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High Intensity Stepping Training for Traumatic Brain Injury (TBI_IU Trial)

N/A

Waitlist Available

Led By George Hornby, PhD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline 1, post 1 after 6 weeks, baseline 2, post 6 weeks

Awards & highlights

TBI_IU Trial Summary

This trial will test two different walking training interventions to see which is more effective for people recovering from a traumatic brain injury. It will last up to 6 months and include testing sessions that last 3-4 hours.

Eligible Conditions

Traumatic Brain Injury

TBI_IU Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline 1, post 1 after 6 weeks, baseline 2, post 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline 1, post 1 after 6 weeks, baseline 2, post 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline 1, post 1 after 6 weeks, baseline 2, post 6 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

Change in Endurance

Change in Gait speed

Secondary outcome measures

Change in Strength

Change in gait quality

Change in metabolic capacity

TBI_IU Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High Intensity Stepping TrainingExperimental Treatment1 Intervention

The primary goal will be to perform continuous stepping while maintaining HR within 70-85% maximum predicted HR (if patients are deconditioned, PTs will gradually increase intensity to desired levels as tolerated). We will also record Ratings of Perceived Exertion (RPE) every 3-5 minutes, with goals of 15-18. Sessions will be divided into ~10 minute increments (~25% of sessions) between speed-dependent treadmill training (described above for treadmill stepping), skill-dependent treadmill training, overground training, and stair climbing.

Group II: Conventional TherapyActive Control1 Intervention

Participants provided conventional therapy will perform various standardized exercise tasks during 40 minutes of 1 hr sessions. The type of therapeutic activities is based on published normative data of typical activities performed during clinical physical therapy sessions with focus on strengthening activities (25% of session); balance activities (25%); locomotor activities (25%), and combined stretching exercises (10-15%) and transfers (10-15%). Intensity of activities will be targeted at 30-40% of their HR reserve in attempts to maintain consistent intensities between training groups.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

High Intensity Stepping Training

2020

N/A

~20

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Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,141 Total Patients Enrolled

George Hornby, PhDPrincipal Investigator - Indiana University

Indiana University

Frequently Asked Questions

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

Does the research protocol accept applicants aged 35 or over?

"The age range for enrollment in this clinical trial is 18 to 75, as declared by the inclusion criteria."

Answered by AI

Could I be a subject in this investigation?

"This research is enrolling 20 individuals who have suffered a traumatic brain injury within the past 6 months, and are between 18-75 years of age. The primary criteria for eligibility also requires that participants be able to ambulate independently."

Answered by AI

What is the current sample size for this experimental treatment?

"Affirmative. The clinical trial is still recruiting, as evidenced by records on clinicaltrials.gov which outline the study's initial posting date of August 1st 2020 and its most recent update being November 17th 2022. Currently, 20 people are needed to participate in this single site experiment."

Answered by AI

Are there any vacancies for prospective participants in this trial?

"According to the information on ClinicalTrials.gov, this course of research is presently recruiting volunteers; it was first advertised in August 2020 and most recently updated November 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Locomotor Recovery Following Traumatic Brain Injury

George Hornby 2020. "Locomotor Recovery Following Traumatic Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04503473.