Improving Anticipatory and Compensatory Postural Responses to Avoid Falls After TBI

NCT05268484 | Unknown FDA Device

• 1 other identifier: R-1072-19
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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.

  4 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.

  4 weeks

• Anticipatory Postural Adjustment- Compensatory Postural Adjustment measures

  Electromyography 200 ms before the onset of perturbation and 200 ms after the onset of perturbation will be computed for Anticipatory Postural Adjustment- Compensatory Postural Adjustment measures.

  4 weeks

Secondary Outcomes (7)

• Timed up and GO (TUG)

  4 weeks

• Center of Mass (CoM)

  4 weeks

• Center of Pressure (CoP)

  4 weeks

• Limits of Stability

  4 weeks

• Joint kinematics

  4 weeks

Study Arms (3)

TBI Intervention Group

EXPERIMENTAL

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.

Device: Perturbation-based Training with visual cues using Neurocom

TBI Control Group

NO INTERVENTION

No intervention is provided

Healthy Control

NO INTERVENTION

No intervention is provided

Interventions

Perturbation-based Training with visual cues using Neurocom 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.

Also known as: Perturbation-based Training with visual cues (PBTvc)

TBI Intervention Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Kiran K Karunakaran, PhD

CONTACT

973-324-3590; karunakaran@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 7, 2022
• Study Start: June 26, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

US (1)