Traumatic Brain InjuryNCT06184295
Robotic Balance Training to Improve Postural Control and Balance Post-Traumatic Brain Injury
A study testing TBI - Intervention Group in people with Traumatic Brain Injury, run by Kessler Foundation at 1 site in United States.
Trial summary
The purpose of this study is to assess a balance training program to see if it can be helpful to improve balance and avoid falls in people who have had traumatic brain injuries (TBIs). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- TBI - Intervention Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 31 Dec 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be between the ages of 18 and 65.
- Have been diagnosed with a TBI by a physician and be at least 6 months post injury and not more than 5 years post injury.
- Have been medically stable for 3 months prior to the most recent TBI.
- Not plan to make any drastic changes to medications (as determined by study staff) for at least 4 weeks.
- Be able to stand unsupported for 5 minutes.
- Be willing and able to give informed consent.
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- Be able and willing to comply with study procedures, verbal instructions, and follow-up requirements.
- Be between the ages of 18 and 65.
- Not plan to make any drastic changes to medications for at least 4 weeks.
- Not have an orthopedic, cognitive or neuromuscular disease.
- Be able to stand unsupported for 5 minutes.
- Be willing and able to give informed consent.
- Be able and willing to comply with study procedures, including follow-up requirements.
Who cannot join
- Weight above 300 lbs.
- Have severe cardiac disease such as heart attack or moderate or severe congestive heart failure.
- Have a pre-existing condition resulting in significant disruption in alignment or function of the lower limb during standing.
- Have additional medical conditions that affect the bones, muscles or nerves that would interfere with the balance.
- Have any previously diagnosed history of balance problems prior to TBI.
- Have fluctuating blood pressure.
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- Be on any medication that may affect balance, strength, or muscle coordination (e.g. Botox).
- Be currently enrolled in another research study that is likely to affect participation in this research study.
- Have seizure disorder.
- Participants without a disability:
- Weight above 300 lbs.
- Have a history of injury to my lower limbs in the past 90 days.
- Have severe cardiac disease such as heart attack or moderate or severe congestive heart failure.
- Have a pre-existing condition resulting in significant disruption in alignment or function of the lower limb during standing.
- Have any additional medical conditions that affect my bones, muscles, or nerves that would interfere with the movement or the ability to feel touch or pain.
- Have difficulty following or responding to commands that would limit the study participation.
- Be currently enrolled in another research study that is likely to affect participation in this research study.
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
Kiran Karunakaran, PhD, 973-324-3590
Kiran Karunakaran, PhD
About this study
Official title: Robotic Balance Training to Improve Postural Control and Balance Post-Traumatic Brain
The purpose of this study is to assess a balance training program to see if it can be helpful to improve balance and avoid falls in people who have had traumatic brain injuries (TBIs).
The study will involve three groups of research subjects: 1) TBI-intervention group, 2) TBI- non-intervention group and 3) the participants without disability group.
Read more
The TBI intervention Group will participate in 10 robotic balance training sessions. Data will collected pre and post-training.
TBI- non-intervention group will not receive any training. They will participate in two data collection sessions which are about 5 weeks apart.
The participants without disability group will not receive any training. They will participate in one data collection session.
- Conditions
- Traumatic Brain Injury
- Being tested
- TBI - Intervention Group
- 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.
TBI - Intervention GroupDevice
The participants will receive 10 customized robotic balance training sessions to improve balance using the Hunova robotic device. Each session will last for up to 1.5 hours. The training may include standing or sitting on the robotic balance platform and performing the following tasks: maintaining balance when the platform becomes unstable or moving in various directions, or in an inclination; these tasks may be performed as instructed with eyes open or eyes closed condition; move in different directions to reach targets with my hands; stand on one leg or heel to toe and maintain balance; perform head or torso rotation while standing or sitting. All training will be performed with an overhead harness and a spotter will be present at all times.
| Study group | Role | What they receive |
|---|---|---|
| TBI - Intervention Group | Experimental | The participants will receive 10 customized robotic balance training sessions to improve balance using the Hunova robotic device. Each session will last for up to 1.5 hours. The training may include standing or sitting on the robotic balance platform and performing the following tasks: maintaining balance when the platform becomes unstable or moving in various directions, or in an inclination; these tasks may be performed as instructed with eyes open or eyes closed condition; move in different directions to reach targets with my hands; stand on one leg or heel to toe and maintain balance; perform head or torso rotation while standing or sitting. All training will be performed with an overhead harness and a spotter will be present at all times. Receives: Device: TBI - Intervention Group |
| TBI - Non Intervention Group | No intervention | Participants will receive no intervention |
| Participants without disability group | No intervention | Participants will receive no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Assessment
A task performance test consisting of 14 items of increasing difficulty graded on a five-point ordinal scale of 0 to 4 (0 = subject is unable to perform task; 4 = subject is independent in performance of task) giving the best possible score of 56 for healthy balance.
