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Robotic Balance Training for Traumatic Brain Injury

This study is testing if robotic balance training can help improve balance and prevent falls in people who have had a traumatic brain injury (TBI). Participants will be between 18 and 65 years old, diagnosed with a TBI between 6 months and 5 years ago, and medically stable. The study involves three groups: one group will receive 10 sessions of robotic balance training using the Hunova device, another TBI group will not receive training, and a third group without disability will also not receive training. Researchers will measure balance and walking ability after about 5 weeks to see if the training is helpful. The current status of the study is unclear, and it plans to enroll 30 participants.

Study design
This interventional study involves three groups: one TBI group receiving robotic training, one TBI group not receiving training, and one group without disability not receiving training. It plans to enroll 30 participants.
What's involved
If you are in the TBI intervention group, you will participate in 10 robotic balance training sessions, each lasting up to 1.5 hours. Data will be collected before and after training. If you are in the TBI non-intervention group, you will participate in two data collection sessions about 5 weeks apart.
Compensation
Not stated in the trial record.
Follow-up
Balance and walking ability will be measured at 5 weeks after the start of the study for the TBI groups.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06184295

Robotic Balance Training to Improve Postural Control and Balance Post-Traumatic Brain Injury

Recruiting
NAAges 18–65InterventionalTreatment
Kessler Foundation
~30 participants
Updated 2024-12-05 on ClinicalTrials.gov
What's tested:TBI - Intervention Group

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Berg Balance Assessment
Measured over 5 weeks
+9 more outcomes measured

Conditions

Traumatic Brain Injury

Explore related trials

Traumatic Encephalopathy

Where it's being run

1 sites across 1 states
New Jersey1

Study leadership

  • Kiran Karunakaran · PRINCIPAL_INVESTIGATOR · Kessler Foundation

Who to contact

Kiran Karunakaran, Ph.D.
[email protected]
973-324-3590
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.

Exclusion

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.
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.
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.

What this trial measures

  • Berg Balance Assessment5 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 Index5 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 Go5 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 test5 weeks

    Participants will be asked to walk about 12 meters. The time taken to walk 10 meters will be recorded.

  • Fall Efficacy Scale -International5 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 Scale5 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 characteristics5 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.

  • Electromyography5 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 activity5 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.

  • Balance5 weeks

    Quantitative measures of static and dynamic balance will be assessed using the Hunova balance platform.