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Not Yet Recruiting
NCT05721209
Virtual Reality Treadmill Training in Individuals With Traumatic Brain Injury
Conditions: Traumatic Brain Injury
Sex: All
Ages: 18 Years – 90 Years
Phase: NA
Enrollment: 40
Sponsor: NYU Langone Health
Location: United States
Summary
This pilot study aims to determine the feasibility of a virtual reality treadmill training intervention in individuals with Traumatic Brain Injury (TBI).
Participants will be stratified based on age into adults' group or older adults' group and then randomized into the virtual reality treadmill training (intervention) group with feedback or the treadmill training (control) group.
This pilot study will also provide preliminary evidence on the impact of the virtual reality treadmill training on mobility, balance, fear of falls, fall risk, attention and physical activity in the community in individuals with TBI.
The data collected in this pilot study will also help to estimate sample size for subsequent large clinical trial.
Eligibility Criteria
Inclusion Criteria:18 to 90 years olddiagnosed with a non-penetrating TBIat least 12 months post most recent injuryself-reported balance deficits and fear of falls or at least 2 falls in the last one yearAble to understand and speak English language to respond, understand and comply with study procedures throughout the 10-week study period and fill out the study questionnaires in EnglishAble to walk with minimal assistance or less (with bracing and assistive devices as needed)Exclusion Criteria:history of severe cardiac diseaseneuromuscular or neurological pathologies other than TBI that limit study participationuncontrolled seizure disorderweight greater than 135 kg or less than 25 kgheight greater than 6' 2''severe cognitive, visual or hearing impairment where the patient is not able to follow the study instructionsopen skin lesion or bandage in the area of C-Mill harness contact
Source: ClinicalTrials.gov (NCT05721209). StuddyBuddy aggregates publicly available trial information.