Recruiting NA Traumatic Brain Injury

New treatment option for Traumatic Brain Injury

Official title Robotic Balance Training to Improve Postural Control and Balance Post-Traumatic Brain Injury

ClinicalTrials.gov ID: NCT06184295

What this study is testing

What it's testing: 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 involve three groups of research subjects: 1) TBI-intervention group, 2) TBI- non-intervention group and 3) the participants without disability group.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 65. Healthy volunteers may be eligible.

You may be able to join if

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.

You likely can't join if

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.

See the full eligibility criteria

Who can join

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.

What rules you out

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.

The study team makes the final eligibility decision.

Where it's taking place

West Orange, New Jersey, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include West Orange, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.