Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06184295

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

Led by Kessler Foundation · Updated on 2024-12-05

30

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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. The TBI intervention Group will participate in 10 robotic balance training sessions. Data will collected pre and post-training. TBI- non-intervention group will not receive any training. They will participate in two data collection sessions which are about 5 weeks apart. The participants without disability group will not receive any training. They will participate in one data collection session.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Be between the ages of 18 and 65.
  • Diagnosed with a traumatic brain injury (TBI) by a physician.
  • At least 6 months and not more than 5 years post injury.
  • Medically stable for 3 months prior to the most recent TBI.
  • No planned drastic medication changes for at least 4 weeks.
  • Able to stand unsupported for 5 minutes.
  • Willing and able to give informed consent.
  • Able and willing to follow study procedures and follow-up requirements.
  • For participants without disability: no orthopedic, cognitive, or neuromuscular disease.
Not Eligible

You will not qualify if you...

  • Weight above 300 lbs.
  • Severe cardiac disease such as heart attack or moderate/severe congestive heart failure.
  • Pre-existing conditions causing major disruption in lower limb alignment or function during standing.
  • Medical conditions affecting bones, muscles, or nerves that interfere with balance or movement.
  • History of balance problems before TBI.
  • Fluctuating blood pressure.
  • Use of medications affecting balance, strength, or muscle coordination (e.g., Botox).
  • Currently enrolled in another research study likely to affect participation.
  • Seizure disorder.
  • For participants without disability: history of lower limb injury in past 90 days or difficulty following commands.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Kessler Foundation

West Orange, New Jersey, United States, 07052

Actively Recruiting

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Research Team

K

Kiran Karunakaran, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Robotic Balance Training to Improve Postural Control and Balance Post-Traumatic Brain Injury | DecenTrialz