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Virtual Reality Treadmill Training in Individuals With Traumatic Brain Injury

Virtual Reality Treadmill Training in Individuals With Traumatic Brain Injury

Recruiting
18-90 years
All
Phase N/A

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Overview

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

Inclusion Criteria:

  1. 18 to 90 years old
  2. diagnosed with a non-penetrating TBI
  3. at least 12 months post most recent injury
  4. self-reported balance deficits and fear of falls or at least 2 falls in the last one year
  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. Able to walk with minimal assistance or less (with bracing and assistive devices as needed)

Exclusion Criteria:

  1. history of severe cardiac disease
  2. neuromuscular or neurological pathologies other than TBI that limit study participation
  3. uncontrolled seizure disorder
  4. weight greater than 135 kg or less than 25 kg
  5. height greater than 6' 2''
  6. severe cognitive, visual or hearing impairment where the patient is not able to follow the study instructions
  7. open skin lesion or bandage in the area of C-Mill harness contact

Study details
    Traumatic Brain Injury

NCT05721209

NYU Langone Health

15 May 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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