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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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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

Walking Speed

Secondary study objectives

Balance

Participant Enjoyment

Walking Endurance

Other study objectives

Cognition

Side effects data

From 2011 Phase 4 trial • 127 Patients • NCT01250184

10%

Hematomas

100%

80%

60%

40%

20%

Study treatment Arm

Lidocaine Injection + Physical Therapy

Physical Therapy

Lidocaine Injection

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: 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.

Do I qualify?Apply below to find out