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High-Intensity Treadmill Training for Traumatic Brain Injury

N/A

Recruiting

Led By Courtney Perkins, DPT

Research Sponsored by Carilion Clinic

Eligibility Criteria Checklist

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

Must have

18-65 years old persons who are able to ambulate on treadmill with or without assistive devices and with or without need for bodyweight-support harness system

Persons with mild, moderate, or severe Traumatic Brain Injury at onset (first time or repeats)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through intervention and follow-up period, up to 8 weeks. this would be administered at the beginning, at the end of 2 weeks, at the end of 4 weeks of interventions, and finally at the end of 4 weeks following end of interventions for follow-up.

Awards & highlights

Study Summary

This trial studies the effects of high-intensity treadmill walking on those who have suffered TBI, with physical therapy treatment 3x/week for 4 weeks. Two groups, one with high-intensity and one with low-intensity. Follow up measures after one month.

Who is the study for?

This trial is for adults aged 18-65 with mild to severe Traumatic Brain Injury who can walk on a treadmill and communicate effectively. They must pass medical screenings, not be pregnant, speak English, have stable cardiac conditions, and no recent hospitalizations for acute issues or unstable orthopedic conditions.Check my eligibility

What is being tested?

The study compares high-intensity gait training (HIGT) on a treadmill versus low-intensity physical therapy in TBI patients. Participants are divided into two groups: one receives HIGT plus low-intensity therapy, the other only low-intensity therapy, three times weekly for four weeks.See study design

What are the potential side effects?

Potential side effects from the interventions may include muscle soreness, fatigue due to exercise intensity, joint or ligament strain from repetitive movements during gait training sessions.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old and can walk on a treadmill, with or without help.

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I have had a traumatic brain injury, regardless of its severity.

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I can make my own health decisions and agree to participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through intervention and follow-up period, up to 8 weeks. this would be administered at the beginning, at the end of 2 weeks, at the end of 4 weeks of interventions, and finally at the end of 4 weeks following end of interventions for follow-up.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through intervention and follow-up period, up to 8 weeks. this would be administered at the beginning, at the end of 2 weeks, at the end of 4 weeks of interventions, and finally at the end of 4 weeks following end of interventions for follow-up.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through intervention and follow-up period, up to 8 weeks. this would be administered at the beginning, at the end of 2 weeks, at the end of 4 weeks of interventions, and finally at the end of 4 weeks following end of interventions for follow-up. 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 (10mWT)

Berg Balance Scale (BBS)

Five Times Sit to Stand Test

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High-Intensity Treadmill Gait Training (HIGT)Experimental Treatment1 Intervention

High-intensity walking physical therapy with some low intensity therapy.

Group II: Low Intensity Physical TherapyActive Control1 Intervention

Low-intensity gait activities, exercises (such as lower extremity strength training with or without weights or electrical stimulation, sit to stands from a chair, mat exercises for upper/lower extremities and core strength, etc.), stretches, balance training activities, and other therapeutic activities (such as transfers, bed mobility training, etc.).

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Carilion ClinicLead Sponsor

71 Previous Clinical Trials

12,695 Total Patients Enrolled

Radford UniversityOTHER

5 Previous Clinical Trials

201 Total Patients Enrolled

Virginia Polytechnic Institute and State UniversityOTHER

142 Previous Clinical Trials

27,746 Total Patients Enrolled

Media Library

High-Intensity Gait Training Clinical Trial Eligibility Overview. Trial Name: NCT05622786 — N/A

Traumatic Brain Injury Research Study Groups: High-Intensity Treadmill Gait Training (HIGT), Low Intensity Physical Therapy

Traumatic Brain Injury Clinical Trial 2023: High-Intensity Gait Training Highlights & Side Effects. Trial Name: NCT05622786 — N/A

High-Intensity Gait Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05622786 — N/A

Frequently Asked Questions

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

What is the highest number of participants currently in this medical research endeavor?

"Indeed, clinicaltrials.gov's data confirms that this medical study has begun recruiting patients since October 7th 2022 and was most recently updated on November 11th 2022. In total, 60 participants are needed across a single site."

Answered by AI

Is this investigation engaging participants older than 25?

"The age range for those who may take part in this study is between 18 and 65 years old, according to the selection criteria."

Answered by AI

Is enrollment for this research open to new participants?

"This clinical trial is recruiting 60 individuals aged 18-65 that suffer from the gait impairment known as duck walk. In order to be enrolled, participants must pass medical and treadmill screenings; have experienced mild, moderate, or severe Traumatic brain injury at onset (either for first time of repeat); demonstrate their ability to communicate with investigators in a clear fashion; possess decision making capacity; and ambulate on the treadmill either with assistive devices or bodyweight support harness system."

Answered by AI

Is this research taking on additional volunteers at the moment?

"As evidenced by the clinicaltrials.gov website, this experiment is currently recruiting members for its trial cohort. The study was initially made available on October 7th 2022 and has recently been updated as of November 11th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of High-Intensity Gait Training Using a Treadmill on Locomotion Recovery in Traumatic Brain Injury Patients

Courtney Perkins, PT, DPT 2022. "Effect of High-Intensity Gait Training Using a Treadmill on Locomotion Recovery in Traumatic Brain Injury Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05622786.

All > Autonomic Dysfunction > Traumatic Brain Injury