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Behavioural Intervention

Robotic Balance Training for Traumatic Brain Injury

N/A

Recruiting

Led By Kiran Karunakaran

Research Sponsored by Kessler Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be able to stand unsupported for 5 minutes

Be between the ages of 18 and 65

Must not have

Weight above 300 lbs

Have a pre-existing condition resulting in significant disruption in alignment or function of the lower limb during standing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a balance training program to see if it can help improve balance and prevent falls in people who have had traumatic brain injuries (TBIs). There will be three groups involved: one group

Who is the study for?

This trial is for individuals who have experienced a traumatic brain injury (TBI) and are looking to improve their balance. Participants should be able to stand unaided. The study excludes those with other neurological disorders, recent surgery, or conditions that might interfere with balance training.

What is being tested?

The study tests a robotic balance training program's effectiveness on improving postural control in TBI patients. It includes three groups: one receiving the intervention, another TBI group not receiving it, and a non-disabled group for comparison.

What are the potential side effects?

Since this is a physical therapy intervention involving robotic-assisted exercises designed to improve balance, potential side effects may include muscle soreness or fatigue after sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can stand by myself for 5 minutes.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My weight is over 300 lbs.

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I have a condition that significantly affects my leg's function or alignment when standing.

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I had balance issues before my brain injury.

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My blood pressure goes up and down.

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I have a seizure disorder.

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I have severe heart issues, like a recent heart attack or heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

10 Meter walk test

Balance

Berg Balance Assessment

+7 more

Secondary study objectives

community ambulation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: TBI - Intervention GroupExperimental Treatment1 Intervention

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.

Group II: Participants without disability groupActive Control1 Intervention

Participants will receive no intervention

Group III: TBI - Non Intervention GroupActive Control1 Intervention

Participants will receive no intervention

0 / 8Eligibility criteria met