Robotic balance training for improving postural control after brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study assesses the effectiveness of a robotic balance training program aimed at improving balance and reducing fall risk in individuals who have experienced traumatic brain injuries (TBIs). Participants will be divided into three groups: one receiving the robotic training, one not receiving any intervention, and a control group without disabilities. The intervention group will undergo 10 training sessions, while the other groups will participate in data collection sessions to evaluate balance improvements. Data will be collected before and after the training to measure outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Kessler Foundation
  West Orange, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Kiran Karunakaran — Kessler Foundation
• Study coordinator: Kiran Karunakaran, Ph.D.
• Email: kkarunakaran@kesslerfoundation.org
• Phone: 973-324-3590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.