RECRUITING

High Intensity Step Training After Traumatic Brain Injury

Conditions

Traumatic Brain Injury balance mobility physical therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Improving Balance and Mobility After Traumatic Brain Injury: A Randomized Controlled Trial Evaluating High Intensity Step Training

Quick Facts

Study Start:2023-03-20

Study Completion:2027-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05702138

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Marissa Lundstern, MPH

CONTACT

303-789-8970

mlundstern@craighospital.org

Kaitlin Hays, DPT

CONTACT

khays@craighospital.org

Principal Investigator

Candy Tefertiller, DPT, PhD

PRINCIPAL_INVESTIGATOR

Craig Hospital

Study Locations (Sites)

Craig Hospital

Englewood, Colorado, 80113

United States

Collaborators and Investigators

Sponsor: Craig Hospital

Candy Tefertiller, DPT, PhD, PRINCIPAL_INVESTIGATOR, Craig Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-20

Study Completion Date2027-08-31

Study Record Updates

Study Start Date2023-03-20

Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

balance
mobility
physical therapy

Additional Relevant MeSH Terms

Traumatic Brain Injury