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

Part of paid clinical trials in West Orange, New Jersey.

Sponsor
Kessler Foundation
Study ID
NCT06184295
Status
Recruiting
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Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • TBI - Intervention Group — DEVICE
    The participants will receive 10 customized robotic balance training sessions to improve balance using the Hunova robotic device. Each session will last for up to 1.5 hours. The training may include standing or sitting on the robotic balance platform and performing the following tasks: maintaining balance when the platform becomes unstable or moving in various directions, or in an inclination; these tasks may be performed as instructed with eyes open or eyes closed condition; move in different directions to reach targets with my hands; stand on one leg or heel to toe and maintain balance; perform head or torso rotation while standing or sitting. All training will be performed with an overhead harness and a spotter will be present at all times.

Study Details

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.

Key Dates

Start date
Jan 1, 2024
Status verified
Dec 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TBI - Intervention Group
    The participants will receive 10 customized robotic balance training sessions to improve balance using the Hunova robotic device. Each session will last for up to 1.5 hours. The training may include standing or sitting on the robotic balance platform and performing the following tasks: maintaining balance when the platform becomes unstable or moving in various directions, or in an inclination; these tasks may be performed as instructed with eyes open or eyes closed condition; move in different directions to reach targets with my hands; stand on one leg or heel to toe and maintain balance; perform head or torso rotation while standing or sitting. All training will be performed with an overhead harness and a spotter will be present at all times.
  • No Intervention: TBI - Non Intervention Group
    Participants will receive no intervention
  • No Intervention: Participants without disability group
    Participants will receive no intervention

Primary Outcome Measure

Berg Balance Assessment [ Time Frame: 5 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kessler FoundationWest OrangeNew Jersey07052
Kiran Karunakaran, PhD
973-324-3590
Kiran Karunakaran, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Kessler Foundation· West Orange, NJ

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