Status:
UNKNOWN
Improving Anticipatory and Compensatory Postural Responses to Avoid Falls After TBI
Lead Sponsor:
Kessler Foundation
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-70 years
Phase:
NA
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: T...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05268484
Start Date
June 26 2019
End Date
December 31 2024
Last Update
December 19 2023
Active Locations (1)
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1
Kessler Foundation
West Orange, New Jersey, United States, 07052