NCT05702138 · Craig Hospital
High Intensity Step Training After Traumatic Brain Injury
(B-HIST)
What this study is about
This study will explore whether the types and intensity of the interventions being delivered will yield measurable cognitive benefits in addition to improved mobility and balance.
View original scientific description
This study will explore whether the types and intensity of the interventions being delivered will yield measurable cognitive benefits in addition to improved mobility and balance. The study evaluates three therapeutic approaches to improve mobility and balance after traumatic brain injury (TBI): Conventional Gait and Balance Training, high intensity step training, and high intensity step training with virtual reality.
Interventions
OTHER
Physical therapy
The study evaluates three physical therapeutic approaches to improve mobility and balance after traumatic brain injury (TBI).
Primary outcome measures
Walking Speed
Time frame: 6 Weeks
10 Meter Walk Test (10MWT)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- TBI definition: damage to brain tissue caused by an external mechanical force as evidenced by loss of consciousness (LOC) or post traumatic amnesia (PTA) due to brain trauma or by objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination
- Less than 6 months post injury at time of consent
- Weight less than 298 pounds and height less than 6'2" (based on treadmill contraindications)
- Intact skin (no open lesions/bandages) in the area of treadmill harness contact
- Able to walk ten feet requiring the physical assistance of not more than two people and/or bracing, assistive devices
- Impaired walking speed of \< than 1.4 meters/second
- Ability to follow directions/standardized instructions
- Minimum 18 years of age at consent
- Completing or have completed initial inpatient rehabilitation for TBI
- O-Log score of at least 20
- Medically cleared for HIST by a physician
Exclusion criteria
- Uncontrolled cardiopulmonary, metabolic, or infectious disorder
- History of orthopedic or additional neurological disorder that limited motor function before TBI
- Any reason that, in the opinion of the study investigators or medical team, would interfere with completing the study protocol such as behavioral concerns
- Uncontrolled seizure disorder
- Pregnant or lactating females
- Current participation in any other interventional trials
- History of an untreated or a poorly controlled psychiatric condition such as depression, schizophrenia, or bipolar disorder
Where
- Englewood, Colorado
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 21, 2025 · Source of record for eligibility and locations