Traumatic Brain InjuryCMTNCT06473987
Personalized Cognitive Integrated Motor Training Using Virtual Reality to Improve Gait and Balance
A study testing Personalized cognitive-sensorimotor VR/AR training and Traditional dual-task training in people with Traumatic Brain Injury, run by Kessler Foundation at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Personalized cognitive-sensorimotor VR/AR training and Traditional dual-task training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 29 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
About this study
Official title: Personalized Cognitive Integrated Motor Training Using Virtual Reality to Improve Gait and Balance in People with Traumatic Brain Injury
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.
Read the detailed description
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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Personalized cognitive-sensorimotor VR/AR training, Traditional dual-task training, Standard of Care
- Keywords
- Traumatic Brain Injury, Gait, Balance, Cognition, Ambulation
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized cognitive-sensorimotor VR/AR trainingOther
Also called cognitive-motor training
Thinking task integrated walking and balance training program
Traditional dual-task trainingOther
Also called Dual task training
Walking and balance training similar to standard of care group but will also perform additional thinking tasks during training
Standard of CareOther
Also called conventional training
Standard walking and balance training
| Study group | Role | What they receive |
|---|---|---|
| Personalized cognitive-sensorimotor VR/AR training | Experimental | Thinking task integrated walking and balance training program Receives: Other: Personalized cognitive-sensorimotor VR/AR training |
| Traditional dual-task training | Active comparator | Walking and balance training similar to standard of care group but will also perform additional thinking tasks during training. Receives: Other: Traditional dual-task training |
| Standard of Care | Active comparator | Standard walking and balance training Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 Meter walk test
Participants will be asked to walk about 12 meters. The time taken to walk 10 meters will be recorded.
Measured: 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.
Measured: 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.
Measured: 10 weeks
Digit Span (Wechsler Adult Intelligence Scale [WAIS-IV])
This test assesses attention and working memory.
Measured: 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.
Measured: 10 weeks
Symbol Digit Modalities Test (SDMT)
This test assesses processing speed without a motor component
Measured: 10 weeks
Paced Auditory Serial Addition Test (PASAT)
This test assesses information processing speed \& ability and working memory
Measured: 10 weeks
Letter-Number Sequencing (WAIS-IV)
This test assesses working memory
Measured: 10 weeks
Delis-Kaplan Executive Function System
Selected subtests to assess executive function.
Measured: 10 weeks
Hopkins Verbal Learning Test Revised
This test assesses acquisition and delayed recall of verbal information.
Measured: 10 weeks
Temporal and spatial characteristics
This test assess gait deviations and symmetry
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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].
Measured: 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".
Measured: 10 weeks
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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).
Measured: 10 weeks
Area under the curve (AOC)
AOC of O2Hb for each region of interest will be computed
Measured: 10 weeks
minimum change in O2Hb
The minimum change following a task will be quantified using fNIRS.
Measured: 10 weeks
functional connectivity
Functional connectivity between channels during rest and walking will be evaluated.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion29 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Kiran K Karunakaran, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473987
- Sponsor's protocol ID
- R-1262-24
- Other IDs
- TP230307
- Acronym
- CMT
- Status last verified
- Sep 2024
- First submitted
- 19 Jun 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Cognitive Integrated Motor Training Using Virtual Reality to Improve Gait and Balance in People with Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06473987
- Acronym / sponsor ID
- CMT / R-1262-24
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Gait, Balance, Cognition, Ambulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 29 Sep 2028 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Personalized cognitive-sensorimotor VR/AR training | Experimental | Other: Personalized cognitive-sensorimotor VR/AR trainingThinking task integrated walking and balance training program |
| Traditional dual-task training | Active comparator | Other: Traditional dual-task trainingWalking and balance training similar to standard of care group but will also perform additional thinking tasks during training. |
| Standard of Care | Active comparator | Other: Standard of CareStandard walking and balance training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized cognitive-sensorimotor VR/AR trainingAlso: cognitive-motor trainingThinking task integrated walking and balance training program | Other | Personalized cognitive-sensorimotor VR/AR training |
| Traditional dual-task trainingAlso: Dual task trainingWalking and balance training similar to standard of care group but will also perform additional thinking tasks during training | Other | Traditional dual-task training |
| Standard of CareAlso: conventional trainingStandard walking and balance training | Other | Standard of Care |
Primary outcome
10 Meter walk test
Time frame: 10 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)
Time frame: 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:
Time frame: 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])
Time frame: 10 weeks
This test assesses attention and working memory.
Flanker Inhibitory Control and Attention Test
Time frame: 10 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)
Time frame: 10 weeks
This test assesses processing speed without a motor component
Paced Auditory Serial Addition Test (PASAT)
Time frame: 10 weeks
This test assesses information processing speed \& ability and working memory
Letter-Number Sequencing (WAIS-IV)
Time frame: 10 weeks
This test assesses working memory
Delis-Kaplan Executive Function System
Time frame: 10 weeks
Selected subtests to assess executive function.
Hopkins Verbal Learning Test Revised
Time frame: 10 weeks
This test assesses acquisition and delayed recall of verbal information.
Temporal and spatial characteristics
Time frame: 10 weeks
This test assess gait deviations and symmetry
Fall Risk
Time frame: 10 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.
Balance
Time frame: 10 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 regions
Time frame: 10 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)
Time frame: 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)
Time frame: 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".
9 secondary outcomes
6 Minute Walk Test
Time frame: 10 weeks
Dynamic Gait Index (DGI)
Time frame: 10 weeks
Walking While Talking Test
Time frame: 10 weeks
Area under the curve (AOC)
Time frame: 10 weeks
minimum change in O2Hb
Time frame: 10 weeks
functional connectivity
Time frame: 10 weeks
Electromyography
Time frame: 10 weeks
Community Integration Questionnaire (CIT)
Time frame: 10 weeks
Patient Competency Rating Scale (PCRS)
Time frame: 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kiran K Karunakaran, PhD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized cognitive-sensorimotor VR/AR training and Traditional dual-task training in people with Traumatic Brain Injury, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kiran K Karunakaran, Ph.D. (973-324-3590, kkarunakaran@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10 Meter walk test (time frame: 10 weeks). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.