The Impact of Footwear on Gait in Unilateral Transtibial Amputees
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Gait speed
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Oxford Shoe
Participants complete walking and balance assessments while wearing a standard Oxford shoe.
干预措施: Oxford Shoe (Device)
Own Footwear
Participants complete walking and balance assessments while wearing their own regularly used footwear.
干预措施: Own Footwear (Device)
Walking/Running Shoe
Participants complete walking and balance assessments while wearing a walking/running shoe.
干预措施: Walking/Running Shoe (Device)
Rocker Shoe
Participants complete walking and balance assessments while wearing a rocker shoe.
干预措施: Rocker Shoe (Device)
结局指标
主要结局
Gait speed
时间窗: Baseline (single laboratory assessment)
Gait speed measured using three-dimensional motion capture and force plate analysis during walking under each footwear condition.
Stride length
时间窗: Baseline (single laboratory assessment)
Stride length measured using three-dimensional motion capture during walking under each footwear condition.
Cadence
时间窗: Baseline (single laboratory assessment)
Cadence measured using three-dimensional motion capture during walking under each footwear condition.
Prosthetic foot clearance during swing phase
时间窗: Baseline (single laboratory assessment)
Prosthetic foot clearance during swing phase measured using three-dimensional motion capture under each footwear condition.
Foot clearance time
时间窗: Baseline (single laboratory assessment)
Foot clearance time measured using three-dimensional motion capture under each footwear condition.
Ground reaction forces
时间窗: Baseline (single laboratory assessment)
Ground reaction forces measured using force plate analysis during walking under each footwear condition.
Stance phase duration
时间窗: Baseline (single laboratory assessment)
Stance phase duration measured using three-dimensional motion capture and force plate analysis under each footwear condition.
Ankle power generated by the prosthetic foot
时间窗: Baseline (single laboratory assessment)
Ankle power generated by the prosthetic foot measured using three-dimensional motion capture and force plate analysis during walking under each footwear condition.
次要结局
- Perceived footwear comfort(Immediately after each footwear condition during the baseline laboratory assessment.)
- Perceived footwear stability(Immediately after each footwear condition during the baseline laboratory assessment.)