Personalized Cognitive Integrated Motor Training Using Virtual Reality to Improve Gait and Balance
Part of paid clinical trials in West Orange, New Jersey.
- Sponsor
- Kessler Foundation
- Study ID
- NCT06473987
- Status
- Recruiting
Conditions
- Traumatic Brain Injury
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Personalized cognitive-sensorimotor VR/AR training — OTHERThinking task integrated walking and balance training program
- Traditional dual-task training — OTHERWalking and balance training similar to standard of care group but will also perform additional thinking tasks during training
- Standard of Care — OTHERStandard walking and balance training
Study Details
Problems with walking and balance are common after traumatic brain injury (TBI). Walking and balance problems limit independence and increase risk for injuries due to falls. The purpose of this research study is to test the effectiveness of training that combines moving and thinking tasks, referred to as Personalized cognitive integrated sensorimotor virtual reality (VR)/augmented reality (AR) training on walking and balance ability. The study will also help to understand the changes in thinking ability and brain activity as a result of this training after a brain injury. The study will evaluate the differences between three intervention groups (n=45 each): 1) personalized cognitive integrated sensorimotor VR/AR training (CMT), 2) traditional dual-task training (CTRL), and 3) standard of care (SOC) on gait, balance, community ambulation, and cognitive functions, as well as underlying biomechanical and neurophysiological mechanisms to understand the changes due to CMT.
Key Dates
- Start date
- Dec 1, 2024
- Status verified
- Sep 2024
- Primary completion
- Jul 31, 2028
- Completion
- Sep 29, 2028
Study Design
- Enrollment
- 135 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Personalized cognitive-sensorimotor VR/AR trainingThinking task integrated walking and balance training program
- Active Comparator: Traditional dual-task trainingWalking and balance training similar to standard of care group but will also perform additional thinking tasks during training.
- Active Comparator: Standard of CareStandard walking and balance training
Primary Outcome Measure
10 Meter walk test [ Time Frame: 10 weeks ]
Central Contacts
- Kiran K Karunakaran, Ph.D.973-324-3590
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Kessler Foundation | West Orange | New Jersey | 07052 | - |
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