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Behavioural Intervention

TBI - Intervention Group for Traumatic Brain Injury

N/A

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

10 Meter walk test

Balance

Berg Balance Assessment

+7 more

Secondary outcome measures

community ambulation

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kessler FoundationLead Sponsor

173 Previous Clinical Trials

10,678 Total Patients Enrolled

Kiran KarunakaranPrincipal InvestigatorKessler Foundation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age range for participants in this medical study inclusive of individuals below the age of 20?

"The trial is seeking individuals within the age range of adulthood, starting from 18 years old and concluding at 65 years old."

Answered by AI

Are patients currently able to participate in this ongoing research study?

"Based on the information provided on clinicaltrials.gov, this particular trial is not currently seeking participants. The study was initially posted on January 1st, 2024 and last edited on December 14th, 2023. Despite this trial being inactive for recruitment purposes at present, there are a total of 339 other ongoing clinical trials that are actively enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Kiran Karunakaran 2024. "Robotic Balance Training to Improve Postural Control and Balance Post-Traumatic Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06184295.

All > Tbi > Traumatic Brain Injury