Personalized Cognitive Integrated Motor Training Using Virtual Reality to Improve Gait and Balance in People with Traumatic Brain Injury

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
United States
New Jersey
Kessler Foundation
RECRUITING
West Orange
Contact Information
Primary
Kiran K Karunakaran, Ph.D.
kkarunakaran@kesslerfoundation.org
973-324-3590
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2028-09-29
Participants
Target number of participants: 135
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Kessler Foundation
Collaborators: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov