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 — OTHER
    Thinking task integrated walking and balance training program
  • Traditional dual-task training — OTHER
    Walking and balance training similar to standard of care group but will also perform additional thinking tasks during training
  • Standard of Care — OTHER
    Standard 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 training
    Thinking task integrated walking and balance training program
  • Active Comparator: Traditional dual-task training
    Walking and balance training similar to standard of care group but will also perform additional thinking tasks during training.
  • Active Comparator: Standard of Care
    Standard walking and balance training

Primary Outcome Measure

10 Meter walk test [ Time Frame: 10 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kessler FoundationWest OrangeNew Jersey07052-

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