Clinical trial NCT05268484: Improving Anticipatory and Compensatory Postural Responses to Avoid Falls After TBI
Official title: Improving Anticipatory and Compensatory Postural Responses to Avoid Falls After TBI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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..


Eligibility criteria: 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.

Primary outcomes:
measure: Berg Balance Assessment
timeFrame: 4 weeks
measure: Fall Efficacy Scale -International
timeFrame: 4 weeks
measure: Anticipatory Postural Adjustment- Compensatory Postural Adjustment measures
timeFrame: 4 weeks
Secondary outcomes:
measure: Timed up and GO (TUG)
timeFrame: 4 weeks
measure: Center of Mass (CoM)
timeFrame: 4 weeks
measure: Center of Pressure (CoP)
timeFrame: 4 weeks
measure: Limits of Stability
timeFrame: 4 weeks
measure: Joint kinematics
timeFrame: 4 weeks
measure: Silver Index
timeFrame: 4 weeks
measure: Mobility Course
timeFrame: 4 weeks
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References: