CompletedNot Applicable

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

United States8 participantsStarted 2024-05-27

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Moderate to severe TBI that required inpatient rehabilitation program;
✓. at least one-year post-injury at time of consent;
✓. weight less than 298 pounds and able to fit appropriately in the treadmill system;
✓. intact skin (no open lesions/bandages) in the area of treadmill harness contact;
✓. able to walk ten feet requiring the assistance of no more than one person (bracing and assistive devices allowed);
✓. self-reports ongoing balance deficits;
✓. ability to follow directions/standardized instructions;
✓. minimum 18 years of age at consent

What they're measuring

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

Timeframe: 1 day

Acceptability of the intervention

Timeframe: 1 day

fNIRS Data Quality

Timeframe: 1 day

Trial details

NCT IDNCT06276894

SponsorCraig Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-28

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