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Physical Therapy for Traumatic Brain Injury (B-HIST Trial)
Phase 2
Recruiting
Led By Candy Tefertiller, DPT, PhD
Research Sponsored by Craig Hospital
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 6 weeks
Awards & highlights
B-HIST Trial Summary
This trial looks at how different types of therapeutic approaches can help improve mobility and balance after a TBI.
Who is the study for?
This trial is for adults who've had a traumatic brain injury (TBI) and are experiencing slower walking speeds. They should be within six months post-injury, weigh under 298 pounds, be shorter than 6'2", able to walk ten feet with minimal assistance, and have completed initial inpatient rehab for TBI. Those with uncontrolled health issues or participating in other trials can't join.Check my eligibility
What is being tested?
The study tests three methods to improve mobility after TBI: standard gait and balance training; high intensity step training (HIST); and HIST combined with virtual reality. It aims to see if these treatments also enhance cognitive functions alongside physical abilities like balance.See study design
What are the potential side effects?
While the trial primarily involves physical therapy interventions which typically have low risk, potential side effects may include muscle soreness, fatigue, joint pain or discomfort from the exercise equipment used during therapy sessions.
B-HIST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Walking Speed
Secondary outcome measures
Balance
Participant Enjoyment
Walking Endurance
Other outcome measures
Cognition
Side effects data
From 2011 Phase 4 trial • 127 Patients • NCT0125018410%
Hematomas
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lidocaine Injection + Physical Therapy
Physical Therapy
Lidocaine Injection
B-HIST Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: High Intensity Step Training with Virtual Reality (HISTVR)Experimental Treatment1 Intervention
The third arm combines virtual reality with HIST, designed to increase cortical excitability while concurrently activating the neuromuscular system.
Group II: High Intensity Step Training (HIST)Experimental Treatment1 Intervention
High Intensity Step Training (HIST) focuses on the repetition of stepping at higher cardiovascular intensities and yielding a greater number of steps per training session.
Group III: Conventional Gait and Balance Training (CGBT)Active Control1 Intervention
The current approach for walking retraining, Conventional Gait and Balance Training (CGBT) focuses on walking training in a variety of conditions, obstacle management training, functional independence training, strength training, and standing dynamic balance training.
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Who is running the clinical trial?
Craig HospitalLead Sponsor
40 Previous Clinical Trials
8,248 Total Patients Enrolled
Candy Tefertiller, DPT, PhDPrincipal InvestigatorCraig Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have seizures that my current medication cannot control.I do not have any unmanaged heart, lung, metabolic, or infection issues.I had a condition affecting my movement before my brain injury.I have an untreated or poorly managed mental health condition like depression.I have had a brain injury confirmed by loss of consciousness, memory issues, or physical exams.My injury occurred less than 6 months ago.My skin is healthy and unbroken where the treadmill harness will touch.I can walk ten feet with help from no more than two people or with a device.My doctor has approved me for hormone therapy.I walk slower than 1.4 meters per second.I am at least 18 years old.I have finished or am finishing my first rehab for a brain injury.
Research Study Groups:
This trial has the following groups:- Group 1: Conventional Gait and Balance Training (CGBT)
- Group 2: High Intensity Step Training (HIST)
- Group 3: High Intensity Step Training with Virtual Reality (HISTVR)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any spots available to join this research experiment?
"As per the information found on clinicaltrials.gov, this medical investigation is actively recruiting candidates. It was made publically available starting March 20th of 2023 and recently updated on May 3rd of that same year."
Answered by AI
What is the enrollment cap for this clinical experiment?
"Indeed, according to clinicaltrials.gov, this research study is actively recruiting participants. It was posted on March 20th 2023 and last edited on May 3rd of the same year. Altogether 111 subjects are required from a single site."
Answered by AI
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