Traumatic Brain InjuryNCT06584591
NEUROBALANCE Training to Improve Postural Control in Individuals With Traumatic Brain Injury
A study testing Combined (Robotic balance training and high-definition transcranial direct current stimulation) in people with Traumatic Brain Injury and TBI, run by Kessler Foundation at 1 site in United States.
Trial summary
Our proposed study, \"NEUROBALANCE,\" aims to evaluate the effectiveness of a combined intervention involving robotic balance training and noninvasive brain stimulation in improving balance functions in individuals with chronic traumatic brain injury (TBI). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Traumatic Brain Injury, TBI, Diffuse Axonal Brain Injury
- What is being tested?
- Combined (Robotic balance training and high-definition transcranial direct current stimulation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to Dec 2027
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18-75 years
- Diagnosed with a non-penetrating TBI at least six months before the screening.
- Have complaints of impaired balance and poor postural control determined by a BBS score of ≤50.
- Ability to stand upright with or without support for at least 20 seconds
- Ability to walk with or without a walking aid for at least ten meters
- Not planning to change medication in the next four months
- Minimum Cognitive Ability to understand the verbal instructions and comply with the study procedures, as determined by the University of California, San Diego, Brief Assessment of Capacity to Consent Instrument (UBACC).
Who cannot join
- Currently undergoing any regular physical therapy program or research studies focusing on balance functions.
- Having a stroke or a penetrating TBI.
- Affected by the peripheral nerve injury, neuromuscular conditions, or orthopedic issues of lower limbs before TBI, or have any persistent pain or difficulty maintaining blood pressure while upright.
- Have a scalp or skin condition (e.g., psoriasis or eczema) on the scalp near the stimulation site.
- Severe visual impairment (e.g., spatial neglect) or hearing problems may affect study compliance.
- Any other neurological injury or psychiatric conditions (e.g., severe anxiety or schizophrenia, etc.)
Show all 9Show fewer
- Not being pregnant or thinking of becoming pregnant during the study period.
- Diagnosed with alcohol or substance abuse in the last three years.
- Contraindications to TMS, including the presence of metallic implants in the head and history of seizures or medication-resistant epilepsy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kathleen Goworek, B.S. contact
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Vikram Shenoy Handiru, Ph.D.
Kiran Karunakaran, Ph.D.
About this study
Official title: Neuromodulation-Enhanced Use of RObotic Balance Training to Improve Postural Control in Individuals With Traumatic Brain Injury
Our proposed study, \"NEUROBALANCE,\" aims to evaluate the effectiveness of a combined intervention involving robotic balance training and noninvasive brain stimulation in improving balance functions in individuals with chronic traumatic brain injury (TBI). The study will recruit 45 participants who have had a TBI for over six months and experience persistent balance deficits. Participants will be randomized into three groups: (1) robotic balance training with active brain stimulation, (2) robotic balance training with sham brain stimulation, and (3) standard-of-care rehabilitation.
The study will involve 12 training sessions over four weeks, with assessments conducted at baseline, post-training, and two months post-training to evaluate balance recovery and retention. The primary focus is understanding how this intervention affects brain and muscle activity during balance tasks and how these changes translate into functional improvements in clinical outcome measures of balance function. Additionally, participant feedback on brain stimulation and exercise engagement will be collected to inform future studies.
This research is particularly relevant to military service members, as TBI and balance impairments are common among this population. The findings may guide the development of personalized training protocols and contribute to broader rehabilitation strategies.
Read the detailed description
Background: Traumatic Brain Injury (TBI) is one of the severe health conditions with debilitating consequences, affecting more than 2.5 million individuals in the US alone. Balance dysfunction is one of the most disabling outcomes of TBI, affecting roughly half of those who have TBI even after ten years have passed after their accident, and further, it increases the risk of falls due to poor postural control. The current challenges are that there are currently no well-established rehabilitation treatments that have been shown to have long-term retention of balance recovery in TBI survivors with chronic balance complaints. Therefore, we need novel therapeutic strategies using rehabilitation engineering that can target sensorimotor integration and improved proprioceptive control to improve balance function, thereby alleviating the long-term burden on TBI survivors and their caregivers.
