Balance training to prevent falls in people with traumatic brain injury

Improving Anticipatory and Compensatory Postural Responses to Avoid Falls After TBI

This study is testing a balance training program to see if it can help people with traumatic brain injuries avoid falls.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Kessler Foundation (Academic / other)
• Locations: 1 site (West Orange, New Jersey)
• Trial ID: NCT05268484 on ClinicalTrials.gov

What this trial studies

This study evaluates a balance training program aimed at reducing fall risk in individuals who have experienced traumatic brain injuries (TBIs). Participants will be divided into three groups: a TBI intervention group receiving 16 training sessions on anticipatory and compensatory postural adjustments using the Neurocom Balance Platform, a TBI control group, and a healthy control group. The training sessions will utilize visual cues to help participants anticipate and respond to balance disturbances effectively. The goal is to assess the effectiveness of this training in improving balance and reducing falls among TBI patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 70 who are at least 6 months post-TBI and medically stable.

Not a fit: Patients with recent injuries or those unable to stand unsupported for 5 minutes may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly reduce the risk of falls in individuals recovering from traumatic brain injuries.

How similar studies have performed: Other studies have shown promise in using balance training to improve outcomes for individuals with similar conditions, suggesting this approach may be effective.

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.

Where this trial is running

West Orange, New Jersey

• Kessler Foundation — West Orange, New Jersey, United States (Recruiting)

Study contacts

• Study coordinator: Kiran K Karunakaran, PhD

Conditions Traumatic Brain Injury