Virtual Reality Treadmill Training in Individuals With Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05721209
• Other study ID #: 22-01576
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2023
• Est. completion date: February 15, 2025

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: Akhila Veerubhotla, PhD
• Phone: 646-501-7777
• Email: Akhila.Veerubhotla[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 15, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

Device:
• C-Mill with AR/VR Guidance
Treadmill training system that is a combination of an instrumented treadmill, front display, and a floor projector, allowing functional gait and balance training. The AR/VR feedback will include computer generated obstacles and objects projected as images on the treadmill. Participants will be asked to use these projections as stepping cues and step on some images of objects while avoiding stepping on the images of obstacles.
• C-Mill without AR/VR Guidance
Treadmill training system that is a combination of an instrumented treadmill, front display, and a floor projector, allowing functional gait and balance training.
• Zeno 3-Layer Walkway
Used to conduct mobility assessments to assess temporal and spatial gait parameters during the 6-minute walk test.
• Hunova
Used to conduct fall-risk assessment.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate	Recruitment rate is defined as the number of patients recruited on average for one month in one site.	Up to Week 10
Primary	Enrollment Rate	Enrollment Rate defined as the percentage of recruited participants who enrolled in the study.	Up to Week 10
Primary	Retention Rate	Retention rate defined as the percentage of enrolled participants who completed the study.	Up to Week 10
Primary	Percentage of Participants who Adhere to 100% of Study Procedures		Up to Week 10
Secondary	Change from Baseline in Falls Self-Efficacy Scale (FES-I) Score by Final Intervention Visit	FES-I is a 16-item self-assessment of fear of falls in different situations. Each item is ranked on a 4-point Likert scale ranging from 1 (Not at all concerned) to 4 (Very concerned). The total score is the sum of responses and ranges from 16 to 64; lower scores indicate lower fear of falls. A decrease in scores indicates fear of falls decreased over the observational period.	Baseline, Week 7