An interventional study of Personalized cognitive-sensorimotor VR/AR training and Traditional dual-task training in Traumatic Brain Injury, sponsored by Kessler Foundation. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by Kessler Foundation · Not applicable, Interventional, and Treatment
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.
Traumatic brain injury (TBI) affects 2.87 million people annually in the US and is a leading cause of long-term disability. TBI impairs both cognitive and sensorimotor functions, with debilitating consequences on ambulation (gait \& balance), which persist during the chronic stages of recovery. Individuals with TBI-induced gait \& balance dysfunction are at a higher risk of falls leading to another TBI. Gait \& balance control is a complex interplay between various cognitive and motor processes, and disruption of any of these processes can severely affect gait \& balance and result in falls. Research examining TBI-related changes in cognitive demands associated with gait \& balance control has shown increased cognitive demand to perform gait \& balance tasks in individuals with TBI, with increases in cognitive demand for more complex tasks. This strong link between cognitive (attention, processing speed \& executive function) and sensorimotor functions is the basis for the proposed project. The investigators aim to strengthen this inseparable link using a novel cognitive-motor intervention.
The investigators propose a training regimen, cognitive integrated sensorimotor training (CMT), which increases the cognitive-motor effort to perform the tasks. CMT uses virtual and augmented reality (VR/AR) to employ the cognitive system to perform the motor task in order to train the inseparable cognitive and motor components that are critically important for gait \& balance function. Here the cognitive task is "incorporated" into the motor task, as the cognitive task is a relevant prerequisite for successfully completing the sensorimotor task. The investigators hypothesize that CMT will maximize gait \& balance function and reduce falls in adults with TBI.
The study will evaluate the differences between three intervention groups (n=45 each): a) personalized cognitive integrated sensorimotor VR/AR training (CMT), b) traditional dual-task training (CTRL), and c) 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.
1,818 studies on the registry are indexed under Brain Injuries, Traumatic; 460 are open to participants now.
This study's planned enrollment of 135 is above the median of 55 across 1,158 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Kessler Foundation is the lead sponsor of 174 studies on the registry; 60 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Thinking task integrated walking and balance training program
Other: Personalized cognitive-sensorimotor VR/AR training
Walking and balance training similar to standard of care group but will also perform additional thinking tasks during training.
Other: Traditional dual-task training
Standard walking and balance training
Other: Standard of Care
Thinking task integrated walking and balance training program
Also known as: cognitive-motor training
Walking and balance training similar to standard of care group but will also perform additional thinking tasks during training
Also known as: Dual task training
Standard walking and balance training
Also known as: conventional training
10 Meter walk test
Participants will be asked to walk about 12 meters. The time taken to walk 10 meters will be recorded.
Time frame: 10 weeks
Timed Up and Go (TUG)
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.
Time frame: 10 weeks
Berg balance Assessment:
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.
Time frame: 10 weeks
Digit Span (Wechsler Adult Intelligence Scale [WAIS-IV])
This test assesses attention and working memory.
Time frame: 10 weeks
Flanker Inhibitory Control and Attention Test
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.
Time frame: 10 weeks
Symbol Digit Modalities Test (SDMT)
This test assesses processing speed without a motor component
Time frame: 10 weeks
Paced Auditory Serial Addition Test (PASAT)
This test assesses information processing speed \& ability and working memory
Time frame: 10 weeks
Letter-Number Sequencing (WAIS-IV)
This test assesses working memory
Time frame: 10 weeks
Delis-Kaplan Executive Function System
Selected subtests to assess executive function.
Time frame: 10 weeks
Hopkins Verbal Learning Test Revised
This test assesses acquisition and delayed recall of verbal information.
Time frame: 10 weeks
Temporal and spatial characteristics
This test assess gait deviations and symmetry
Time frame: 10 weeks
Fall Risk
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.
Time frame: 10 weeks
Balance
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.
Time frame: 10 weeks
Neurophysiological- Maximum increase in O2Hb concentration in cortical regions
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)
Time frame: 10 weeks
Participation Objective, Participation Subjective (POPS)
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 \[a) Domestic Life, b) Major Life Activities, c) Transportation, d) Interpersonal Interactions and Relationships, e) Community, Recreational and Civic Life\].
Time frame: 10 weeks
Quality of Life after Brain Injury (QOLIBRI)
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".
Time frame: 10 weeks
6 Minute Walk Test
Participants walk as far as possible for 6 minutes. They walk back and forth around the cones along an unobstructed pathway of 15 meters. They will be permitted to slow down or stop as necessary. The distance covered by the participant for the 6 minutes will be recorded at an interval of every 30 seconds using a measuring wheel and stop watch.
Time frame: 10 weeks
Dynamic Gait Index (DGI)
DGI is a measurement tool commonly used to assess dynamic balance, gait and risk for falls29. It consists of a total of eight gait assessments which can be scored on a four-point ordinal scale, ranging from 0-3, where '0' indicates the lowest level of function and '3' the highest level of function, allowing for a total possible score of 24.
Time frame: 10 weeks
Walking While Talking Test
The participants walk 20 ft, turn, and return while reciting the alphabet aloud from a given alphabet (simple) or alternate alphabets (complex).
Time frame: 10 weeks
Area under the curve (AOC)
AOC of O2Hb for each region of interest will be computed
Time frame: 10 weeks
minimum change in O2Hb
The minimum change following a task will be quantified using fNIRS.
Time frame: 10 weeks
functional connectivity
Functional connectivity between channels during rest and walking will be evaluated.
Time frame: 10 weeks
Electromyography
Electromygraphy (EMG) will be recorded as a complementary measure to fNIRS. Bilateral muscle responses from lower extremities will be recorded via surface EMG.
Time frame: 10 weeks
Community Integration Questionnaire (CIT)
The questionnaire is used to assess the societal role limitations and community integration of people with TBI. The CIT contains 15 items assessing community integration across three domains: a) Home integration (10 Points), b) Social integration (12 points), and c) Productive activity (7 points). Total scores ranges from 0 to 29 points. High scores represent greater independence and community integration.
Time frame: 10 weeks
Patient Competency Rating Scale (PCRS)
Instrument to assess the ability to perform a variety of activities, skills, and tasks. PCRS is a 30-item self-report that asks the person with TBI to rank their ability to accomplish common daily activities (ADL, behavioral and emotional functions, cognitive and physical abilities) on a 5-point scale. An informant (relative, caregiver, or therapist) also rates the person with TBI on the same items.
Time frame: 10 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Dec 2024; primary completion for Jul 2028, 43 months later.
Of 491 non-industry interventional studies with no phase under Brain Injuries, Traumatic, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 64. This study's planned 43 months is above that.
Counting every sponsor, half of 515 studies reached it within 36 months; a quarter within 21 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.