
- Medical subject headings
- Cerebral Palsy, Brain Injuries, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active video gamingBehavioural
Children will visit Blythedale for 8 sessions, one 45-session visit per week, in place of one of the child's typical physical therapy sessions. During each session, children will play a video game on the X-Box Kinect system, using the games "Kinect Adventures" and "Kinect Sports". The child will first play a "Kinect Adventures" game, which requires ambulating, ducking, and dodging one's way through an obstacle course.
Usual care physical therapyBehavioural
Children will attend their usual care physical therapy appointments at Blythedale.
| Study group | Role | What they receive |
|---|---|---|
| Video gaming | Experimental | A child's usual physical therapy session will be replaced with a session utilizing Active video games and the Rutger's V-step. Receives: Behavioral: Active video gaming |
| Usual care | Active comparator | Children will receive their usual care in the physical therapy program at Blythedale. Receives: Behavioral: Usual care physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test
The PEDI-CAT measures abilities in three functional domains: Daily Activities, Mobility and Social/Cognitive.
Measured: From before intervention to immediately after intervention
Secondary outcomes (7)
Change in 10 Meter walk test
Measures time taken for a participant to walk 10 meters
Measured: From before intervention to immediately after intervention
Change in Gross Motor Function Measure (GMFM) subtest D and E
The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy.
Measured: From before intervention to immediately after intervention
Change in Four Square Step Test
Measures how well a patient can change directions while stepping.
Measured: From before intervention to immediately after intervention
Change in Functional Gait Assessment (FGA)
10-item test that assesses dynamic balance and postural stability during gait.
Measured: From before intervention to immediately after intervention
Change in Motor Free Visual Perceptual Test (MVPT)-4
The MVPT-4 assesses five categories of visual perception: Visual Discrimination: Ability to discriminate dominant features of different objects, including the ability to discriminate position, shapes, and forms.
Measured: From before intervention to immediately after intervention
Change in Visually guided weight shift ability as measured by the Smart Balance Master®
Force platform system that tests balance
Measured: From before intervention to immediately after intervention
Change in Children's Assessment of Participation and Enjoyment
Self-report measures of children's participation in recreation and leisure activities outside of mandated school activities.
Measured: From before intervention to immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start7 Dec 2017
- Primary completion6 Jan 2022
- Study completion6 Jan 2022
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized Block Design will be utilized in order to attempt to "match" subjects according to functional level and diagnosis (cerebral palsy or acquired brain injury). Upon signing consent the subjects will be grouped based on their diagnosis. At that time gait speed for the 10 M Walk Test will be utilized to categorize all participants into a "fast" and "slow" group. (subjects performing the 10 M Walk Test at a speed less than .4 m/s will be placed in the "slow" group, and subjects testing at a speed greater than or equal to .4 m/s will be placed in the "fast" group After this determination is made, subjects will be randomized to "control" (usual care), and "intervention" one therapy session replaced with a session utilizing Active video games and the Rutger's V-step. A minimum of 2 subjects per grouping will be sought in order to analyze for differences.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blythedale Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386968
- Sponsor's protocol ID
- 17-1206TS
- Status last verified
- Jan 2022
- First submitted
- 7 Dec 2017
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Low-Cost Virtual Reality and Active Video Games to Improve Balance and Perceptual Skills in Children With Cerebral Palsy and Brain Injury
- ClinicalTrials.gov ID
- NCT03386968
- Acronym / sponsor ID
- 17-1206TS
- Conditions
- Cerebral Palsy, Acquired Brain Injury
- Keywords
- virtual reality, hemiplegia, diplegia, video gaming, active video games, Playstation X-Box 360, Rutgers V-Step, Microsoft Kinect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Blythedale Children's HospitalUniversity, hospital or other
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 6 Jan 2022 (actual)
- First posted
- 29 Dec 2017 (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.
The purpose of this pilot feasibility study is to assess the feasibility of using the Playstation Xbox 360 and Rutgers V-step via a Kinect Sensor with active video game software as a part of a physical therapy intervention to improve obstacle negotiation, gait speed, and stair negotiation in ambulatory children with Cerebral Palsy (CP) hemiparesis or spastic diplegia, or non-progressive brain injury (BI). Children will be assessed using perceptual, balance, functional and gait assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Randomized Block Design will be utilized in order to attempt to "match" subjects according to functional level and diagnosis (cerebral palsy or acquired brain injury). Upon signing consent the subjects will be grouped based on their diagnosis. At that time gait speed for the 10 M Walk Test will be utilized to categorize all participants into a "fast" and "slow" group. (subjects performing the 10 M Walk Test at a speed less than .4 m/s will be placed in the "slow" group, and subjects testing at a speed greater than or equal to .4 m/s will be placed in the "fast" group After this determination is made, subjects will be randomized to "control" (usual care), and "intervention" one therapy session replaced with a session utilizing Active video games and the Rutger's V-step. A minimum of 2 subjects per grouping will be sought in order to analyze for differences.
| Arm | Type | Receives |
|---|---|---|
| Video gaming | Experimental | Behavioral: Active video gamingA child's usual physical therapy session will be replaced with a session utilizing Active video games and the Rutger's V-step. |
| Usual care | Active comparator | Behavioral: Usual care physical therapyChildren will receive their usual care in the physical therapy program at Blythedale. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 7-17
- Diagnosis of Cerebral Palsy or Diagnosis of Acquired Brain Injury
- Ambulatory with or without an assistive device x 150 feet
- Cognition and attention ability sufficient to be successful in video game play and to follow instructions of the investigator.
- Able to complete testing process.
Key exclusion criteria (4 listed)
- Any history of photosensitive epilepsy or seizures triggered by exposure to flashing lights, television or video games
- Attention or behavior problems that prevent the successful completion of game play
- Any acute musculoskeletal injury that limits weight bearing on one lower extremity (due to orthopedist concerns for fracture or injury)
- Any medical condition that prevents the child from tolerating exercise due to cardiovascular conditions
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 |
|---|---|---|
| Active video gamingChildren will visit Blythedale for 8 sessions, one 45-session visit per week, in place of one of the child's typical physical therapy sessions. During each session, children will play a video game on the X-Box Kinect system, using the games "Kinect Adventures" and "Kinect Sports". The child will first play a "Kinect Adventures" game, which requires ambulating, ducking, and dodging one's way through an obstacle course. | Behavioural | Video gaming |
| Usual care physical therapyChildren will attend their usual care physical therapy appointments at Blythedale. | Behavioural | Usual care |
Primary outcome
Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test
Time frame: From before intervention to immediately after intervention
The PEDI-CAT measures abilities in three functional domains: Daily Activities, Mobility and Social/Cognitive.
7 secondary outcomes
Change in 10 Meter walk test
Time frame: From before intervention to immediately after intervention
Change in Gross Motor Function Measure (GMFM) subtest D and E
Time frame: From before intervention to immediately after intervention
Change in Four Square Step Test
Time frame: From before intervention to immediately after intervention
Change in Functional Gait Assessment (FGA)
Time frame: From before intervention to immediately after intervention
Change in Motor Free Visual Perceptual Test (MVPT)-4
Time frame: From before intervention to immediately after intervention
Change in Visually guided weight shift ability as measured by the Smart Balance Master®
Time frame: From before intervention to immediately after intervention
Change in Children's Assessment of Participation and Enjoyment
Time frame: From before intervention to immediately after intervention
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 10 Jan 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active video gaming in people with Cerebral Palsy and Acquired Brain Injury, run by Blythedale Children's Hospital at 1 site in United States.
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 6 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 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 Pediatric Evaluation of Disability Inventory Computer Adaptive Test (time frame: From before intervention to immediately after 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 10 Jan 2022.