Traumatic Brain InjuryPhase 2B-HISTNCT05702138
High Intensity Step Training After Traumatic Brain Injury
A Phase 2 study testing Physical therapy in people with Traumatic Brain Injury, run by Craig Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2023to 31 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kaitlin Hays, DPT contact
United States1 site, 1 recruiting
- Recruiting
Craig Hospital
Englewood, Colorado, 80113
Marissa Lundstern, MPH, 303-789-8970, mlundstern@craighospital.org
Katie Hays, DPT, 303-789-8000, khays@craighospital.org
About this study
Official title: Improving Balance and Mobility After Traumatic Brain Injury: A Randomized Controlled Trial Evaluating High Intensity Step Training
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.
Read the detailed description
Individuals with traumatic brain injury (TBI) walk more slowly, demonstrate greater imbalance, and have reduced endurance. There is strong evidence that a single bout of physical activity has substantial cognitive benefits among older adults and stroke survivors, yet similar studies have not been conducted in TBI. 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 TBI: the first approach, Conventional Gait and Balance Training (CGBT), represents the current approach for walking retraining. CGBT focuses on walking training in a variety of conditions, obstacle management training, functional independence training, strength training, and standing dynamic balance training. The second approach, 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 with promising evidence already published in stroke and spinal cord injury (SCI). The third approach combines virtual reality with HIST, designed to increase cortical excitability while concurrently activating the neuromuscular system.
- Conditions
- Traumatic Brain Injury
- Being tested
- Physical therapy
- Keywords
- balance, mobility, physical therapy
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapyOther
The study evaluates three physical therapeutic approaches to improve mobility and balance after traumatic brain injury (TBI).
| Study group | Role | What they receive |
|---|---|---|
| Conventional Gait and Balance Training (CGBT) | Active comparator | 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. Receives: Other: Physical therapy |
| High Intensity Step Training (HIST) | Experimental | 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. Receives: Other: Physical therapy |
| High Intensity Step Training with Virtual Reality (HISTVR) | Experimental | The third arm combines virtual reality with HIST, designed to increase cortical excitability while concurrently activating the neuromuscular system. Receives: Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Speed
10 Meter Walk Test (10MWT)
Measured: 6 Weeks
Secondary outcomes (3)
Walking Endurance
6 Minute Walk Test (6MWT)
Measured: 6 Weeks
Balance
Functional Gait Assessment and Berg Balance Scale (FGA) and (BBS)
Measured: 6 Weeks
Participant Enjoyment
Physical Activity Enjoyment Scale
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start20 Mar 2023
- Primary completionDec 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Candy Tefertiller, DPT, PhD, Principal investigator, Craig Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702138
- Sponsor's protocol ID
- IRB#1947316-1
- Acronym
- B-HIST
- Status last verified
- Oct 2026
- First submitted
- 18 Jan 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Balance and Mobility After Traumatic Brain Injury: A Randomized Controlled Trial Evaluating High Intensity Step Training
- ClinicalTrials.gov ID
- NCT05702138
- Acronym / sponsor ID
- B-HIST / IRB#1947316-1
- Conditions
- Traumatic Brain Injury
- Keywords
- balance, mobility, physical therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Craig HospitalUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Individuals with traumatic brain injury (TBI) walk more slowly, demonstrate greater imbalance, and have reduced endurance. There is strong evidence that a single bout of physical activity has substantial cognitive benefits among older adults and stroke survivors, yet similar studies have not been conducted in TBI. 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 TBI: the first approach, Conventional Gait and Balance Training (CGBT), represents the current approach for walking retraining. CGBT focuses on walking training in a variety of conditions, obstacle management training, functional independence training, strength training, and standing dynamic balance training. The second approach, 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 with promising evidence already published in stroke and spinal cord injury (SCI). The third approach combines virtual reality with HIST, designed to increase cortical excitability while concurrently activating the neuromuscular system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Gait and Balance Training (CGBT) | Active comparator | Other: Physical therapyThe 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. |
| High Intensity Step Training (HIST) | Experimental | Other: Physical therapyHigh Intensity Step Training (HIST) focuses on the repetition of stepping at higher cardiovascular intensities and yielding a greater number of steps per training session. |
| High Intensity Step Training with Virtual Reality (HISTVR) | Experimental | Other: Physical therapyThe third arm combines virtual reality with HIST, designed to increase cortical excitability while concurrently activating the neuromuscular system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical therapyThe study evaluates three physical therapeutic approaches to improve mobility and balance after traumatic brain injury (TBI). | Other | Conventional Gait and Balance Training (CGBT), High Intensity Step Training (HIST), High Intensity Step Training with Virtual Reality (HISTVR) |
Primary outcome
Walking Speed
Time frame: 6 Weeks
10 Meter Walk Test (10MWT)
3 secondary outcomes
Walking Endurance
Time frame: 6 Weeks
Balance
Time frame: 6 Weeks
Participant Enjoyment
Time frame: 6 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaitlin Hays, DPT contact
Candy Tefertiller, DPT, PhD principal investigator
Craig Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Physical therapy in people with Traumatic Brain Injury, run by Craig Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marissa Lundstern, MPH (303-789-8970, mlundstern@craighospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Speed (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.