Measured: 5 weeks
Dynamic Gait Index
Dynamic Gait Index (DGI) is a measurement tool commonly used to assess dynamic balance, gait and risk for falls. 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: 5 weeks
Timed Up and Go
It 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 stopwatch.
Measured: 5 weeks
10 Meter walk test
Participants will be asked to walk about 12 meters. The time taken to walk 10 meters will be recorded.
Measured: 5 weeks
Fall Efficacy Scale -International
This questionnaire is a widely accepted tool for the assessment of fear of falling and has excellent reliability and validity. It is a self-reported questionnaire that provides information on the level of concern about falls for a range of daily living activities. The original questionnaire contains 16 items and is scored on a four-point scale (1 = not very concerned to 4 = very concerned). Therefore the best possible value is 16 and the worst is 64.
Measured: 5 weeks
Community Balance and Mobility Scale
Used to detect 'high level' balance and mobility deficits based on tasks commonly encountered in community environments. Composed of 13 challenging tasks (scaled from 0 = complete inability to perform task to 5 = most successful completion of item available).
Measured: 5 weeks
Temporal- spatial characteristics
Participants will be asked to walk about 10 meters on a pressure mat. Pressure mat (ZenoMat, Protokinetics LLC) will be used to collect gait cycle times and step length, in order to determine inter- and intra-limb temporal and spatial characteristics.
Measured: 5 weeks
Electromyography
surface Electromyography (EMG) wireless sensors will be used to measure the activation of tibialis anterior, soleus, vastus lateralis, rectus femoris, bicep femoris, and gastrocnemius.
Measured: 5 weeks
Cortical activity
Cortical activity will be measured using NIRSport 2 (NIRX Medical Technologies, LLC ), an Functional Near Infrared Spectroscopy (fNIRS) system. NIRSport 2 is a portable, non-invasive optical imaging technique to measure the cerebral hemodynamic response.
Measured: 5 weeks
Balance
Quantitative measures of static and dynamic balance will be assessed using the Hunova balance platform.
Measured: 5 weeks
Secondary outcomes (1)
community ambulation
Sensors will be provided to be worn in wrist, leg and waist to collect gait cycle times and step length during community ambulation of the participants between baseline and follow-up. The participants will also wear the sensor during testing walking and balancing tasks at baseline and follow-up.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start1 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kiran Karunakaran, Kessler Foundation
- Investigators
- Kiran Karunakaran, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184295
- Sponsor's protocol ID
- R-1229-23
- Status last verified
- Dec 2024
- First submitted
- 14 Dec 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Balance Training to Improve Postural Control and Balance Post-Traumatic Brain
- ClinicalTrials.gov ID
- NCT06184295
- Acronym / sponsor ID
- R-1229-23
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Dec 2023 (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.
The purpose of this study is to assess a balance training program to see if it can be helpful to improve balance and avoid falls in people who have had traumatic brain injuries (TBIs).
The study will involve three groups of research subjects: 1) TBI-intervention group, 2) TBI- non-intervention group and 3) the participants without disability group.
The TBI intervention Group will participate in 10 robotic balance training sessions. Data will collected pre and post-training.
TBI- non-intervention group will not receive any training. They will participate in two data collection sessions which are about 5 weeks apart.
The participants without disability group will not receive any training. They will participate in one data collection session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TBI - Intervention Group | Experimental | Device: TBI - Intervention GroupThe participants will receive 10 customized robotic balance training sessions to improve balance using the Hunova robotic device. Each session will last for up to 1.5 hours. The training may include standing or sitting on the robotic balance platform and performing the following tasks: maintaining balance when the platform becomes unstable or moving in various directions, or in an inclination; these tasks may be performed as instructed with eyes open or eyes closed condition; move in different directions to reach targets with my hands; stand on one leg or heel to toe and maintain balance; perform head or torso rotation while standing or sitting. All training will be performed with an overhead harness and a spotter will be present at all times. |
| TBI - Non Intervention Group | No intervention | –Participants will receive no intervention |
| Participants without disability group | No intervention | –Participants will receive no intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Be between the ages of 18 and 65.
