Actively Recruiting
Personalized Cognitive Integrated Motor Training Using Virtual Reality to Improve Gait and Balance
Led by Kessler Foundation · Updated on 2024-11-27
135
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
Sponsors
K
Kessler Foundation
Lead Sponsor
M
Massachusetts General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Personalized Cognitive Integrated Motor Training Using Virtual Reality to Improve Gait and Balance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between 18-65 years of age.
- Living with traumatic brain injury for at least 6 months.
- Able to follow directions and commands.
- Able to speak and understand English well as evaluated by researchers.
- No amnesia as determined by a Post Traumatic Amnesia O-log score of more than 20 on 2 consecutive days.
- Have approval from a physician to participate.
- No injury or problems with legs in the past 6 months or any medical issue affecting ability to bear weight and walk.
- No double vision or other vision problems such as nystagmus as determined by study staff.
- Have joint passive range of motion within normal functional limits for walking.
- Walking speed less than 0.8 meters per second as determined by study staff.
- Able to stand for 5 minutes.
You will not qualify if you...
- Have uncontrolled or unstable seizure disorder such as epilepsy.
- Have a pre-existing condition that makes exercise difficult, like uncontrolled high blood pressure, heart disease, irregular heart rate, or congestive heart failure.
- Have muscle or nervous system problems other than traumatic brain injury, such as spinal cord injury, multiple sclerosis, or Parkinson's disease.
- Have any joint or muscle tightness that limits movement while walking.
- Have any medical issue preventing weight support, such as bone or muscle injuries, pain, or severe muscle spasms.
- Diagnosed with cognitive problems prior to traumatic brain injury.
- Have severe dizziness measured by a Dizziness Handicap Inventory score greater than 54.
- Have skin issues preventing wearing a safety harness.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kessler Foundation
West Orange, New Jersey, United States, 07052
Actively Recruiting
Research Team
K
Kiran K Karunakaran, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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