High Intensity Step Training After Traumatic Brain Injury

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCraig Hospital

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Physical therapy

Treatment groups

111 Participants
are divided into 3 treatment groups

Sponsors and collaborators