Improving Anticipatory and Compensatory Postural Responses to Avoid Falls After TBI

Not Applicable

Recruiting

• Conditions: Traumatic Brain Injury

• Registration Number: NCT05268484
• Lead Sponsor: Kessler Foundation

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..

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-26
• Study First Submitted: 2022-02-25
• Study First Submitted QC: 2022-02-25
• Study First Posted: 2022-03-07
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-19
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Berg Balance Assessment	4 weeks	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.
Fall Efficacy Scale -International	4 weeks	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.
Anticipatory Postural Adjustment- Compensatory Postural Adjustment measures	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Timed up and GO (TUG)	4 weeks	TUG is a clinical test of functional gait abilities and dynamic balance. The participants will be asked to walk a distance of 3 meters from a seated position, turn around, walk back to the chair and sit back in the chair.
Limits of Stability	4 weeks	The limits of stability will be collected using Neurocom. It quantifies the maximum distance the patient can intentionally displace their center of gravity in the four cardinal directions and the four diagonal directions, and maintain stability at those positions.
Center of Mass (CoM)	4 weeks	Center of Mass will be collected using Neurocom during small perturbations during quiet standing. All participants will wear a safety harness and a spotter will be present at all times. Root-mean-squared values of CoM displacements will be used for quantifying postural responses.
Mobility Course	4 weeks	Participants will wear Actigraph activity monitor on their wrist, ankle and waist. Their activities (walking in a room about 20 ft long, sitting, standing and walking up and down stairs) will be measured.
Center of Pressure (CoP)	4 weeks	Center of Pressure will be collected using Neurocom during small perturbations during quiet standing. All participants will wear a safety harness and a spotter will be present at all times. Root-mean-squared values of CoP displacements will be used for quantifying postural responses.
Joint kinematics	4 weeks	Lower extremity joint kinematics (ankle, knee and hip angles) will be computed using Motion Analysis system in the sagittal plane to quantify postural deviations during small perturbations during queit standing using Neurocom. All participants will wear a safety harness and a spotter will be present at all times.
Silver Index	4 weeks	Silver index using Movendo Technology platform (Movendo Technology Srl,, Italy) is an objective test that enables to predict falls by assessing static and dynamic balance. Participants will be asked to stand on the Hunova platform. Silver index includes the following tasks: stand with eyes open or eyes closed, stand when the surface is perturbed, move torso on all four sides, perform sit to stand.

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 West Orange, New Jersey, United States