Impact of Footwear on Gait in Unilateral Transtibial Amputees

Official title

The Impact of Footwear on Gait in Unilateral Transtibial Amputees

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (2)

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Basic science

Study locations

United Kingdom · 1 center

• University of Salford — Manchester

Identifiers

NCT: NCT07685496 · 365897

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