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Behavioural Intervention

Virtual Reality Treadmill Training for Traumatic Brain Injury

N/A

Recruiting

Research Sponsored by Kessler Foundation

Eligibility Criteria Checklist

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

Must have

Inclusion/

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 training sessions

Awards & highlights

No Placebo-Only Group

Summary

This trial evaluates the effectiveness of VR-based treadmill training on walking, cognition, and brain activity in individuals with brain injury.

Who is the study for?

This trial is for individuals with traumatic brain injury (TBI) who are able to walk or stand on a treadmill. It's also open to healthy people without TBI for comparison. Participants must be willing to undergo multiple training and data collection sessions, and use a safety harness during exercises.

What is being tested?

The study tests if virtual reality-based treadmill training improves walking in those with TBI. There are three groups: one using VR cues while walking, another just walking on the treadmill without cues, and a healthy control group for baseline comparisons.

What are the potential side effects?

There may not be direct side effects from the interventions since they involve physical training; however, there's always a risk of fatigue or muscle soreness from exercise, and falls despite safety measures like harnesses and spotters.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 training sessions

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 training sessions

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 training sessions for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Cortical Activity

Change in Dynamic Gait Index (DGI)

Change in Montreal Cognitive Assessment Test

+7 more

Secondary study objectives

Change in C-MILL Force Data

Change in Continuous Performance Task (CPT)

Change in Electromyography

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: C-MILL training groupExperimental Treatment1 Intervention

The participants will be screened for the inclusion/exclusion criteria and consented during the first session. They will participate in two data collection sessions, one before the training and one after the training. The participants will undergo 10 training sessions. Individuals in the CTG will receive gait and balance training sessions with the virtual reality and auditory cues using C-MILL (such as walking on a pathway, obstacle avoidance, lateral balance etc.) to provide task specific training. C-Mill (Motekforce Link, Amsterdam, The Netherlands) is an instrumented treadmill that uses visual (on the screen as well on the treadmill) and acoustic cues for gait and balance training. The C-Mill allows for gait and balance adaptability strategy as it can provide obstacle avoidance environments, change in speed and various walking pathways in a safe and controlled environment.

Group II: Treadmill training group (TTG)Active Control1 Intervention

Group III: Healthy ControlActive Control1 Intervention

HCG will participate in up to four sessions. The participants will be screened for the inclusion/exclusion criteria and consented during the first session. They will participate in two data collection sessions and one C-MILL session.

0 / 1Eligibility criteria met