Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes

NCT06727942 | Recruiting FDA Device

• 1 other identifier: 2021-0678
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Age-associated motor and cognitive deficits increase the risk of falls, a major cause of morbidity and mortality. Emerging evidence suggests that inflammatory mediators lead to impaired functional capacity and frailty in the elderly and suggests that immune system mediated inflammation in the brain play an important role in cognitive decline. Substantial literature has also demonstrated that age-targeted physical activity training are promising strategies for promoting the motor-cognitive process across the adult lifespan. Recently, the virtual reality (VR) application has been implemented in the neuropsychological rehabilitation settings suggesting that the VR-infused daily living activities may benefit the transfer of intervention outcomes and to promote autonomy in function of daily living such as cooking or grocery shopping. However, it remains unclear the effect of the VR-based exercise intervention (motor-cognitive impact) on older adults' cognitive function and fall prevention. The literature suggests that the similarity of VR exercises with real life activities may improve generalizability by extending the transfer of gains of training to everyday living and promote some aspects of quality of life in older adults. It is also unclear to what extent these aging-associated motor- cognitive changes may be affected by VR rehab games and whether systemic- and neuro-inflammation is ameliorated by this novel intervention in older adults. This purpose of this study is to design and implement a Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes (V-TARGET) intervention, focusing on adults (aged up to 75 years old). The study will compare the effects of V-TARGET intervention (self-paced treadmill-simulator exercise with VR rehab games) against a control group on motor-cognitive function, health-related quality of life (HRQOL), circulating inflammatory markers and cerebral/peripheral blood flow through this 5-week intervention (2 times/week, 30-minutes/session, 10 sessions total).

Conditions

Adult ALL

Keywords

Virtual-Reality; Fall Risk Invention; Physical Activity; Neuromotor Rehabilitation

Outcome Measures

Primary Outcomes (4)

• Motor Function

  The Tinetti scale measures motor function; the total score ranges from 0- 28: a total score of less than or equal to 18 indicates high risk of falling; score range 19-23 indicates moderate risk of falling; and more than or equal to 24 indicates low risk of falling.

  Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.

• Motor skill

  The Bruininks Motor Ability Test (BMAT) is a standardized test of gross and fine motor skills for adults and older. It assesses fine motor integration, manual dexterity, coordination, balance and mobility, and strength and flexibility. Each subtest score is converted into scaled scores based on normative data. The total BMAT score is derived by summing the scores from each domain, which can then be compared to age-based norms. Higher scores indicate better motor abilities, while lower scores may suggest areas that could benefit from intervention or support.

  Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.

• Cognitive function: Multitasking test (MTT)

  Cognitive function is assessed with CANTAB (Cambridge Neuropsychological Test Automated Battery) using a handheld tablet (10 x 10-inch iPad). Multitasking test (MTT) is a test of the participant's ability to manage conflicting information provided by the direction of an arrow and its location on the screen and to ignore task-irrelevant information. Outcome measures include response latencies and error scores.

  Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.

• Cognitive function: The spatial working memory (SWM) test

  Cognitive function is assessed with CANTAB (Cambridge Neuropsychological Test Automated Battery) using a handheld tablet (10 x 10-inch iPad). The spatial working memory (SWM) test requires retention and manipulation of visuospatial information, and provides a measure of strategy as well as working memory errors. Outcome measures include errors and strategies.

  Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.

Secondary Outcomes (10)

• Circulating inflammatory markers: percentage of T cells expressing CXCR3

  Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.

• Circulating inflammatory markers: interferon-gamma (IFN-γ)

  Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.

• Circulating inflammatory markers: Circulating CXCL10

  Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.

• Cerebrovascular Health: Heart Rate

  Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.

• Cerebrovascular Health: Systolic arterial blood pressure in the brachial artery (mmHg)

  Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.

Study Arms (2)

V-TARGET intervention group

EXPERIMENTAL

All participants in the V-TARGET intervention group will exercise on the Virtuix Omni 360-degree self-paced, non-powered treadmill-simulator in the lab for 5-weeks (2 days/week, 30 minutes/session, 10 sessions total. The treadmill-simulator is a first-of-its-kind motion platform on which an individual can walk and run at a self-paced speed in 360 degrees (i.e., forwards, sideways and backwards) without risk of falling or colliding with other people. The V-TARGET intervention group will self-pace their locomotor action (walking/running) on the Omni treadmill-simulator while they wear the Pico Neo 2 head-mounted display (HMD) headset and use the Neuro Rehab VR XR Therapy system to experience daily activity exercises/games, including Retail Therapy, Explore (gait training), Lunchtime Adventure, and Nature Walk.

Device: V-TARGET intervention

The waitlist control group

NO INTERVENTION

The control group will not do any VR exercise but will only complete the pre-post and 1-month follow-up assessment upon signing up the study.

Interventions

V-TARGET intervention DEVICE

V-TARGET intervention will be delivered through a 360 degree self-paced treadmill in a university clinical laboratory for 5-weeks (2 days/week, 30 minutes/session) with total 10 sessions. The treadmill is the first-of-kind motion platform that an individual can walk and run at self-paced speed in 360 degree (i.e., forwards, sideways and backwards) without risk of falling or colliding with other people. During the V-TARGET intervention, participants will self-pace their locomotor action (walking/running) while they wear the HTC vivo headset and experience daily exercises/games augmented by the VR Therapy System. Therapy System is a library of VR exercises/games targeted on neurological rehabilitation, balance improvement training as well as cognitive therapy suited for variety of conditions, and includes various daily living simulation activities such as Retail Shopping, Gait Training, Cafeteria Experience, and Nature Walk.

V-TARGET intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: This study is open to participants of all genders, including individuals who self-identify as male, female, non-binary, genderqueer, or any other gender identity. Individuals who self-identify as transgender or cisgender are welcomes. If participants' gender identity does not fit within traditional male or female categories, participation of the study is still welcomed.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults aged up to 75 years old
• able to walk independently, without use of an assistive device
• English speaking

You may not qualify if:

• self-disclosed limited mobility in joint(s) due to arthritis or other condition that would prevent participation
• any ongoing orthopedic injury
• cardiac surgery or any ongoing cardiovascular issues preventing participation or physical activity.
• motor/cognitive disorders (Alzheimer's disease, Parkinson's disease, dementia, etc.)
• use of a wheelchair

Sponsors & Collaborators

• The University of Texas at Arlington: lead

Study Sites (1)

University of Texas at Arlington Movement & Physical Activity Epidemiology Laboratory

Arlington, Texas, 76019, United States

RECRUITING

Related Links

• Virtual Reality Rehab-Therapy on Neuromotor Function and Cardiovascular Health

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Motor Activity

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Behavior

Study Officials

• Xiangli Gu

  University of Texas at Arlington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Associate Professor

CONTACT

817-272-3318; xiangli.gu@uta.edu

Professor

CONTACT

817-272-3156; matthew.brothers@uta.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized into two groups: the intervention group and the control group. All participants will exercise on the Virtuix Omni 360-degree self-paced, non-powered treadmill-simulator in the lab for 5-weeks (2 days/week, 30 minutes/session, 10 sessions total. The treadmill-simulator is a first-of-its-kind motion platform on which an individual can walk and run at a self-paced speed in 360 degrees without risk of falling or colliding with other people. The V-TARGET intervention group will self-pace their locomotor action (walking/running) on the Omni treadmill-simulator while they wear the Pico Neo 2 head-mounted display (HMD) headset and use the Neuro Rehab VR XR Therapy system to experience daily activity exercises/games, including Retail Therapy, Explore (gait training), Lunchtime Adventure, and Nature Walk. The control group will not do any VR exercise but will only complete the pre-post and 1-month follow-up assessment upon signing up the study.

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: December 11, 2024
• Study Start: May 10, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)