Hypothesis and Rationale: We hypothesize that the balance and postural control recovery requires a multimodal strategy, and we propose robotic balance training (RBT) using the Hunova platform (Movendo Technology, Italy), as it has an advantage of supporting dynamic balance in not only sagittal plane but also transverse plane (mediolateral and anterior-posterior directions), and allows for core stability and trunk control with its unique seated balance exercises. In addition, we hypothesize that by using high-definition transcranial direct current stimulation (HD-tDCS) as an adjuvant to RBT, HD-tDCS will facilitate top-down neuromuscular control of balance through corticospinal circuits, whereas the robotic platform will enable bottom-up feedback of response to platform perturbations. Overall, we anticipate that the combined intervention will improve reactive and anticipatory postural control, position sense, and proprioceptive control, gain lower-limb strength, increase ankle range of motion, and stimulate attention through game-like exercises.
Study Design: We propose a single-center, investigator-blinded, randomized, sham-controlled triple-arm parallel-group, superiority trial study. Forty-five adult individuals with chronic TBI with complaints of balance dysfunction (injury onset \> 6 months before screening) will be randomized into one of the three groups: (1) Real HD-tDCS + RBT, (2) Sham HD-tDCS + RBT, and (3) Control group receiving dose-matched standard of care rehabilitation treatment. All participants will undergo 12 sessions (3 days × 4 weeks) of intervention. A total of 3 assessment visits (before training, immediately after 4-week training, and 2-months after the last training visit) will be conducted to evaluate the functional recovery and neurophysiological changes due to intervention.
Specific Aim-1: To determine whether there is an overall treatment effect of targeted neuromodulation combined with robotic balance training on balance outcomes immediately after 4-week training function in people with TBI. The change in Berg Balance Scale score from baseline to 4-week post-training will be the primary outcome measure. The secondary outcome measures of balance recovery will be the changes in Mini BESTest, Functional Gait Assessment, and Trunk Impairment Scale scores from baseline to 4-week post-training. We hypothesize that the Real HD-tDCS + RBT will show the largest improvement in the balance outcomes.
Secondary Aim-2: To characterize the top-down and bottom-up neurophysiological mechanisms of balance control due to neuromodulation-enhanced robotic training. We will measure the neurophysiological outcomes of EEG and EMG activity, and posturography outcomes of body sway during platform perturbation task at baseline, 4-week post-training, and 2-month follow-up. Specifically, the intervention-induced changes in the cortical reactivity amplitude, muscle coactivation, and center of displacement will be compared across groups.
Secondary Aim-3: To study the association between the intervention-related changes in the balance function endpoints and graph-theoretic measures of cortical functional connectivity. We will use a multivariate statistical approach-partial least squares correlation-to identify a latent component that characterizes the correlation between the 4-week intervention-related changes in balance outcome measures and EEG corticocortical functional connectivity features measured during platform perturbation task.
- Being tested
- Combined (Robotic balance training and high-definition transcranial direct current stimulation), Standard of Care Balance Training
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined (Robotic balance training and high-definition transcranial direct current stimulation)Device
The robotic platform will train the participants to maintain dynamic balance in the sagittal and the transverse planes (mediolateral and anterior-posterior directions) and engage in core stability and trunk control with seated balance exercises. In addition, high-definition transcranial direct current stimulation (HD-tDCS) will be used as an adjuvant to robotic balance training by priming the corticospinal circuits.
Standard of Care Balance TrainingOther
Participants in this group will receive a standard-of-care balance training administered by the Physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| RBT + Active HD-tDCS Group | Experimental | Participants will engage in balance and postural control training on a robotic balance platform called Hunova (Movendo, Italy). Before balance training, the current intensity of 2 mA will be delivered to the leg motor area identified using neuronavigated transcranial magnetic stimulation, and the stimulation will be turned ON for 20 minutes. Receives: Device: Combined (Robotic balance training and high-definition transcranial direct current stimulation) |
| RBT + Sham HD-tDCS Group | Sham comparator | Participants will engage in balance and postural control training on a robotic balance platform called Hunova (Movendo, Italy). Before balance training, the current intensity of 2 mA will be delivered to the leg motor area identified using neuronavigated transcranial magnetic stimulation, and the stimulation will be turned ON transiently for 30 s, to provide a sensation of stimulation. Receives: Device: Combined (Robotic balance training and high-definition transcranial direct current stimulation) |
| SOC Control Group | Other | The SOC control group participants will perform conventional physical therapy exercises delivered by a trained PT. Receives: Other: Standard of Care Balance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (BBS)
A widely used outcome measure of static standing balance function (Newstead et al., 2005), categorized under the 'Activity' subsection of ICF domain. BBS scores range from 0 to 56 (the higher, the better). The change in BBS scores from baseline to 4 weeks post-training will be the primary endpoint.
Measured: Baseline, post 4-week training, 2-month follow-up
Secondary outcomes (11)
Functional Gait Assessment (FGA)
To assess dynamic balance during walking, unlike BBS, it is not prone to the ceiling effect(Van Bloemendaal et al., 2019). FGA will be used as the secondary outcome measure of balance function and gait. FGA comes under the ICF domains of 'Activity' and 'Body Function.'
Measured: Baseline, post 4-week training, and 2-month follow-up
Mini Balance Evaluation Systems Test (MBT)
To identify the risk of falls (Yingyongyudha et al., 2016) with a high internal consistency with BBS and similar advantage of FGA, i.e., no ceiling effect. MBT will be used as the secondary endpoint of the balance function.
Measured: Baseline, post 4-week training, and 2-month follow-up
Trunk Impairment Scale (TIS)
To estimate the trunk motor impairment(Verheyden et al., 2004). The scale ranges from 0 to 23 and assesses static and dynamic postural control.
Measured: Baseline, post 4-week training, and 2-month follow-up
Center of Pressure (COP) Displacement
To evaluate the body sway in response to the perturbations of the posturography platform.
Measured: Baseline, post 4-week training, and 2-month follow-up
TMS-evoked EEG Potentials (TEP)
A neurophysiological outcome measure of cortical reactivity. TEPs can directly measure cortical reactivity without being affected by the distal components of the nervous system, especially in neurological populations(Keser et al., 2022). In contrast to motor-evoked potentials, TEPs also offer the advantage of eliciting cortical responses at TMS intensity below the resting motor threshold.
Measured: Baseline, post 4-week training, and 2-month follow-up
EEG Corticocortical Functional Connectivity
The imaginary part of coherence (iCOH) measured from the source-space EEG time-series will be used as an outcome measure of corticocortical connectivity, representing sensorimotor functional integration.
Measured: Baseline, post 4-week training, and 2-month follow-up
EEG-to-EMG Corticomuscular Connectivity
EEG-to-EMG directed transfer function (DTF) will be used as an outcome measure of causal information flow from cortical areas to the leg muscles (Artoni et al., 2017; Peterson \& Ferris, 2019). This measure is intended to capture changes in the efferent communication due to combined interventions.
Measured: Baseline, post 4-week training, and 2-month follow-up.
EMG Muscle Coactivation
EMG co-contraction index will be used as an outcome measure of muscle activation between the antagonist and agonist muscle pair involved in reactive balance control.
Measured: Baseline, post 4-week training, and 2-month follow-up.
Quality of Life after Brain Injury (QOLIBRI)
A 37-item questionnaire to assess the level of satisfaction with different aspects of Quality of Life (QoL), on a scale of 1 (not at all satisfied) to 5(very satisfied); QOLIBRI is categorized under the ICF domain of 'Participation.'
Measured: Baseline, post 4-week training, and 2-month follow-up.
Physical Activity Enjoyment Scale (PACES)
An 18-item questionnaire with a 7-point Likert scale (higher scores represent increased activity enjoyment) has high reliability and validity(Murrock et al., 2016). The PACES scores will be used during training to assess the enjoyability of the balance exercises.
Measured: Post 4-week training
Dizziness Handicap Inventory (DHI)
A 25-item questionnaire with a 3-point scale to evaluate how dizziness or unsteadiness has affected daily activities in the last month. (Jacobson \& Newman, 1990).
Measured: Baseline, post 4-week training, and 2-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start1 Aug 2025
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (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.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Vikram Shenoy Handiru, Kessler Foundation
- Investigators
- Vikram Shenoy Handiru, Ph.D., Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584591
- Sponsor's protocol ID
- R-1261-24
- Status last verified
- Aug 2025
- First submitted
- 2 Sep 2024
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: We will submit the IPD available in the tabular data to the Open Data Commons for Traumatic Brain Injury (ODC-TBI) after removing any personal or private identifiers. The neurophysiological data (such as the EEG, TMS, and EMG) will be shared on OpenNeuro.org (or a similar platform) in a BIDS-standardized format.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation-Enhanced Use of RObotic Balance Training to Improve Postural Control in Individuals With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06584591
- Acronym / sponsor ID
- R-1261-24
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Sep 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.
Our proposed study, \"NEUROBALANCE,\" aims to evaluate the effectiveness of a combined intervention involving robotic balance training and noninvasive brain stimulation in improving balance functions in individuals with chronic traumatic brain injury (TBI). The study will recruit 45 participants who have had a TBI for over six months and experience persistent balance deficits. Participants will be randomized into three groups: (1) robotic balance training with active brain stimulation, (2) robotic balance training with sham brain stimulation, and (3) standard-of-care rehabilitation.
