Impact of Footwear on Gait in Unilateral Transtibial Amputees

Официальное название

The Impact of Footwear on Gait in Unilateral Transtibial Amputees

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Own Footwear
  Participants wear their own regularly used footwear while completing gait and standing assessments in a motion analysis laboratory.
• Устройство Oxford Shoe
  Participants wear a standard Oxford shoe while completing gait and standing assessments in a motion analysis laboratory.
• Устройство Walking/Running Shoe
  Participants wear a walking/running shoe while completing gait and standing assessments in a motion analysis laboratory.
• Устройство Rocker Shoe
  Participants wear a rocker shoe while completing gait and standing assessments in a motion analysis laboratory.

Первичные конечные точки

• Gait speed [Срок оценки: Baseline (single laboratory assessment)]
• Stride length [Срок оценки: Baseline (single laboratory assessment)]
• Cadence [Срок оценки: Baseline (single laboratory assessment)]
• Prosthetic foot clearance during swing phase [Срок оценки: Baseline (single laboratory assessment)]
• Foot clearance time [Срок оценки: Baseline (single laboratory assessment)]
• Ground reaction forces [Срок оценки: Baseline (single laboratory assessment)]
• Stance phase duration [Срок оценки: Baseline (single laboratory assessment)]
• Ankle power generated by the prosthetic foot [Срок оценки: Baseline (single laboratory assessment)]

Вторичные конечные точки (2)

• Perceived footwear comfort [Срок оценки: Immediately after each footwear condition during the baseline laboratory assessment.]
• Perceived footwear stability [Срок оценки: Immediately after each footwear condition during the baseline laboratory assessment.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Великобритания · 1 центр

• University of Salford — Manchester

Идентификаторы

NCT: NCT07685496 · 365897

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