RECRUITING

Virtual Reality Treadmill Training in Individuals With Traumatic Brain Injury

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Conditions

Traumatic Brain Injury

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Virtual Reality Treadmill Training in Individuals With Traumatic Brain Injur : A Pilot Study

Quick Facts

Study Start:2023-05-03
Study Completion:2025-02-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05721209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18 to 90 years old
  2. 2. diagnosed with a non-penetrating TBI
  3. 3. at least 12 months post most recent injury
  4. 4. self-reported balance deficits and fear of falls or at least 2 falls in the last one year
  5. 5. Able 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 English
  6. 6. Able to walk with minimal assistance or less (with bracing and assistive devices as needed)
  1. 1. history of severe cardiac disease
  2. 2. neuromuscular or neurological pathologies other than TBI that limit study participation
  3. 3. uncontrolled seizure disorder
  4. 4. weight greater than 135 kg or less than 25 kg
  5. 5. height greater than 6' 2''
  6. 6. severe cognitive, visual or hearing impairment where the patient is not able to follow the study instructions
  7. 7. open skin lesion or bandage in the area of C-Mill harness contact

Contacts and Locations

Study Contact

Akhila Veerubhotla, PhD
CONTACT
646-501-7777
Akhila.Veerubhotla@nyulangone.org

Principal Investigator

Akhila Veerubhotla, PhD
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

NYU Langone Health
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Akhila Veerubhotla, PhD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-03
Study Completion Date2025-02-15

Study Record Updates

Study Start Date2023-05-03
Study Completion Date2025-02-15

Terms related to this study

Additional Relevant MeSH Terms

  • Traumatic Brain Injury