High Intensity Step Training After Traumatic Brain Injury

ConditionTraumatic 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Physical therapy
Other intervention
The study evaluates three physical therapeutic approaches to improve mobility and balance after traumatic brain injury (TBI).

Treatment groups

111 Participants

are divided into 3 treatment groups

Group A: Conventional Gait and Balance Training (CGBT)Active comparator 1 intervention

Group B: High Intensity Step Training (HIST)Experimental treatment 1 intervention

Group C: High Intensity Step Training with Virtual Reality (HISTVR)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Walking Speed

10 Meter Walk Test (10MWT)

Time frame

6 Weeks

Secondary outcomes

Walking Endurance

6 Minute Walk Test (6MWT)

Time frame

6 Weeks

Balance

Functional Gait Assessment and Berg Balance Scale (FGA) and (BBS)

Time frame

6 Weeks

Participant Enjoyment

Physical Activity Enjoyment Scale

Time frame

6 Weeks

Other outcomes

Cognition

Brief Test of Adult Cognition by Telephone (BTACT):

Time frame

6 Weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Craig Hospital

Lead sponsor

Source ClinicalTrials.gov

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