Clinical trial NCT05702138: High Intensity Step Training After Traumatic Brain Injury
Official title: Improving Balance and Mobility After Traumatic Brain Injury: A Randomized Controlled Trial Evaluating High Intensity Step Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Traumatic Brain Injury
Keywords: balance
mobility
physical therapy
Lead sponsor: Craig Hospital
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Walking Speed
timeFrame: 6 Weeks
Secondary outcomes:
measure: Walking Endurance
timeFrame: 6 Weeks
measure: Balance
timeFrame: 6 Weeks
measure: Participant Enjoyment
timeFrame: 6 Weeks
Other outcomes:
measure: Cognition
timeFrame: 6 Weeks
Locations:
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
Study officials:
affiliation: Craig Hospital
name: Candy Tefertiller, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: