ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03386968
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
Blythedale Children's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Acquired Brain Injury Behavioral: Active video gaming Behavioral: Usual care physical therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : December 7, 2017
Estimated Primary Completion Date : December 6, 2019
Estimated Study Completion Date : December 6, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
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.
Active Comparator: Usual care
Children will receive their usual care in the physical therapy program at Blythedale.
Behavioral: Usual care physical therapy
Children will attend their usual care physical therapy appointments at Blythedale.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in 10 Meter walk test [ Time Frame: From before intervention to immediately after intervention ]
    Measures time taken for a participant to walk 10 meters

  2. Change in Gross Motor Function Measure (GMFM) subtest D and E [ Time Frame: From before intervention to immediately after intervention ]
    The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy.

  3. Change in Four Square Step Test [ Time Frame: From before intervention to immediately after intervention ]
    Measures how well a patient can change directions while stepping.

  4. Change in Functional Gait Assessment (FGA) [ Time Frame: From before intervention to immediately after intervention ]
    10-item test that assesses dynamic balance and postural stability during gait.

  5. Change in Motor Free Visual Perceptual Test (MVPT)-4 [ Time Frame: From before intervention to immediately after intervention ]
    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.

  6. Change in Visually guided weight shift ability as measured by the Smart Balance Master® [ Time Frame: From before intervention to immediately after intervention ]
    Force platform system that tests balance

  7. Change in Children's Assessment of Participation and Enjoyment [ Time Frame: From before intervention to immediately after intervention ]
    Self-report measures of children's participation in recreation and leisure activities outside of mandated school activities.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386968


Contacts
Contact: Teresa Smith, MSPT 914-592-7555 ext 71790 teresas@blythedale.org

Locations
United States, New York
Blythedale Children's Hospital Recruiting
Valhalla, New York, United States, 10595
Contact: Linda Fieback, PT    914-592-7138    lindaf@blythedale.org   
Sub-Investigator: Mark Felsenfeld, PT         
Sub-Investigator: Teresa Smith, PT         
Sponsors and Collaborators
Blythedale Children's Hospital

Responsible Party: Blythedale Children's Hospital
ClinicalTrials.gov Identifier: NCT03386968     History of Changes
Other Study ID Numbers: 17-1206TS
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Blythedale Children's Hospital:
virtual reality
hemiplegia
diplegia
video gaming
active video games
Playstation X-Box 360
Rutgers V-Step
Microsoft Kinect

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Cerebral Palsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Brain Damage, Chronic