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Long-Term Effects of Torso-Weighting (TWPS)

9 de octubre de 2018 actualizado por: San Francisco State University

Long-Term Effects of Balance-Based Torso-Weighting: Pilot Study

The goal of this pilot study is to test the protocol for investigating the longer-term effects of torso weighting on physical activity, number of falls, and muscle activation (when muscles turn on and off and how intensely) in five volunteers with multiple sclerosis. The hypotheses of this study include: torso weighting will (1) increase physical activity, (2) decrease the number of falls, and (3) improve the timing and coordination of muscle activation during balance perturbations.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Torso weighting, using the balance-based torso-weighting (BBTW) method, is an intervention that addresses balance by first challenging stability in standing using a series of perturbations (nudges) and resisted rotations to people. Challenging stability allows the assessor to determine directional instability. Once the direction of instability is determined, small weights are placed on a vest-like garment and retesting of balance occurs. In this study, participants will be tested with no weights (NW), with sham weights (SW), and with BBTW weighting (WT). Following non-weighted baseline assessment, participants will be randomly allocated into the sham weight condition or BBTW weight condition in a cross-over design. The initial condition (NW) will last four weeks and the final two conditions (SW,WT) will last two weeks each. Following each condition, outcome measures will be reassessed. Throughout the study, participants will be asked to wear a commercially-available remote monitoring device (e.g., Fitbit Flex) and keep a daily log of physical activity and number of falls. During the SW and WT conditions, participants will wear the assigned garment for 2-4 hours daily.

Tipo de estudio

Intervencionista

Inscripción (Actual)

5

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.

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Oakland, California, Estados Unidos, 94609
        • Samuel Merritt University, Motion Analysis Research Center

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:

  • Self-reported a diagnosis of multiple sclerosis
  • Self-reported mild or moderate gait or balance difficulties
  • Living in the community rather than in a care facility
  • Able to walk independently for at least one minute at a time with or without an assistive device
  • No exacerbations within the past 2 months
  • Able to get to the testing area and tolerate 2-3 hours of testing for each assessment occasion
  • Willing to be nudged by a researcher when standing

Exclusion Criteria:

  • Unable to comprehend and follow instructions in English
  • Current diagnosis of other neurological disorders such as head injury, stroke, Parkinson disease, or other conditions that affect gait or balance (self-reported)
  • Experiencing pain that could be exacerbated by external perturbation while standing
  • History of skin reaction to adhesives

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: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Torso Weights then Sham Weights

No weights worn for 4 weeks. Garment with torso weights worn 2-4 hours daily for 2 weeks. Then participants cross-over to wear garment with sham weights for 2-4 hours daily for 2 weeks.

Participants wear the Fitbit Flex throughout.
Dispositivo: Torso Weights
Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
Otros nombres:
  • WT
Dispositivo: Sham Weights
Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss. The garment is then taken by another investigator and the actual weights are replaced with sham weights.
Otros nombres:
  • SUDOESTE
Dispositivo: Fitbit Flex
Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.
Otros nombres:
  • remote activity monitoring device
Experimental: Sham Weights then Torso Weights

No weights worn for 4 weeks. Garment with sham weights worn 2-4 hours daily for 2 weeks. Then participants cross-over to wear garment with torso weights for 2-4 hours daily for 2 weeks.

Participants wear the Fitbit Flex throughout.
Dispositivo: Torso Weights
Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
Otros nombres:
  • WT
Dispositivo: Sham Weights
Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss. The garment is then taken by another investigator and the actual weights are replaced with sham weights.
Otros nombres:
  • SUDOESTE
Dispositivo: Fitbit Flex
Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.
Otros nombres:
  • remote activity monitoring device

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Steps Per Day
Periodo de tiempo: up to 8 weeks
Continuous activity data collection via commercially-available remote monitoring device and stored on server.
up to 8 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Sensory Organization Test
Periodo de tiempo: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
balance tested during 6 conditions on Neuro-com forceplate and surround and reported as a composite score (across the six conditions), 0-100, with higher scores indicating better balance; measure reported reflects change in the composite score from the visit that initiates Torso-weighting (TW) or sham weights (SW) to the visit that concludes daily wearing of TW or SW
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Gait Velocity
Periodo de tiempo: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
As measured using instrumented gait mat.
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Movement Ability Measure, Computer Adaptive Test Version (MAM-CAT)
Periodo de tiempo: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Online self-report of perceived current movement ability and preferred movement ability. The scores are reported in standardized logits, 0-6, where 6 is competitive level athletic movement. The reported values are the average change in current movement ability from initiation of daily wear to after 2 weeks of daily wear of TW or SW.
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Activities-Specific Balance Confidence Scale
Periodo de tiempo: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Self-report measure of perception of confidence under various balance challenges on a scale of 0-100 with 100 being fully confident that the individual can perform the listed balance challenge without falling. Data reported reflect the difference in scores from initiation to the 2-week point after initiation of TW or SW.
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Multiple Sclerosis Impact Scale 29
Periodo de tiempo: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Self-report measure of the impact of MS on activities and participation. The scale is reported in a physical and psychological subscale, with higher numbers (out of 100) indicating worse impact of multiple sclerosis (MS) on function. Data are reported as change from initiation of TW or SW to end of 2 weeks of daily wear.
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Multiple Sclerosis Walking Scale 12
Periodo de tiempo: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Self-report measure of the effect of MS on walking ability. Larger numbers out of 100 mean that MS limits walking much more. Data are reported as change in score from initiation of TW or SW to the visit after 2 weeks of daily wear of TW or SW.
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Six-Minute Walk Test
Periodo de tiempo: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
distance participant walks in 6 minutes. Larger numbers indicate more distance covered. Data reported are the change in distance walked from initiation of TW or SW to after 2 weeks of daily wear.
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Stride Length
Periodo de tiempo: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
As measured using instrumented gait mat.
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Percent of Gait Cycle in Single Limb Support
Periodo de tiempo: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
As measured in percent (e.g., 0.35) of gait cycle spent on one limb using instrumented gait mat.
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Step Width
Periodo de tiempo: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
As measured using instrumented gait mat.
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Electromyography to Assess Muscle Activation
Periodo de tiempo: Week 4, Week 6, Week 8
Recording of muscle activation during quiet and perturbed standing before and after intervention at weeks 4, 6, and 8. Average values with and without weighting during each visit.
Week 4, Week 6, Week 8
Number of Falls Recorded in 2 Weeks of Wear Time.
Periodo de tiempo: count of number of falls recorded at the end of two weeks of wearing TW or SW
Daily log manually recorded by participant for the 2 weeks of wear time. This is a descriptive measure recording the total count (number) of falls per arm.
count of number of falls recorded at the end of two weeks of wearing TW or SW

Colaboradores e Investigadores

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

Patrocinador

San Francisco State University

Colaboradores

Samuel Merritt University

Investigadores

  • Investigador principal: Diane Allen, PhD, San Francisco State University

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

1 de noviembre de 2015

Finalización primaria (Actual)

1 de mayo de 2016

Finalización del estudio (Actual)

1 de junio de 2016

Fechas de registro del estudio

Enviado por primera vez

7 de octubre de 2015

Primero enviado que cumplió con los criterios de control de calidad

18 de abril de 2016

Publicado por primera vez (Estimar)

19 de abril de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de noviembre de 2018

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

9 de octubre de 2018

Última verificación

1 de octubre de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • X15-48a

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. .

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