Recruiting

Observational StudyImproving Anticipatory and Compensatory Postural Responses to Avoid Falls After TBI

Sponsor:

Kessler Foundation

Code:

NCT05268484

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Perturbation-based Training with visual cues using Neurocom

Study Details

Brief summary:

The purpose of this study is to assess a balance training program to see if it can be helpful to avoid falls in people who have had traumatic brain injuries (TBIs).

The study will include 3 groups: TBI Intervention group , TBI Control Group, and healthy control group.

TBI Intervention group - These individuals will participate in 16 anticipatory postural adjustments (APA) and compensatory postural adjustments (CPA) training sessions using the Neurocom Balance Platform. Each session will last for 1 hour. During the APA portion, participants will be provided with a visual cue on the front screen in the form of a countdown timer showing the remaining seconds to the onset of the upcoming perturbation. This information will allow an opportunity for the participant to adjust their posture to handle the upcoming perturbation in the best possible way and also train them to anticipate upcoming disturbances and execute corrective motor outputs. In CPA, after a 5 second pause, the platform will oscillate at 1 Hz, with a constant amplitude, in the anterior-posterior direction for 50 seconds, followed by an additional 5 second quiet period. The participant will wear a safety harness at all times and a spotter will be present at all times.

TBI Control Group- They do not receive any intervention. healthy control group- They do not receive any intervention.

All three groups will participate in two data collection sessions: Baseline and follow-up.

At baseline and follow-up, we will collect functional, clinical, biomechanical, and physiological metrics.

During training and data collection, a spotter will be present at all times to prevent falls and participants will be allowed as much rest as needed by them..

Conditions

Traumatic Brain Injury

Study ID

NCT05268484

Start date

Jun 26, 2019

Status verified date

Dec, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

INCLUSION CRITERIA FOR TRAUMATIC BRAIN INJURY:

In order to be eligible to participate in this study, I must:

Be between the ages of 18 and 70.
Have been diagnosed with a TBI by a physician and be at least 6 months post injury
Have been medically stable for 3 months prior to my 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.

INCLUSION CRITERIA FOR HEALTHY INDIVIDUALS:

In order to be eligible to participate in this study, I must:

Be between the ages of 18 and 70.
Not plan to make any drastic changes to medications for at least 4 weeks.
Not have a history of injury or disease within the last 90 days.
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.

EXCLUSIONS FOR TRAUMATIC BRAIN INJURY:

I must NOT:

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 orthopedic, neuromuscular, or neurological conditions that would interfere with my balance.
Have had a penetrating TBI (a penetrating TBI is when an item or object goes through the skull to damage the brain).
Have any previously diagnosed history of balance problems prior to TBI.
Be able to stand without the ankle foot orthosis (AFO).
Have fluctuating blood pressure.
Be on any medication that may affect my 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.

EXCLUSIONS FOR HEALTHY INDIVIDUALS:

I must NOT:

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 my movement or my ability to feel touch or pain.
Have difficulty following or responding to commands that would limit my study participation.
Be currently enrolled in another research study that is likely to affect participation in this research study.

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TBI Intervention Group

Participants will participate in 16 anticipatory postural adjustments (APA) and compensatory postural adjustments (CPA) training sessions using the Neurocom Balance Platform. Each session will last for 1 hour. During the APA portion, a visual cue on the front screen in the form of a countdown timer showing the remaining seconds to the onset of the upcoming perturbation. This information will allow an opportunity for the participant to adjust their posture to handle the upcoming perturbation in the best possible way and also train them to anticipate upcoming disturbances and execute corrective motor outputs. This will ensure the generation of APA in a consistent and repetitive manner. In CPA, after a 5 second pause, the platform will oscillate at 1 Hz, with a constant amplitude, in the anterior-posterior direction for 50 seconds, followed by an additional 5 second quiet period. The participant will wear a safety harness at all times and a spotter will be present at all times.

no intervention: TBI Control Group

No intervention is provided

no intervention: Healthy Control

No intervention is provided

Interventions

Perturbation-based Training with visual cues using Neurocom

Primary outcome measure

Berg Balance Assessment [ Time Frame: 4 weeks ]
Fall Efficacy Scale -International [ Time Frame: 4 weeks ]
Anticipatory Postural Adjustment- Compensatory Postural Adjustment measures [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Kiran K Karunakaran, PhD

973-324-3590 karunakaran@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Oluwaseun Ibironke

973-324-3513

More Information

Sponsor

Kessler Foundation

Last update posted

Dec 19, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2023-12-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.