Recruiting

Cognitive Motor TrainingPersonalized Cognitive Integrated Motor Training Using Virtual Reality to Improve Gait and Balance

Sponsor:

Kessler Foundation

Code:

NCT06473987

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Personalized cognitive-sensorimotor VR/AR training

Traditional dual-task training

Standard of Care

Study Details

Brief 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.

Conditions

Traumatic Brain Injury

Study ID

NCT06473987

Start date

Dec 1, 2024

Status verified date

Sep, 2024

Completion date

Sep 29, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

135 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Personalized cognitive-sensorimotor VR/AR training

Thinking task integrated walking and balance training program

Traditional dual-task training

Walking and balance training similar to standard of care group but will also perform additional thinking tasks during training

Standard of Care

Standard walking and balance training

Primary outcome measure

10 Meter walk test [ Time Frame: 10 weeks ]
Timed Up and Go (TUG) [ Time Frame: 10 weeks ]
Berg balance Assessment: [ Time Frame: 10 weeks ]
Digit Span (Wechsler Adult Intelligence Scale [WAIS-IV]) [ Time Frame: 10 weeks ]
Flanker Inhibitory Control and Attention Test [ Time Frame: 10 weeks ]
Symbol Digit Modalities Test (SDMT) [ Time Frame: 10 weeks ]
Paced Auditory Serial Addition Test (PASAT) [ Time Frame: 10 weeks ]
Letter-Number Sequencing (WAIS-IV) [ Time Frame: 10 weeks ]
Delis-Kaplan Executive Function System [ Time Frame: 10 weeks ]
Hopkins Verbal Learning Test Revised [ Time Frame: 10 weeks ]
Temporal and spatial characteristics [ Time Frame: 10 weeks ]
Fall Risk [ Time Frame: 10 weeks ]
Balance [ Time Frame: 10 weeks ]
Neurophysiological- Maximum increase in O2Hb concentration in cortical regions [ Time Frame: 10 weeks ]
Participation Objective, Participation Subjective (POPS) [ Time Frame: 10 weeks ]
Quality of Life after Brain Injury (QOLIBRI) [ Time Frame: 10 weeks ]

Central Contacts and Locations

Central contacts

Kiran K Karunakaran, Ph.D.

973-324-3590 kkarunakaran@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

More Information

Sponsor

Kessler Foundation

Last update posted

Nov 27, 2024

Last verified

Sep, 2024

Keywords

Traumatic Brain Injury
Gait
Balance
Cognition
Ambulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2024-11-27.