Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
NCT ID:
NCT06184295
Eligibility Criteria:
Participants with TBI:
Inclusion Criteria:
* 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 Criteria:
* 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.
Exclusion Criteria:
* Weight above 300 lbs.
* 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 the movement or the ability to feel touch or pain.
* Have difficulty following or responding to commands that would limit the study participation.
* Be currently enrolled in another research study that is likely to affect participation in this research study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06184295
Study Brief:
Protocol Section:
NCT06184295