Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment for this study is temporarily paused due to study staff turnover.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VRTT With Feedback - Adults | Experimental | Adults aged 18-65 with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill with augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks. Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill with AR/VR feedback. |
|
| VRTT With Feedback - Older Adults | Experimental | Adults aged 65 and older with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill with augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks. Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill with AR/VR feedback. |
|
| VRTT Without Feedback - Adults | Active Comparator | Adults aged 18-65 with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill without augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks. Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill without AR/VR feedback. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C-Mill with AR/VR Guidance | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Recruitment rate is defined as the number of patients recruited on average for one month in one site. | Up to Week 10 |
| Enrollment Rate | Enrollment Rate defined as the percentage of recruited participants who enrolled in the study. | Up to Week 10 |
| Retention Rate | Retention rate defined as the percentage of enrolled participants who completed the study. | Up to Week 10 |
| Percentage of Participants who Adhere to 100% of Study Procedures | Up to Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Akhila Veerubhotla, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Shared data will be aggregated and deidentified. No IPD will be shared with other researchers.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| VRTT Without Feedback - Older Adults | Active Comparator | Adults aged 65 and older with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill without augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks. Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill without AR/VR feedback. |
|
|
| C-Mill without AR/VR Guidance | Device | 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 | Device | Used to conduct mobility assessments to assess temporal and spatial gait parameters during the 6-minute walk test. |
|
| Hunova | Device | Used to conduct fall-risk assessment. |
|
| Baseline, Week 7 |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |