NCT05702138 High Intensity Step Training After Traumatic Brain Injury
| NCT ID | NCT05702138 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Craig Hospital |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 111 participants |
| Start Date | 2023-03-20 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 111 participants in total. It began in 2023-03-20 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
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
Contact & Investigator
Candy Tefertiller, DPT, PhD
PRINCIPAL INVESTIGATOR
Craig Hospital
Frequently Asked Questions
Who can join the NCT05702138 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05702138 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05702138 currently recruiting?
Yes, NCT05702138 is actively recruiting participants. Contact the research team at mlundstern@craighospital.org for enrollment information.
Where is the NCT05702138 trial being conducted?
This trial is being conducted at Englewood, United States.
Who is sponsoring the NCT05702138 clinical trial?
NCT05702138 is sponsored by Craig Hospital. The principal investigator is Candy Tefertiller, DPT, PhD at Craig Hospital. The trial plans to enroll 111 participants.