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Virtual Reality Treadmill Training in Individuals With Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
C-Mill with AR/VR Guidance
C-Mill without AR/VR Guidance
Zeno 3-Layer Walkway
Hunova
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 to 90 years old diagnosed with a non-penetrating TBI at least 12 months post most recent injury self-reported balance deficits and fear of falls or at least 2 falls in the last one year 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 Able to walk with minimal assistance or less (with bracing and assistive devices as needed) Exclusion Criteria: history of severe cardiac disease neuromuscular or neurological pathologies other than TBI that limit study participation uncontrolled seizure disorder weight greater than 135 kg or less than 25 kg height greater than 6' 2'' severe cognitive, visual or hearing impairment where the patient is not able to follow the study instructions open skin lesion or bandage in the area of C-Mill harness contact

Sites / Locations

  • NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

VRTT With Feedback - Adults

VRTT With Feedback - Older Adults

VRTT Without Feedback - Adults

VRTT Without Feedback - Older Adults

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Recruitment Rate
Recruitment rate is defined as the number of patients recruited on average for one month in one site.
Enrollment Rate
Enrollment Rate defined as the percentage of recruited participants who enrolled in the study.
Retention Rate
Retention rate defined as the percentage of enrolled participants who completed the study.
Percentage of Participants who Adhere to 100% of Study Procedures

Secondary Outcome Measures

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.

Full Information

First Posted
January 31, 2023
Last Updated
June 13, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT05721209
Brief Title
Virtual Reality Treadmill Training in Individuals With Traumatic Brain Injury
Official Title
Virtual Reality Treadmill Training in Individuals With Traumatic Brain Injur : A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2023 (Actual)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
February 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VRTT With Feedback - Adults
Arm Type
Experimental
Arm Description
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.
Arm Title
VRTT With Feedback - Older Adults
Arm Type
Experimental
Arm Description
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.
Arm Title
VRTT Without Feedback - Adults
Arm Type
Active Comparator
Arm Description
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.
Arm Title
VRTT Without Feedback - Older Adults
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
C-Mill with AR/VR Guidance
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
C-Mill without AR/VR Guidance
Intervention Description
Treadmill training system that is a combination of an instrumented treadmill, front display, and a floor projector, allowing functional gait and balance training.
Intervention Type
Device
Intervention Name(s)
Zeno 3-Layer Walkway
Intervention Description
Used to conduct mobility assessments to assess temporal and spatial gait parameters during the 6-minute walk test.
Intervention Type
Device
Intervention Name(s)
Hunova
Intervention Description
Used to conduct fall-risk assessment.
Primary Outcome Measure Information:
Title
Recruitment Rate
Description
Recruitment rate is defined as the number of patients recruited on average for one month in one site.
Time Frame
Up to Week 10
Title
Enrollment Rate
Description
Enrollment Rate defined as the percentage of recruited participants who enrolled in the study.
Time Frame
Up to Week 10
Title
Retention Rate
Description
Retention rate defined as the percentage of enrolled participants who completed the study.
Time Frame
Up to Week 10
Title
Percentage of Participants who Adhere to 100% of Study Procedures
Time Frame
Up to Week 10
Secondary Outcome Measure Information:
Title
Change from Baseline in Falls Self-Efficacy Scale (FES-I) Score by Final Intervention Visit
Description
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.
Time Frame
Baseline, Week 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 to 90 years old diagnosed with a non-penetrating TBI at least 12 months post most recent injury self-reported balance deficits and fear of falls or at least 2 falls in the last one year 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 Able to walk with minimal assistance or less (with bracing and assistive devices as needed) Exclusion Criteria: history of severe cardiac disease neuromuscular or neurological pathologies other than TBI that limit study participation uncontrolled seizure disorder weight greater than 135 kg or less than 25 kg height greater than 6' 2'' severe cognitive, visual or hearing impairment where the patient is not able to follow the study instructions open skin lesion or bandage in the area of C-Mill harness contact
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Akhila Veerubhotla, PhD
Phone
646-501-7777
Email
Akhila.Veerubhotla@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akhila Veerubhotla, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akhila Veerubhotla, PhD
Phone
646-501-7777
Email
Akhila.Veerubhotla@nyulangone.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Shared data will be aggregated and deidentified. No IPD will be shared with other researchers.

Learn more about this trial

Virtual Reality Treadmill Training in Individuals With Traumatic Brain Injury

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