Impact of Footwear on Gait in Unilateral Transtibial Amputees
The Impact of Footwear on Gait in Unilateral Transtibial Amputees
The goal of this interventional study is to learn how different types of footwear affect gait, stability, comfort, and walking performance in adults with a unilateral transtibial amputation who use a lower limb prosthesis.
The main questions it aims to answer are:
- Does footwear type affect gait characteristics such as gait speed, stride length, cadence, prosthetic foot clearance, and stance phase duration?
- Does footwear type affect kinetic measures such as ground reaction forces and ankle power variables during walking?
- Does footwear type affect in-shoe plantar pressure distribution?
- Do participants perceive differences in comfort and stability between footwear conditions?
Participants will:
- Attend a laboratory-based gait analysis session at the University of Salford.
- Complete walking tasks while wearing four footwear conditions: their own preferred footwear, an Oxford shoe, a running/walking shoe, and a shoe with a forefoot rocker profile.
- Perform straight-line walking, incline and decline walking, and S-shaped walking tasks.
- Wear reflective markers and in-shoe pressure sensors during testing.
- Complete visual analogue scale ratings of comfort and stability for each footwear condition.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
People with transtibial amputations often rely on footwear that is comfortable, practical, and compatible with their prosthetic device. Although footwear is known to influence walking mechanics in the general population, there is limited evidence regarding its effects on gait in people who use lower limb prostheses. This study aims to investigate the impact of different footwear types on gait performance, stability, and comfort in adults with unilateral transtibial amputations.
Fifteen participants aged 18 to 65 years who use an energy-storing-and-return (ESAR) prosthetic foot will be recruited. Participants must be able to walk independently without a walking aid.
Each participant will attend a laboratory-based testing session at the University of Salford. Reflective markers will be placed on the body and prosthesis to allow three-dimensional motion analysis. Participants will also wear an in-shoe pressure measurement system.
Participants will complete a series of walking tasks while wearing four footwear conditions: their own preferred footwear, an Oxford shoe, a running/walking shoe, and a shoe with a forefoot rocker profile. The order of the footwear conditions will be randomised. Walking tasks will include straight-line walking, walking on an incline and decline, and walking along an S-shaped path involving turns.
Outcome measures will include gait speed, stride length, cadence, prosthetic foot clearance, stance phase duration, ground reaction forces, ankle power variables, and plantar pressure measurements. Participants will also rate the comfort and stability of each footwear condition using visual analogue scales and provide additional comments about their experience.
Data will be analysed to determine whether footwear type influences gait performance, stability, and perceived comfort in people with unilateral transtibial amputations. The findings may contribute to future clinical guidance and footwear recommendations for prosthetic users.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Abdulaziz Alkanderi, PhD Candidate
- Número de teléfono: +447443673361
- Correo electrónico: a.alkanderi1@edu.salford.ac.uk
Ubicaciones de estudio
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Greate Manchester
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Manchester, Greate Manchester, Reino Unido, M6 6PU
- Reclutamiento
- University of Salford
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Contacto:
- Abdulaziz Alkanderi, PhD Candidate
- Número de teléfono: +447443673361
- Correo electrónico: a.alkanderi1@edu.salford.ac.uk
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Investigador principal:
- Richard Jones, Professor
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Individuals with a unilateral transtibial amputation.
- Age 18 to 65 years.
- Participants must use an energy-storing and return (ESAR) prosthetic foot.
- Able to walk and stand without the use of walking aids.
- Absence of comorbidities known to impact balance and mobility.
Exclusion Criteria:
- Bilateral amputees or individuals with amputation levels other than transtibial.
- Individuals under 18 years or over 65 years of age.
- Use of any prosthetic foot type other than ESAR.
- Individuals unable to provide informed consent.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Own Footwear
Participants complete walking and balance assessments while wearing their own regularly used footwear.
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Participants wear their own regularly used footwear while completing gait and standing assessments in a motion analysis laboratory.
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Experimental: Oxford Shoe
Participants complete walking and balance assessments while wearing a standard Oxford shoe.
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Participants wear a standard Oxford shoe while completing gait and standing assessments in a motion analysis laboratory.
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Experimental: Walking/Running Shoe
Participants complete walking and balance assessments while wearing a walking/running shoe.
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Participants wear a walking/running shoe while completing gait and standing assessments in a motion analysis laboratory.
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Experimental: Rocker Shoe
Participants complete walking and balance assessments while wearing a rocker shoe.
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Participants wear a rocker shoe while completing gait and standing assessments in a motion analysis laboratory.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Gait speed
Periodo de tiempo: Baseline (single laboratory assessment)
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Gait speed measured using three-dimensional motion capture and force plate analysis during walking under each footwear condition.
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Baseline (single laboratory assessment)
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Stride length
Periodo de tiempo: Baseline (single laboratory assessment)
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Stride length measured using three-dimensional motion capture during walking under each footwear condition.
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Baseline (single laboratory assessment)
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Cadence
Periodo de tiempo: Baseline (single laboratory assessment)
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Cadence measured using three-dimensional motion capture during walking under each footwear condition.
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Baseline (single laboratory assessment)
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Prosthetic foot clearance during swing phase
Periodo de tiempo: Baseline (single laboratory assessment)
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Prosthetic foot clearance during swing phase measured using three-dimensional motion capture under each footwear condition.
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Baseline (single laboratory assessment)
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Foot clearance time
Periodo de tiempo: Baseline (single laboratory assessment)
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Foot clearance time measured using three-dimensional motion capture under each footwear condition.
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Baseline (single laboratory assessment)
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Ground reaction forces
Periodo de tiempo: Baseline (single laboratory assessment)
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Ground reaction forces measured using force plate analysis during walking under each footwear condition.
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Baseline (single laboratory assessment)
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Stance phase duration
Periodo de tiempo: Baseline (single laboratory assessment)
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Stance phase duration measured using three-dimensional motion capture and force plate analysis under each footwear condition.
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Baseline (single laboratory assessment)
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Ankle power generated by the prosthetic foot
Periodo de tiempo: Baseline (single laboratory assessment)
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Ankle power generated by the prosthetic foot measured using three-dimensional motion capture and force plate analysis during walking under each footwear condition.
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Baseline (single laboratory assessment)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Perceived footwear comfort
Periodo de tiempo: Immediately after each footwear condition during the baseline laboratory assessment.
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Participant-rated comfort for each footwear condition using a 100 mm Visual Analogue Scale (VAS), anchored from "Extremely Uncomfortable" to "Extremely Comfortable".
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Immediately after each footwear condition during the baseline laboratory assessment.
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Perceived footwear stability
Periodo de tiempo: Immediately after each footwear condition during the baseline laboratory assessment.
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Participant-rated stability for each footwear condition using a 100 mm Visual Analogue Scale (VAS), anchored from "Very Unstable" to "Very Stable".
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Immediately after each footwear condition during the baseline laboratory assessment.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 365897
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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