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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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Cortical Activity
Change in Dynamic Gait Index (DGI)
Change in Montreal Cognitive Assessment Test
+7 more
Secondary outcome measures
Change in C-MILL Force Data
Change in Continuous Performance Task (CPT)
Change in Electromyography
+1 more

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
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 TTG group will walk on the treadmill (C-MILL) or stand on the treadmill (C-MILL) with no visual or auditory cues.
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.

Find a Location

Who is running the clinical trial?

Kessler FoundationLead Sponsor
174 Previous Clinical Trials
10,708 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Michigan
New Jersey
How old are they?
18 - 65
What site did they apply to?
Kessler Foundation
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study to Improve Ambulation in Individuals With TBI Using Virtual Reality -Based Treadmill Training
2020. "Study to Improve Ambulation in Individuals With TBI Using Virtual Reality -Based Treadmill Training". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05130658.
~3 spots leftby Sep 2024
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