Improving Anticipatory and Compensatory Postural Responses to Avoid Falls After TBI

NCT ID: NCT05268484

Last Updated: 2023-12-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-26
• Study Completion Date: 2024-12-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Perturbation-based Training with visual cues using Neurocom

Intervention Type: DEVICE

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.

TBI Control Group

No intervention is provided

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healthy Control

No intervention is provided

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Perturbation-based Training with visual cues using Neurocom

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.

Intervention Type: DEVICE

Other Intervention Names

Perturbation-based Training with visual cues (PBTvc)

Eligibility Criteria

Inclusion Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kessler Foundation

West Orange, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kiran K Karunakaran, PhD

Role: CONTACT

Phone: 973-324-3590

Email: karunakaran@kesslerfoundation.org

Facility Contacts

Oluwaseun Ibironke

Role: primary

Other Identifiers

R-1072-19

Identifier Type: -

Identifier Source: org_study_id