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Behavioural Intervention

Stepping on a Virtual Reality Treadmill with a Functional Near-infrared Spectroscopy (fNIRS) Device for Traumatic Brain Injury (fNIRS Trial)

N/A

Waitlist Available

Led By Candy Tefertiller, PT, DPT, PhD, NCS

Research Sponsored by Craig Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to walk ten feet requiring the assistance of no more than one person (bracing and assistive devices allowed)

Minimum 18 years of age at consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

fNIRS Trial Summary

This trial aims to test if a portable neuroimaging device called functional near-infrared spectroscopy (fNIRS) can safely and effectively analyze brain data in people with chronic traumatic brain injury while they

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves non-invasive monitoring and physical therapy, side effects might include typical exercise-related discomforts such as muscle soreness or fatigue. VR could potentially cause dizziness or nausea in some individuals.

fNIRS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk ten feet with help from one person or with a device.

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I am at least 18 years old.

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I often feel unsteady or have trouble keeping my balance.

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I had a serious brain injury and needed hospital rehab.

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My skin is healthy and unbroken where the treadmill harness will touch.

fNIRS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of the intervention

Incidence of Treatment-Related Adverse Events (e.g., Safety and Tolerability)

fNIRS Data Quality

fNIRS Trial Design

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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Craig HospitalLead Sponsor

40 Previous Clinical Trials

8,344 Total Patients Enrolled

Candy Tefertiller, PT, DPT, PhD, NCSPrincipal InvestigatorCraig Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients to participate in this clinical trial?

"The trial registered on clinicaltrials.gov, posted initially on March 1st, 2024 and revised lastly on February 23rd, 2024 is presently not seeking participants. Despite this particular study being inactive for recruitment, there are currently 350 other trials actively enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Functional Near-Infrared Spectroscopy (fNIRS) Assessing Neural Activity During Virtual Reality Walking Intervention

Candace Tefertiller 2024. "Functional Near-Infrared Spectroscopy (fNIRS) Assessing Neural Activity During Virtual Reality Walking Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06276894.