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

Last updated: December 3, 2024
Sponsor: Kessler Foundation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Traumatic Brain Injury

Neurologic Disorders

Memory Loss

Treatment

TBI - Intervention Group

Clinical Study ID

NCT06184295
R-1229-23
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 injuryand 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, andfollow-up requirements.

Exclusion

Exclusion Criteria:

  • Weight above 300 lbs.

  • Have severe cardiac disease such as heart attack or moderate or severe congestiveheart failure.

  • Have a pre-existing condition resulting in significant disruption in alignment orfunction of the lower limb during standing.

  • Have additional medical conditions that affect the bones, muscles or nerves thatwould 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 affectparticipation 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-uprequirements.

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 congestiveheart failure.

  • Have a pre-existing condition resulting in significant disruption in alignment orfunction of the lower limb during standing.

  • Have any additional medical conditions that affect my bones, muscles, or nerves thatwould interfere with the movement or the ability to feel touch or pain.

  • Have difficulty following or responding to commands that would limit the studyparticipation.

  • Be currently enrolled in another research study that is likely to affectparticipation in this research study.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: TBI - Intervention Group
Phase:
Study Start date:
January 01, 2024
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Kessler Foundation

    West Orange, New Jersey 07052
    United States

    Active - Recruiting

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