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

9 de noviembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

10

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30309
        • Reclutamiento
        • Shepherd Center
        • Contacto:
        • Investigador principal:
          • Julie F Stowell, DPT

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Arm 1

Gait training

6-week training program with 2 training sessions each week

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Spatiotemporal metrics of gait
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Fear of falling (FOF)
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

31 de julio de 2026

Finalización primaria (Estimado)

27 de abril de 2027

Finalización del estudio (Estimado)

27 de abril de 2027

Fechas de registro del estudio

Enviado por primera vez

2 de noviembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de noviembre de 2026

Publicado por primera vez (Actual)

10 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 1111

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .