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.
Обзор исследования
Статус
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Abdulaziz Alkanderi, PhD Candidate
- Номер телефона: +447443673361
- Электронная почта: a.alkanderi1@edu.salford.ac.uk
Места учебы
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Greate Manchester
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Manchester, Greate Manchester, Соединенное Королевство, M6 6PU
- Рекрутинг
- University of Salford
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Контакт:
- Abdulaziz Alkanderi, PhD Candidate
- Номер телефона: +447443673361
- Электронная почта: a.alkanderi1@edu.salford.ac.uk
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Главный следователь:
- Richard Jones, Professor
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: 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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Экспериментальный: 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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Экспериментальный: 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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Экспериментальный: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Gait speed
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Perceived footwear comfort
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 365897
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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