search
Back to results

High Intensity Step Training After Traumatic Brain Injury (B-HIST)

Primary Purpose

Traumatic Brain Injury

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Physical therapy
Sponsored by
Craig Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring balance, mobility, physical therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 6m 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 one person 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 Out of PTA (> 25 O-Log score for three consecutive days) 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

Sites / Locations

  • Craig HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Conventional Gait and Balance Training (CGBT)

High Intensity Step Training (HIST)

High Intensity Step Training with Virtual Reality (HISTVR)

Arm Description

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.

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.

The third arm combines virtual reality with HIST, designed to increase cortical excitability while concurrently activating the neuromuscular system.

Outcomes

Primary Outcome Measures

Walking Speed
10 Meter Walk Test (10MWT)

Secondary Outcome Measures

Walking Endurance
6 Minute Walk Test (6MWT)
Balance
Functional Gait Assessment and Berg Balance Scale (FGA) and (BBS)
Participant Enjoyment
Physical Activity Enjoyment Scale

Full Information

First Posted
January 18, 2023
Last Updated
May 3, 2023
Sponsor
Craig Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05702138
Brief Title
High Intensity Step Training After Traumatic Brain Injury
Acronym
B-HIST
Official Title
Improving Balance and Mobility After Traumatic Brain Injury: A Randomized Controlled Trial Evaluating High Intensity Step Training
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Craig Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
balance, mobility, physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
111 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Gait and Balance Training (CGBT)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
High Intensity Step Training (HIST)
Arm Type
Experimental
Arm Description
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.
Arm Title
High Intensity Step Training with Virtual Reality (HISTVR)
Arm Type
Experimental
Arm Description
The third arm combines virtual reality with HIST, designed to increase cortical excitability while concurrently activating the neuromuscular system.
Intervention Type
Other
Intervention Name(s)
Physical therapy
Intervention Description
The study evaluates three physical therapeutic approaches to improve mobility and balance after traumatic brain injury (TBI).
Primary Outcome Measure Information:
Title
Walking Speed
Description
10 Meter Walk Test (10MWT)
Time Frame
6 Weeks
Secondary Outcome Measure Information:
Title
Walking Endurance
Description
6 Minute Walk Test (6MWT)
Time Frame
6 Weeks
Title
Balance
Description
Functional Gait Assessment and Berg Balance Scale (FGA) and (BBS)
Time Frame
6 Weeks
Title
Participant Enjoyment
Description
Physical Activity Enjoyment Scale
Time Frame
6 Weeks
Other Pre-specified Outcome Measures:
Title
Cognition
Description
Brief Test of Adult Cognition by Telephone (BTACT):
Time Frame
6 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 6m 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 one person 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 Out of PTA (> 25 O-Log score for three consecutive days) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marissa Lundstern, MPH
Phone
303-789-8970
Email
mlundstern@craighospital.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kaitlin Hays, DPT
Email
khays@craighospital.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Candy Tefertiller, DPT, PhD
Organizational Affiliation
Craig Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Craig Hospital
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marissa Lundstern, MPH
Phone
303-789-8970
Email
mlundstern@craighospital.org
First Name & Middle Initial & Last Name & Degree
Katie Hays, DPT
Phone
303-789-8000
Email
khays@craighospital.org

12. IPD Sharing Statement

Learn more about this trial

High Intensity Step Training After Traumatic Brain Injury

We'll reach out to this number within 24 hrs