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A Comparison Between Ischial-Containment and Sub-Ischial Prosthetic Sockets to Determine Their Effects on Secondary Health Conditions

12 de agosto de 2026 actualizado por: VA Office of Research and Development
Long-term above-knee prosthesis users are at an increased risk of developing secondary musculoskeletal conditions compared to the general able-bodied population. One secondary physical concern is low back pain (LBP), for which the development is not entirely understood, but in above-knee prosthesis users it is believed to relate to asymmetries and compensations that are typically demonstrated and required to stand and walk. Understanding spinal motion and compensations will enhance our knowledge of the factors contributing to LBP, and possibly lead to the development of new prosthetic and therapeutic interventions to prevent or alleviate LBP, thereby improving mobility and quality of life for prosthesis users.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Descripción detallada

The purpose of this study is to investigate and compare the effects of the standard ischial containment (IC) socket to a sub-ischial (SI) socket design on the spinal and pelvic motions and leg length (LLD) discrepancies of transfemoral prosthesis users. Data will be collected from 2 groups of transfemoral prosthesis users (15 SI socket wearers and 15 IC socket wearers) and a group of 15 able-bodied (AB) control participants. Gait and standing analyses will be conducted on each participant using a marker based motion capture system. Prosthesis users will wear their own conventional sockets for the gait and standing analyses. Kinematic and kinetic data will be analyzed for differences between the 2 groups of socket wearers and will also be compared to the control group.

The specific aims and hypotheses of this project are:

Aim 1: To measure dynamic leg length and kinematics of the pelvis and spinal segments in unilateral, transfemoral prosthesis users during gait. Quantitative motion analyses will be performed on two groups of 15 research participants with lower limb amputation using 2 different socket designs (IC and SI) walking over level ground at three self-selected walking speeds (normal, moderately fast, fastest). Data will be compared between socket type and to an AB control group. Hypothesis 1a-IC socket wearers will have a greater anterior pelvic tilt compared to SI socket wearers and AB controls, and they will exhibit considerably greater rotations of the pelvis and spinal segments during walking. Hypothesis 1b-The EMG activity of the lumbar erector spinae for SI socket users will better approximate the patterns of AB controls as compared to IC socket wearers. Hypothesis 1c-The dynamic LLD will be greater for IC socket users compared to SI socket wearers and AB controls.

Aim 2: To measure pelvic orientation and static leg length in unilateral, transfemoral prosthesis users during standing. A multi-segment model of the spine and pelvis will be used to determine neutral spinal, pelvis, and prosthetic alignment during standing for the research and AB control participants. Hypothesis 2a-IC socket wearers will demonstrate greater anterior pelvic tilt during standing compared to SI socket wearers and control participants. Hypothesis 2b-The prosthetic and sound leg lengths for both prosthesis user groups will be within 1.0 cm of each other during standing.

Aim 3: To estimate joint contact forces in the legs and lower back of unilateral, transfemoral prosthesis users and controls during gait. Computational musculoskeletal simulations will be used to comprehensively evaluate the data from Aim 1 to compare the lumbar joint loads between IC and SI socket wearers. Hypothesis 3-IC socket wearers will exhibit greater lumbar joint loads than SI socket wearers.

Tipo de estudio

De observación

Inscripción (Estimado)

45

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

  • Nombre: Rebecca Stine, MS
  • Número de teléfono: (312) 503-5726
  • Correo electrónico: rebecca.stine@va.gov

Copia de seguridad de contactos de estudio

  • Nombre: Steven A Gard, PhD
  • Número de teléfono: (312) 503-5718
  • Correo electrónico: steven.gard@va.gov

Ubicaciones de estudio

  • Estados Unidos
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60612
        • Jesse Brown VA Medical Center, Chicago, IL
        • Contacto:
        • Contacto:
          • Steven A Gard, PhD
          • Número de teléfono: (312) 503-5718
          • Correo electrónico: steven.gard@va.gov
        • Investigador principal:
          • Rebecca Stine, MS

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

Thirty unilateral transfemoral prosthesis users (15 with an ischial containment socket and 15 with a sub-ischial socket) and 15 able-bodied control participants.

Descripción

Inclusion Criteria:

For all participants:

  • Ability to complete the experimental protocol without undue fatigue or health risks
  • Low Back Pain scale assessment (0-10) less than 4 (activities of daily living or quality of life not impacted)

In addition for persons with lower limb amputation:

  • Prosthesis user for a minimum of 2 years with their current socket design
  • Good fit with either an ischial containment (IC) or sub-ischial (SI) socket
  • Good skin integrity on their residual limb upon visual inspection
  • Does not require the use of assistive devices to walk

Exclusion Criteria:

  • Previously diagnosed with a spine condition (e.g., pinched nerve, bulging disc, etc.)
  • Previously diagnosed with an orthopedic or neuromuscular condition that may affect walking or balance (e.g., ankle fusion, Parkinson's disease, stroke, etc.)

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

Cohortes e Intervenciones

Grupo / Cohorte
Ischial Containment Socket user
Person with unilateral transfemoral amputation wearing an ischial containment socket
Sub-Ischial Socket user
Person with unilateral transfemoral amputation wearing a sub-ischial socket
Able-bodied control
Person without an amputation

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Anterior Pelvic Tilt Angle Between the IC Socket wearers and the SI Socket wearers/Able-Bodied Controls
Periodo de tiempo: To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Anterior Pelvic Tilt will be calculated for all participants during the walking and standing trials. Participants will walk along a 10 meter walkway at varying speeds. Quantitative motion analysis using a marker based motion measurement system will be used to calculate anterior pelvic tilt.
To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Electromyography (EMG) Activity of the Lumbar Erector Spinae Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
Periodo de tiempo: To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
EMG activity will be assessed using surface electrodes attached bilaterally to the erector spinae at and below T12/L1 and on the external oblique muscle. Data will be collected during the quantitative motion analysis.
To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Lumbar Flexion Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
Periodo de tiempo: To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Lumbar flexion will be calculated for all participants during the walking and standing trials. Participants will walk along a 10 meter walkway at varying speeds. Quantitative motion analysis using a marker based motion measurement system will be used to calculate anterior pelvic tilt.
To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Hip Joint Range of Motion (ROM) between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
Periodo de tiempo: To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Hip Joint ROM will be calculated for all participants during the walking trials. Participants will walk along a 10 meter walkway at varying speeds. Quantitative motion analysis using a marker based motion measurement system will be used to calculate hip joint ROM.
To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Dynamic Leg Length Discrepancy (LLD) Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
Periodo de tiempo: To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Dynamic LLD will be calculated for all participants during the walking trials. Participants will walk along a 10 meter walkway at varying speeds. Quantitative motion analysis using a marker based motion measurement system will be used to calculated dynamic LLD.
To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Peak Lumbar Joint Loading Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
Periodo de tiempo: To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Lumbar joint loading during walking will be analyzed by performing musculoskeletal modeling simulations using data collected during the quantitative motion analysis.
To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe

Colaboradores e Investigadores

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

Patrocinador

VA Office of Research and Development

Investigadores

  • Investigador principal: Rebecca Stine, MS, Jesse Brown VA Medical Center, Chicago, IL

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 (Estimado)

1 de enero de 2027

Finalización primaria (Estimado)

1 de julio de 2030

Finalización del estudio (Estimado)

31 de diciembre de 2030

Fechas de registro del estudio

Enviado por primera vez

4 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

12 de agosto de 2026

Publicado por primera vez (Actual)

17 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de agosto de 2026

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

12 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • RRD2-014-25W

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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

producto fabricado y exportado desde los 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. .

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