Back to resultsImproving Anticipatory and Compensatory Postural Responses to Avoid Falls After TBI
Primary Purpose
Traumatic Brain Injury
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Perturbation-based Training with visual cues using Neurocom
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury
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.
Sites / Locations
- Kessler FoundationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
TBI Intervention Group
TBI Control Group
Healthy Control
Arm Description
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.
No intervention is provided
No intervention is provided
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05268484
First Posted
February 25, 2022
Last Updated
February 25, 2022
Sponsor
Kessler Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05268484
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kessler Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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..
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TBI Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
TBI Control Group
Arm Type
No Intervention
Arm Description
No intervention is provided
Arm Title
Healthy Control
Arm Type
No Intervention
Arm Description
No intervention is provided
Intervention Type
Device
Intervention Name(s)
Perturbation-based Training with visual cues using Neurocom
Other Intervention Name(s)
Perturbation-based Training with visual cues (PBTvc)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Berg Balance Assessment
Description
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
Title
Fall Efficacy Scale -International
Description
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
Title
Anticipatory Postural Adjustment- Compensatory Postural Adjustment measures
Description
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
Secondary Outcome Measure Information:
Title
Timed up and GO (TUG)
Description
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
Title
Center of Mass (CoM)
Description
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
Title
Center of Pressure (CoP)
Description
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
Title
Limits of Stability
Description
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
Title
Joint kinematics
Description
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
Title
Silver Index
Description
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
Title
Mobility Course
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kiran K Karunakaran, PhD
Phone
973-324-3590
Email
karunakaran@kesslerfoundation.org
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oluwaseun Ibironke
Phone
973-324-3513
12. IPD Sharing Statement
Learn more about this trial
Improving Anticipatory and Compensatory Postural Responses to Avoid Falls After TBI
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