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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05721209
Other study ID # 22-01576
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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