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

9. november 2026 opdateret af: Shepherd Center, Atlanta GA

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.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30309
        • Rekruttering
        • Shepherd Center
        • Kontakt:
        • Ledende efterforsker:
          • Julie F Stowell, DPT

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm 1

Gait training

6-week training program with 2 training sessions each week

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Spatiotemporal metrics of gait
Tidsramme: Initial visit to the end of the program in 12 weeks

step length (m)

Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait
Tidsramme: Initial visit to the end of the program in 12 weeks

stride length (m)

Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait
Tidsramme: Initial visit to the end of the program in 12 weeks

step time (s)

Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait
Tidsramme: Initial visit to the end of the program in 12 weeks

single support time (s)

Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait
Tidsramme: Initial visit to the end of the program in 12 weeks

double support time (s)

Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait
Tidsramme: Initial visit to the end of the program in 12 weeks

gait cycle (s)

Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait
Tidsramme: Initial visit to the end of the program in 12 weeks

cadence (steps/s)

Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait
Tidsramme: Initial visit to the end of the program in 12 weeks

stance time (s)

Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait
Tidsramme: Initial visit to the end of the program in 12 weeks

speed(m/s)

Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait
Tidsramme: Initial visit to the end of the program in 12 weeks

swing time (s)

Initial visit to the end of the program in 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fear of falling (FOF)
Tidsramme: Surveys will be conducted at the initial visit, week 2, 5, 8, and 12.

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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

31. juli 2026

Primær færdiggørelse (Anslået)

27. april 2027

Studieafslutning (Anslået)

27. april 2027

Datoer for studieregistrering

Først indsendt

2. november 2026

Først indsendt, der opfyldte QC-kriterier

9. november 2026

Først opslået (Faktiske)

10. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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