Training using virtual reality to improve walking and balance after brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.