Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

9 november 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

10

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30309
        • Rekrytering
        • Shepherd Center
        • Kontakt:
        • Huvudutredare:
          • Julie F Stowell, DPT

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Arm 1

Gait training

6-week training program with 2 training sessions each week

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Spatiotemporal metrics of gait
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Fear of falling (FOF)
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

31 juli 2026

Primärt slutförande (Beräknad)

27 april 2027

Avslutad studie (Beräknad)

27 april 2027

Studieregistreringsdatum

Först inskickad

2 november 2026

Först inskickad som uppfyllde QC-kriterierna

9 november 2026

Första postat (Faktisk)

10 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera