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CompletedNCT03386968Updated Jan 10, 2022

Virtual Reality and Active Video Games to Improve Balance in Children With Brain Injury

An interventional study of Active video gaming and Usual care physical therapy in Cerebral Palsy and Acquired Brain Injury, sponsored by Blythedale Children's Hospital. Completed at 1 site in United States. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-01-10.

Sponsored by Blythedale Children's Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Randomized
Ages
7 Years to 17 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 372 studies in Cerebral Palsy with a site in United States — 76 open to participants now, 105 under way, none of them phase 3. Cerebral Palsy · United States.

Enrollment
271st of 296
4 · median 25
Started
2017
with 13 others
No phase
218 of 372
49 open now
Registered
162nd of 372
by date

Among the 372 studies in Cerebral Palsy with a site in United States, this one is the 271st largest by enrollment of the 296 interventional ones that give a count, is one of 14 that started in 2017, is one of 218 with no phase, and was the 162nd registered.

Cerebral Palsy

1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.

This study's enrollment of 4 is below the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Open to participants now

76 of the 372 studies in Cerebral Palsy with a site in United States are open now.

All 76 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 270 Cerebral Palsy studies recruiting now, 27 (10%) set no upper age limit and 235 (87%) stop at 75 or younger; 255 take children under 18; 51 take healthy volunteers.

This study: 7 Years to 17 Years · all sexes · no healthy volunteers.

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02

Study 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 Cerebral Palsy (CP) hemiparesis or spastic diplegia, or non-progressive brain injury (BI). Children will be assessed using perceptual, balance, functional and gait assessments.

03

Conditions studied

  • Cerebral Palsy
  • Acquired Brain Injury

Keywords

  • virtual reality
  • hemiplegia
  • diplegia
  • video gaming
  • active video games
  • Playstation X-Box 360
  • Rutgers V-Step
  • Microsoft Kinect
04

Who can participate

Ages eligible
7 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    Video gaming

    A child's usual physical therapy session will be replaced with a session utilizing Active video games and the Rutger's V-step.

    Behavioral: Active video gaming

  • Active comparator
    Usual care

    Children will receive their usual care in the physical therapy program at Blythedale.

    Behavioral: Usual care physical therapy

Interventions

  • BehavioralActive video gaming

    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.

  • BehavioralUsual care physical therapy

    Children will attend their usual care physical therapy appointments at Blythedale.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From before intervention to immediately after intervention

Secondary outcomes

  1. Change in 10 Meter walk test

    Measures time taken for a participant to walk 10 meters

    Time frame: From before intervention to immediately after intervention

  2. 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.

    Time frame: From before intervention to immediately after intervention

  3. Change in Four Square Step Test

    Measures how well a patient can change directions while stepping.

    Time frame: From before intervention to immediately after intervention

  4. Change in Functional Gait Assessment (FGA)

    10-item test that assesses dynamic balance and postural stability during gait.

    Time frame: From before intervention to immediately after intervention

  5. 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.

    Time frame: From before intervention to immediately after intervention

  6. Change in Visually guided weight shift ability as measured by the Smart Balance Master®

    Force platform system that tests balance

    Time frame: From before intervention to immediately after intervention

  7. 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.

    Time frame: From before intervention to immediately after intervention

07

Study locations

1 site
  • Blythedale Children's Hospital
    Valhalla, New York 10595, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Jan 2022, 48 months.

Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 48 months is above that.

Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 7, 2017
First posted
Dec 29, 2017
StartActual
Dec 7, 2017
Primary completionActual
Jan 6, 2022
CompletionActual
Jan 6, 2022
Last update
Jan 10, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03386968
Lead sponsor
Blythedale Children's Hospital
Responsible party
Sponsor
First posted
Dec 29, 2017
Start date
Dec 7, 2017
Primary completion
Jan 6, 2022
Completion
Jan 6, 2022
Last update
Jan 10, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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