An interventional study of Perturbation-based Training with visual cues using Neurocom in Traumatic Brain Injury, sponsored by Kessler Foundation. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-19.
Sponsored by Kessler Foundation · Not applicable, Interventional, and Treatment
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..
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's planned enrollment of 45 is close to the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
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INCLUSION CRITERIA FOR TRAUMATIC BRAIN INJURY:
In order to be eligible to participate in this study, I must:
INCLUSION CRITERIA FOR HEALTHY INDIVIDUALS:
In order to be eligible to participate in this study, I must:
EXCLUSIONS FOR TRAUMATIC BRAIN INJURY:
I must NOT:
EXCLUSIONS FOR HEALTHY INDIVIDUALS:
I must NOT:
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
No intervention is provided
No intervention is provided
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks
Timed up and GO (TUG)
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.
Time frame: 4 weeks
Center of Mass (CoM)
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.
Time frame: 4 weeks
Center of Pressure (CoP)
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.
Time frame: 4 weeks
Limits of Stability
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.
Time frame: 4 weeks
Joint kinematics
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.
Time frame: 4 weeks
Silver Index
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.
Time frame: 4 weeks
Mobility Course
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.
Time frame: 4 weeks
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