Virtual Reality Training for Gait and Balance After Traumatic Brain Injury
This study is testing new ways to improve walking and balance for people who have had a traumatic brain injury (TBI). Many people with TBI have problems with walking and balance, which can make them less independent and increase their risk of falls. This research will compare three types of training: Personalized cognitive-sensorimotor VR/AR training (which uses virtual or augmented reality to combine thinking tasks with movement), Traditional dual-task training (which adds thinking tasks to standard walking and balance exercises), and Standard of Care (regular walking and balance training). The study aims to see how well these trainings improve walking and balance, and also how they affect thinking ability and brain activity. You may be able to join if you are 18-65 years old, have lived with TBI for at least 6 months, can follow directions, and speak and understand English well. The study is currently unclear on its recruitment status and plans to enroll 135 participants. Success will be measured by improvements in walking speed (10 Meter walk test), how quickly you can get up and go (Timed Up and Go), and overall balance (Berg balance Assessment) after 10 weeks.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 135 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your walking and balance will be measured at 10 weeks after the start of the training.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Personalized Cognitive Integrated Motor Training Using Virtual Reality to Improve Gait and Balance
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Kiran K Karunakaran, PhD · PRINCIPAL_INVESTIGATOR · Kessler Foundation
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 10 Meter walk test10 weeks
Participants will be asked to walk about 12 meters. The time taken to walk 10 meters will be recorded.
- Timed Up and Go (TUG)10 weeks
TUG is a clinical test of functional gait abilities and dynamic balance. The participants will be asked to walk a distance of 3 meters from a seated position, turn around, walk back to the chair and sit back in the chair. The time taken to perform the task will be recorded using a stop watch. The TUG will be repeated multiple times. The participant may be asked to hold a plastic cup or count backwards by three from a randomly selected number while walking.
- Berg balance Assessment:10 weeks
This is a test that measures balance on a 5-point during routine tasks. The participant will be asked to perform 14 tasks involving: sitting, standing, reaching, lifting, and turning.
- Digit Span (Wechsler Adult Intelligence Scale [WAIS-IV])10 weeks
This test assesses attention and working memory.
- Flanker Inhibitory Control and Attention Test10 weeks
This test assesses the allocation of limited attentional capacities to deal with an abundance of environmental stimulation. The test measures attention and the ability to inhibit response that may interfere with the ability to achieve goals.
- Symbol Digit Modalities Test (SDMT)10 weeks
This test assesses processing speed without a motor component
- Paced Auditory Serial Addition Test (PASAT)10 weeks
This test assesses information processing speed \& ability and working memory
- Letter-Number Sequencing (WAIS-IV)10 weeks
This test assesses working memory
- Delis-Kaplan Executive Function System10 weeks
Selected subtests to assess executive function.
- Hopkins Verbal Learning Test Revised10 weeks
This test assesses acquisition and delayed recall of verbal information.
- Temporal and spatial characteristics10 weeks
This test assess gait deviations and symmetry
- Fall Risk10 weeks
The silver index will be measured using the Hunova (Movendo Srl., Italy) to quantify the risk of falls. The Silver Index tasks include static balance while eyes are open or closed, dynamic balance while standing on passive and elastic surfaces, limits of stability, reactive balance during perturbations, 6-meter walk, and sit-to-stand.
- Balance10 weeks
Root-mean-square of COM and COP displacements will be used to quantify static and dynamic balance during Silver Index tasks. COP will be obtained from Hunova. Whole body COM will be obtained using motion capture.
- Neurophysiological- Maximum increase in O2Hb concentration in cortical regions10 weeks
The change in the hemoglobin concentration in response to a metabolic event (neuronal) such as walking is known as the hemodynamic response (HDR) of the brain. The maximum increase following a task will be quantified as net cortical responsivity to task using functional near infrared spectroscopy (fNIRS)
- Participation Objective, Participation Subjective (POPS)10 weeks
POPS assesses perspectives of the respondent regarding participation in home \& community, and societal/normative ("outsider") evaluation. POPS consists of 26 items sorted into 5 categories \[a) Domestic Life, b) Major Life Activities, c) Transportation, d) Interpersonal Interactions and Relationships, e) Community, Recreational and Civic Life\].
- Quality of Life after Brain Injury (QOLIBRI)10 weeks
This assesses QoL in people with TBI and is a 37-item scale with six subscales. The first part assesses "satisfaction level" with Health-related Quality of Life (HRQOL) and is composed of 6 overall items and 29 items assigned to 4 subscales: a) thinking, b) feelings and emotion, c) autonomy in daily life, and d) social aspects. The second part is devoted to "bothered" questions and composed of 12 items in 2 subscales: a) negative feelings, and b) restrictions. Responses to the 'satisfaction' items are coded on a 1 to 5 scale, where 1= "not at all satisfied" and 5= "very satisfied". Responses to the 'bothered' items are reverse scored to correspond with the satisfaction items, where 1=" very bothered" and 5= "not at all bothered".