Virtual Reality Walking for Traumatic Brain Injury
(fNIRS Trial)
ML
CT
Overseen ByCandy Tefertiller, PT, DPT, PhD, NCS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Craig Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
The purpose of this study is to evaluate the safety and feasibility of using a portable neuroimaging device called functional near-infrared spectroscopy (fNIRS) to successfully analyze fNIRS data in individuals with chronic TBI during treadmill training augmented with VR.
Research Team
CT
Candy Tefertiller, PT, DPT, PhD, NCS
Principal Investigator
Craig Hospital
Eligibility Criteria
This trial is for individuals with chronic traumatic brain injury (TBI) who are able to participate in treadmill training. Specific eligibility criteria aren't provided, but typically participants must be medically stable and capable of giving informed consent.Inclusion Criteria
Weight less than 298 pounds and able to fit appropriately in the treadmill system
Ability to follow directions/standardized instructions
I can walk ten feet with help from one person or with a device.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants undergo a single session of treadmill training with and without VR while wearing the fNIRS device
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after the intervention
1-2 weeks
Treatment Details
Interventions
- Functional Near-Infrared Spectroscopy (fNIRS)
Trial Overview The study is testing the use of a portable brain-scanning device called fNIRS during treadmill exercises that may or may not include virtual reality (VR). The goal is to see if fNIRS can effectively measure brain activity in people with TBI under these conditions.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Stepping on a Virtual Reality Treadmill with a Functional Near-infrared Spectroscopy (fNIRS) DeviceExperimental Treatment2 Interventions
This is a single-arm safety and feasibility study that will enroll up to 15 participants. Those meeting inclusion/exclusion criteria will be invited to enroll in the study. Following a thorough informed consent process, each participant will participate in one session of data acquisition. fNIRS data will be acquired with the NIRSport2, which is a fully-portable system as the device (weighs less than 2 pounds) is secured to the participant's back with backpack-like straps. Following signal optimization and signal quality checks, baseline fNIRS data will be obtained during 60-second periods of quiet, static standing. Then, each participant will complete up to 24 minutes of stepping on a treadmill with and without VR wearing the fNIRS cap. This training will be carried out in two 12-minute sessions with individuals being offered a sitting rest break in between. Training will be completed using the Motek C-Mill™ treadmill, which provides optional body weight support and VR feedback.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Craig Hospital
Lead Sponsor
Trials
45
Recruited
8,400+
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