The study will involve 12 training sessions over four weeks, with assessments conducted at baseline, post-training, and two months post-training to evaluate balance recovery and retention. The primary focus is understanding how this intervention affects brain and muscle activity during balance tasks and how these changes translate into functional improvements in clinical outcome measures of balance function. Additionally, participant feedback on brain stimulation and exercise engagement will be collected to inform future studies.
This research is particularly relevant to military service members, as TBI and balance impairments are common among this population. The findings may guide the development of personalized training protocols and contribute to broader rehabilitation strategies.
Detailed description
Background: Traumatic Brain Injury (TBI) is one of the severe health conditions with debilitating consequences, affecting more than 2.5 million individuals in the US alone. Balance dysfunction is one of the most disabling outcomes of TBI, affecting roughly half of those who have TBI even after ten years have passed after their accident, and further, it increases the risk of falls due to poor postural control. The current challenges are that there are currently no well-established rehabilitation treatments that have been shown to have long-term retention of balance recovery in TBI survivors with chronic balance complaints. Therefore, we need novel therapeutic strategies using rehabilitation engineering that can target sensorimotor integration and improved proprioceptive control to improve balance function, thereby alleviating the long-term burden on TBI survivors and their caregivers.
Hypothesis and Rationale: We hypothesize that the balance and postural control recovery requires a multimodal strategy, and we propose robotic balance training (RBT) using the Hunova platform (Movendo Technology, Italy), as it has an advantage of supporting dynamic balance in not only sagittal plane but also transverse plane (mediolateral and anterior-posterior directions), and allows for core stability and trunk control with its unique seated balance exercises. In addition, we hypothesize that by using high-definition transcranial direct current stimulation (HD-tDCS) as an adjuvant to RBT, HD-tDCS will facilitate top-down neuromuscular control of balance through corticospinal circuits, whereas the robotic platform will enable bottom-up feedback of response to platform perturbations. Overall, we anticipate that the combined intervention will improve reactive and anticipatory postural control, position sense, and proprioceptive control, gain lower-limb strength, increase ankle range of motion, and stimulate attention through game-like exercises.
Study Design: We propose a single-center, investigator-blinded, randomized, sham-controlled triple-arm parallel-group, superiority trial study. Forty-five adult individuals with chronic TBI with complaints of balance dysfunction (injury onset \> 6 months before screening) will be randomized into one of the three groups: (1) Real HD-tDCS + RBT, (2) Sham HD-tDCS + RBT, and (3) Control group receiving dose-matched standard of care rehabilitation treatment. All participants will undergo 12 sessions (3 days × 4 weeks) of intervention. A total of 3 assessment visits (before training, immediately after 4-week training, and 2-months after the last training visit) will be conducted to evaluate the functional recovery and neurophysiological changes due to intervention.
Specific Aim-1: To determine whether there is an overall treatment effect of targeted neuromodulation combined with robotic balance training on balance outcomes immediately after 4-week training function in people with TBI. The change in Berg Balance Scale score from baseline to 4-week post-training will be the primary outcome measure. The secondary outcome measures of balance recovery will be the changes in Mini BESTest, Functional Gait Assessment, and Trunk Impairment Scale scores from baseline to 4-week post-training. We hypothesize that the Real HD-tDCS + RBT will show the largest improvement in the balance outcomes.
Secondary Aim-2: To characterize the top-down and bottom-up neurophysiological mechanisms of balance control due to neuromodulation-enhanced robotic training. We will measure the neurophysiological outcomes of EEG and EMG activity, and posturography outcomes of body sway during platform perturbation task at baseline, 4-week post-training, and 2-month follow-up. Specifically, the intervention-induced changes in the cortical reactivity amplitude, muscle coactivation, and center of displacement will be compared across groups.
Secondary Aim-3: To study the association between the intervention-related changes in the balance function endpoints and graph-theoretic measures of cortical functional connectivity. We will use a multivariate statistical approach-partial least squares correlation-to identify a latent component that characterizes the correlation between the 4-week intervention-related changes in balance outcome measures and EEG corticocortical functional connectivity features measured during platform perturbation task.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RBT + Active HD-tDCS Group | Experimental | Device: Combined (Robotic balance training and high-definition transcranial direct current stimulation)Participants will engage in balance and postural control training on a robotic balance platform called Hunova (Movendo, Italy). Before balance training, the current intensity of 2 mA will be delivered to the leg motor area identified using neuronavigated transcranial magnetic stimulation, and the stimulation will be turned ON for 20 minutes. |
| RBT + Sham HD-tDCS Group | Sham comparator | Device: Combined (Robotic balance training and high-definition transcranial direct current stimulation)Participants will engage in balance and postural control training on a robotic balance platform called Hunova (Movendo, Italy). Before balance training, the current intensity of 2 mA will be delivered to the leg motor area identified using neuronavigated transcranial magnetic stimulation, and the stimulation will be turned ON transiently for 30 s, to provide a sensation of stimulation. |
| SOC Control Group | Other | Other: Standard of Care Balance TrainingThe SOC control group participants will perform conventional physical therapy exercises delivered by a trained PT. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged between 18-75 years
- Diagnosed with a non-penetrating TBI at least six months before the screening.
- Have complaints of impaired balance and poor postural control determined by a BBS score of ≤50.
- Ability to stand upright with or without support for at least 20 seconds
- Ability to walk with or without a walking aid for at least ten meters
Key exclusion criteria (9 listed)
- Currently undergoing any regular physical therapy program or research studies focusing on balance functions.
- Having a stroke or a penetrating TBI.
- Affected by the peripheral nerve injury, neuromuscular conditions, or orthopedic issues of lower limbs before TBI, or have any persistent pain or difficulty maintaining blood pressure while upright.
- Have a scalp or skin condition (e.g., psoriasis or eczema) on the scalp near the stimulation site.
- Severe visual impairment (e.g., spatial neglect) or hearing problems may affect study compliance.
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 |
|---|---|---|
| Combined (Robotic balance training and high-definition transcranial direct current stimulation)The robotic platform will train the participants to maintain dynamic balance in the sagittal and the transverse planes (mediolateral and anterior-posterior directions) and engage in core stability and trunk control with seated balance exercises. In addition, high-definition transcranial direct current stimulation (HD-tDCS) will be used as an adjuvant to robotic balance training by priming the corticospinal circuits. | Device | RBT + Active HD-tDCS Group, RBT + Sham HD-tDCS Group |
| Standard of Care Balance TrainingParticipants in this group will receive a standard-of-care balance training administered by the Physical therapist. | Other | SOC Control Group |
Primary outcome
Berg Balance Scale (BBS)
Time frame: Baseline, post 4-week training, 2-month follow-up
A widely used outcome measure of static standing balance function (Newstead et al., 2005), categorized under the 'Activity' subsection of ICF domain. BBS scores range from 0 to 56 (the higher, the better). The change in BBS scores from baseline to 4 weeks post-training will be the primary endpoint.
11 secondary outcomes
Functional Gait Assessment (FGA)
Time frame: Baseline, post 4-week training, and 2-month follow-up
Mini Balance Evaluation Systems Test (MBT)
Time frame: Baseline, post 4-week training, and 2-month follow-up
Trunk Impairment Scale (TIS)
Time frame: Baseline, post 4-week training, and 2-month follow-up
Center of Pressure (COP) Displacement
Time frame: Baseline, post 4-week training, and 2-month follow-up
TMS-evoked EEG Potentials (TEP)
Time frame: Baseline, post 4-week training, and 2-month follow-up
EEG Corticocortical Functional Connectivity
Time frame: Baseline, post 4-week training, and 2-month follow-up
EEG-to-EMG Corticomuscular Connectivity
Time frame: Baseline, post 4-week training, and 2-month follow-up.
EMG Muscle Coactivation
Time frame: Baseline, post 4-week training, and 2-month follow-up.
Quality of Life after Brain Injury (QOLIBRI)
Time frame: Baseline, post 4-week training, and 2-month follow-up.
Physical Activity Enjoyment Scale (PACES)
Time frame: Post 4-week training
Dizziness Handicap Inventory (DHI)
Time frame: Baseline, post 4-week training, and 2-month follow-up.
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 6 Aug 2025.
- Individual participant dataSharing planned: Yes. We will submit the IPD available in the tabular data to the Open Data Commons for Traumatic Brain Injury (ODC-TBI) after removing any personal or private identifiers. The neurophysiological data (such as the EEG, TMS, and EMG) will be shared on OpenNeuro.org (or a similar platform) in a BIDS-standardized format.
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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.
Kathleen Goworek, B.S. contact
Vikram Shenoy Handiru, Ph.D. 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 Combined (Robotic balance training and high-definition transcranial direct current stimulation) in people with Traumatic Brain Injury and TBI, 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 7 inclusion and 9 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 6 Aug 2025. 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. Some participants in this study may receive a placebo. 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 Vikram Shenoy Handiru, Ph.D. (9733243578, vshenoy@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (BBS) (time frame: Baseline, post 4-week training, 2-month follow-up). 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 6 Aug 2025.