RecruitingNCT07927439ClinicalTrials.gov record

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

Multiple Sclerosis

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Not applicable
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 10 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not applicable
Masking: No masking

Arm 1

Gait training

Other: Treadmill-integrated virtual reality gait training

Treadmill-integrated virtual reality gait training OTHER

6-week training program with 2 training sessions each week

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