Traumatic Brain Injury
Conditions
Brief 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.
Interventions
DEVICEC-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.
DEVICEC-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.
DEVICEZeno 3-Layer Walkway
Used to conduct mobility assessments to assess temporal and spatial gait parameters during the 6-minute walk test.
DEVICEHunova
Used to conduct fall-risk assessment.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | Up to Week 10 | Recruitment rate is defined as the number of patients recruited on average for one month in one site. |
| Enrollment Rate | Up to Week 10 | Enrollment Rate defined as the percentage of recruited participants who enrolled in the study. |
| Retention Rate | Up to Week 10 | Retention rate defined as the percentage of enrolled participants who completed the study. |
| Percentage of Participants who Adhere to 100% of Study Procedures | Up to Week 10 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Falls Self-Efficacy Scale (FES-I) Score by Final Intervention Visit | Baseline, Week 7 | 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. |
Countries
United States
Outcome results
None listed