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Clinical Trials/NCT05268484
NCT05268484
Recruiting
N/A

Improving Anticipatory and Compensatory Postural Responses to Avoid Falls After TBI

Kessler Foundation1 site in 1 country45 target enrollmentJune 26, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
Kessler Foundation
Enrollment
45
Locations
1
Primary Endpoint
Berg Balance Assessment
Status
Recruiting
Last Updated
2 years ago

Overview

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..

Registry
clinicaltrials.gov
Start Date
June 26, 2019
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kessler Foundation
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Berg Balance Assessment

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Timed up and GO (TUG)(4 weeks)
  • Limits of Stability(4 weeks)
  • Center of Mass (CoM)(4 weeks)
  • Mobility Course(4 weeks)
  • Center of Pressure (CoP)(4 weeks)
  • Joint kinematics(4 weeks)
  • Silver Index(4 weeks)

Study Sites (1)

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