- Have been diagnosed with a TBI by a physician and be at least 6 months post injury and not more than 5 years post injury.
- Have been medically stable for 3 months prior to the most recent TBI.
- Not plan to make any drastic changes to medications (as determined by study staff) for at least 4 weeks.
- Be able to stand unsupported for 5 minutes.
Key exclusion criteria (17 listed)
- Weight above 300 lbs.
- Have severe cardiac disease such as heart attack or moderate or severe congestive heart failure.
- Have a pre-existing condition resulting in significant disruption in alignment or function of the lower limb during standing.
- Have additional medical conditions that affect the bones, muscles or nerves that would interfere with the balance.
- Have any previously diagnosed history of balance problems prior to TBI.
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 |
|---|---|---|
| TBI - Intervention GroupThe participants will receive 10 customized robotic balance training sessions to improve balance using the Hunova robotic device. Each session will last for up to 1.5 hours. The training may include standing or sitting on the robotic balance platform and performing the following tasks: maintaining balance when the platform becomes unstable or moving in various directions, or in an inclination; these tasks may be performed as instructed with eyes open or eyes closed condition; move in different directions to reach targets with my hands; stand on one leg or heel to toe and maintain balance; perform head or torso rotation while standing or sitting. All training will be performed with an overhead harness and a spotter will be present at all times. | Device | TBI - Intervention Group |
Primary outcome
Berg Balance Assessment
Time frame: 5 weeks
A task performance test consisting of 14 items of increasing difficulty graded on a five-point ordinal scale of 0 to 4 (0 = subject is unable to perform task; 4 = subject is independent in performance of task) giving the best possible score of 56 for healthy balance.
Dynamic Gait Index
Time frame: 5 weeks
Dynamic Gait Index (DGI) is a measurement tool commonly used to assess dynamic balance, gait and risk for falls. 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.
Timed Up and Go
Time frame: 5 weeks
It 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 stopwatch.
10 Meter walk test
Time frame: 5 weeks
Participants will be asked to walk about 12 meters. The time taken to walk 10 meters will be recorded.
Fall Efficacy Scale -International
Time frame: 5 weeks
This questionnaire is a widely accepted tool for the assessment of fear of falling and has excellent reliability and validity. It is a self-reported questionnaire that provides information on the level of concern about falls for a range of daily living activities. The original questionnaire contains 16 items and is scored on a four-point scale (1 = not very concerned to 4 = very concerned). Therefore the best possible value is 16 and the worst is 64.
Community Balance and Mobility Scale
Time frame: 5 weeks
Used to detect 'high level' balance and mobility deficits based on tasks commonly encountered in community environments. Composed of 13 challenging tasks (scaled from 0 = complete inability to perform task to 5 = most successful completion of item available).
Temporal- spatial characteristics
Time frame: 5 weeks
Participants will be asked to walk about 10 meters on a pressure mat. Pressure mat (ZenoMat, Protokinetics LLC) will be used to collect gait cycle times and step length, in order to determine inter- and intra-limb temporal and spatial characteristics.
Electromyography
Time frame: 5 weeks
surface Electromyography (EMG) wireless sensors will be used to measure the activation of tibialis anterior, soleus, vastus lateralis, rectus femoris, bicep femoris, and gastrocnemius.
Cortical activity
Time frame: 5 weeks
Cortical activity will be measured using NIRSport 2 (NIRX Medical Technologies, LLC ), an Functional Near Infrared Spectroscopy (fNIRS) system. NIRSport 2 is a portable, non-invasive optical imaging technique to measure the cerebral hemodynamic response.
Balance
Time frame: 5 weeks
Quantitative measures of static and dynamic balance will be assessed using the Hunova balance platform.
1 secondary outcome
community ambulation
Time frame: 5 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 5 Dec 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 Karunakaran 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 TBI - Intervention Group 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 13 inclusion and 17 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 5 Dec 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 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?
Berg Balance Assessment (time frame: 5 weeks). The study lists 10 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 5 Dec 2024.