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NCT05268484

Improving Anticipatory and Compensatory Postural Responses to Avoid Falls After TBI

Status unknown NA Last updated 19 December 2023
What this trial tests

NA trial testing Perturbation-based Training with visual cues using Neurocom in Traumatic Brain Injury in 45 participants. Status unknown.

Timeline
26 June 2019
Primary endpoint
31 December 2024
31 December 2024

Quick facts

Lead sponsorKessler Foundation
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment45
Start date26 June 2019
Primary completion31 December 2024
Estimated completion31 December 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Kessler Foundation

Who can join

Adults 18 to 70, any sex, with Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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..

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Traumatic Brain Injury

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing