Investigating the Impact of Treadmill-integrated Virtual Reality Training on Walking Outside the Clinic

Investigating the Acute and Long-term Effects of Treadmill-integrated Virtual Reality (VR) Training on Real-World Mobility and Fall-Related Outcomes in People With Multiple Sclerosis

This study will test whether a treadmill-based virtual reality walking program is safe, practical, and helpful for people with multiple sclerosis (MS). Participants will complete a 6-week training program and wear smart socks that measure how they walk before, during, and after the program. The study will also track changes in balance, fatigue, fall risk, fear of falling, confidence with walking, and overall quality of life.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Treadmill-integrated virtual reality gait training

Detailed Description

People with multiple sclerosis (MS) often have trouble with walking and balance, which can increase the risk of falls and make daily life harder. While therapy can improve walking in a clinic, it is not always clear if those improvements carry over to real life at home or in the community. In addition, most walking tests are done over short periods and may not show how a person moves throughout the day. This study will look at new ways to better understand and improve walking in everyday settings. Researchers will use a treadmill-based virtual reality program, along with smart socks that track walking during daily activities. This approach will help show how people respond to training and whether those changes last outside the clinic. Standard care for people with MS usually includes physical therapy and clinic-based walking tests, but these may miss important changes in daily movement.

Participants will be asked to provide basic health information and complete surveys about their walking, fatigue, balance, thinking, and quality of life at different times during the study. They will also complete simple walking and balance tests to measure their mobility. As part of the study, participants will take part in a 6-week treadmill-based virtual reality training program, with two sessions each week. During the study, they will wear smart socks that collect information about how they walk in their daily lives, including before, during, and after the training program. These socks will track how often they walk, how steady they are, and how their walking changes over time. After the training ends, participants will continue wearing the socks for several weeks so researchers can see if improvements last. The results will help researchers learn if this approach can improve walking, lower fall risk, and support better mobility and quality of life for people living with MS.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie F Stowell, DPT; Phone Number: 4046035049; Email: julie.stowell@shepherd.org

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Recruiting
      • Shepherd Center
      • Contact: Julie F Stowell, DPT; Phone Number: 404-603-5049; Email: julie.stowell@shepherd.org
      • Principal Investigator: Julie F Stowell, DPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have a clinically confirmed diagnosis of multiple sclerosis (MS).
• Be 18 years of age or older.
• Demonstrate ≥10% variability in stride length, step length, or gait asymmetry.
• Can ambulate without an assistive device, with a unilateral, or with a bilateral assistive device.
• Demonstrate no more than mild cognitive impairment, indicated by the Mini-Mental State Exam (score >19).
• Possess adequate cognitive function to understand and follow research instructions.
• Be able to safely participate in the study and training procedures as determined by study staff.
• Be fluent in English and able to communicate discomfort, fatigue, or pain in English.
• Be able to travel to Shepherd Center to complete key assessment points in-person and for in-person training sessions twice per week.

Exclusion Criteria:

• Have a diagnosis of any other neurological condition or recent orthopedic conditions that affects gait, balance, or mobility.
• Exhibit <10% variability in stride length, step length, or gait asymmetry.
• Are unable to ambulate (i.e. wheelchair bound or bedbound individuals).
• Have legal blindness or severe visual impairment that would interfere with virtual reality engagement or safe ambulation.
• Have a body weight exceeding 300 lbs., which exceeds the safety limits of the treadmill and body weight support system.
• Have uncontrolled or untreated hypertension, hypotension, or angina.
• Have a past or current history of epilepsy or any other type of seizure disorder, whether controlled or uncontrolled.
• Have undergone major surgery within the past 6 months or hospitalization within the past 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Gait training	Other: Treadmill-integrated virtual reality gait training; 6-week training program with 2 training sessions each week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spatiotemporal metrics of gait	step length (m)	Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait	stride length (m)	Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait	step time (s)	Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait	single support time (s)	Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait	double support time (s)	Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait	gait cycle (s)	Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait	cadence (steps/s)	Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait	stance time (s)	Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait	speed(m/s)	Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait	swing time (s)	Initial visit to the end of the program in 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear of falling (FOF)	FOF as determined by Falls Efficacy Scale-International (FES-I); Scale: Not at all concerned = 1, Somewhat concerned = 2, Fairly concerned = 3, Very concerned = 4; Lowest score = 16, Highest score = 64, lower scores indicated less FOF (better), higher scores indicated more FOF (worse), total score divided by 64.	Surveys will be conducted at the initial visit, week 2, 5, 8, and 12.

Collaborators and Investigators

• Sponsor: Shepherd Center, Atlanta GA

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2026
• Primary Completion (Estimated): April 27, 2027
• Study Completion (Estimated): April 27, 2027

Study Registration Dates

• First Submitted: November 2, 2026
• First Submitted That Met QC Criteria: November 9, 2026
• First Posted (Actual): November 10, 2026

Study Record Updates

• Last Update Posted (Actual): November 10, 2026
• Last Update Submitted That Met QC Criteria: November 9, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: gait; walking; virtual reality; balance; fear of falling; treadmill training; spatiotemporal metrics
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: 1111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Shepherd Center will publish findings as appropriate and will maintain confidential records as necessary.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No