Training using virtual reality to improve walking and balance after brain injury
Personalized Cognitive Integrated Motor Training Using Virtual Reality to Improve Gait and Balance in People with Traumatic Brain Injury
This study is testing whether virtual reality training can help people with brain injuries improve their walking and balance better than standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Kessler Foundation Academic / other |
| Locations | 1 site (West Orange, New Jersey) |
| Trial ID | NCT06473987 on ClinicalTrials.gov |
What this trial studies
This research focuses on individuals with traumatic brain injury (TBI) who experience difficulties with walking and balance. It aims to evaluate the effectiveness of a novel training regimen that combines cognitive tasks with sensorimotor activities using virtual and augmented reality. Participants will be divided into three groups to compare personalized cognitive integrated sensorimotor training, traditional dual-task training, and standard care. The study will assess improvements in gait, balance, cognitive functions, and the underlying mechanisms of these changes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who have been living with TBI for at least six months and can follow directions.
Not a fit: Patients with uncontrolled medical issues, severe vision problems, or recent leg injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance walking and balance abilities in patients recovering from traumatic brain injury.
How similar studies have performed: Other studies have shown promise in using cognitive-motor training approaches, but this specific application with VR/AR is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be between 18-65 years of age. * Be a person living with TBI for at least 6 months. * Be able to follow directions and commands. * Be able to speak and understand English well as evaluated by a test I will be given by the researchers. * Not have amnesia (as determined by study staff based on a Post Traumatic Amnesia O-log score of \> 20 on 2 consecutive days) * Have approval from a physician to participate. * Have no history of injury or problems with my legs in the past 6 months or any medical issue which would interfere with my ability to bear weight on my legs and walk (such as a bone or muscle injury). * No double vision (diplopia) or other vision problems (such as nystagmus, as determined by study staff) * Have joint passive range of motion within normal functional limits for walking as determined by study staff. * Have a walking speed of less than 0.8 m/s as determined by study staff. * Be able to stand for 5 minutes. Exclusion Criteria: * I have uncontrolled or unstable seizure disorder (such as epilepsy). * I have pre-existing condition that makes it difficult for me to exercise (such as diagnosed high blood pressure that is not controlled, heart disease, irregular heart rate or rhythm, or congestive heart failure). * I have muscle or nervous system problems other than TBI (such as spinal cord injury, multiple sclerosis, or Parkinson's disease) * Have any joint or muscle tightness that would limit my movement while walking. * I have any medical issue that prevents me from supporting my weight (such as bone or muscle injuries, pain, or severe muscle spasms). * I have been diagnosed with cognitive (thinking) problems prior to TBI. * I have severe dizziness (Dizziness Handicap Inventory score greater than 54 (as measured by study staff). * I have skin issues that would prevent me from wearing a safety harness.
Where this trial is running
West Orange, New Jersey
- Kessler Foundation — West Orange, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Kiran K Karunakaran, PhD — Kessler Foundation
- Study coordinator: Kiran K Karunakaran, Ph.D.
- Email: kkarunakaran@kesslerfoundation.org
- Phone: 973-324-3590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.