Recruiting

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

Sponsor:

Kessler Foundation

Code:

NCT06184295

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

TBI - Intervention Group

Study Details

Brief 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).

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.

Conditions

Traumatic Brain Injury

Study ID

NCT06184295

Start date

Jan 1, 2024

Status verified date

Dec, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Participants with TBI:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Participants without a disability:

Inclusion Criteria:

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 Criteria:

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TBI - Intervention Group

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.

no intervention: TBI - Non Intervention Group

Participants will receive no intervention

no intervention: Participants without disability group

Participants will receive no intervention

Interventions

TBI - Intervention Group

Primary outcome measure

Berg Balance Assessment [ Time Frame: 5 weeks ]
Dynamic Gait Index [ Time Frame: 5 weeks ]
Timed Up and Go [ Time Frame: 5 weeks ]
10 Meter walk test [ Time Frame: 5 weeks ]
Fall Efficacy Scale -International [ Time Frame: 5 weeks ]
Community Balance and Mobility Scale [ Time Frame: 5 weeks ]
Temporal- spatial characteristics [ Time Frame: 5 weeks ]
Electromyography [ Time Frame: 5 weeks ]
Cortical activity [ Time Frame: 5 weeks ]
Balance [ Time Frame: 5 weeks ]

Central Contacts and Locations

Central contacts

Kiran Karunakaran, Ph.D.

973-324-3590 kkarunakaran@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Kiran Karunakaran, PhD

973-324-3590

Principal Investigator:

Kiran Karunakaran, PhD

More Information

Sponsor

Kessler Foundation

Last update posted

Dec 5, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2024-12-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.