Status:
RECRUITING
Robotic Balance Training to Improve Postural Control and Balance Post-Traumatic Brain Injury
Lead Sponsor:
Kessler Foundation
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-65 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 improve balance and avoid falls in people who have had traumatic brain injuries (TBIs). The study will...
Eligibility Criteria
Inclusion
- Participants with TBI:
- Be between the ages of 18 and 65.
- Have been diagnosed with a TBI by a physician and be at least 6 months post injury and not more than 5 years post injury.
- Have been medically stable for 3 months prior to the 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.
Exclusion
- Weight above 300 lbs.
- 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 additional medical conditions that affect the bones, muscles or nerves that would interfere with the balance.
- Have any previously diagnosed history of balance problems prior to TBI.
- Have fluctuating blood pressure.
- Be on any medication that may affect 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.
- Have seizure disorder.
- Participants without a disability:
- Inclusion Criteria:
- Be between the ages of 18 and 65.
- Not plan to make any drastic changes to medications for at least 4 weeks.
- Not have an orthopedic, cognitive or neuromuscular disease.
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06184295
Start Date
January 1 2024
End Date
December 31 2024
Last Update
December 5 2024
Active Locations (1)
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1
Kessler Foundation
West Orange, New Jersey, United States, 07052