Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07685496

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Salford

Manchester, Greate Manchester, M6 6PU, United Kingdom

Location contact

Abdulaziz Alkanderi, PhD Candidate

CONTACT

[email protected]

+447443673361

Richard Jones, Professor

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Own Footwear

Device

Participants wear their own regularly used footwear while completing gait and standing assessments in a motion analysis laboratory.

Oxford Shoe

Device

Participants wear a standard Oxford shoe while completing gait and standing assessments in a motion analysis laboratory.

Walking/Running Shoe

Device

Participants wear a walking/running shoe while completing gait and standing assessments in a motion analysis laboratory.

Rocker Shoe

Device

Participants wear a rocker shoe while completing gait and standing assessments in a motion analysis laboratory.

Primary outcomes

  1. Gait speed

    Time frame: Baseline (single laboratory assessment)

    Gait speed measured using three-dimensional motion capture and force plate analysis during walking under each footwear condition.

  2. Stride length

    Time frame: Baseline (single laboratory assessment)

    Stride length measured using three-dimensional motion capture during walking under each footwear condition.

  3. Cadence

    Time frame: Baseline (single laboratory assessment)

    Cadence measured using three-dimensional motion capture during walking under each footwear condition.

  4. Prosthetic foot clearance during swing phase

    Time frame: Baseline (single laboratory assessment)

    Prosthetic foot clearance during swing phase measured using three-dimensional motion capture under each footwear condition.

  5. Foot clearance time

    Time frame: Baseline (single laboratory assessment)

    Foot clearance time measured using three-dimensional motion capture under each footwear condition.

  6. Ground reaction forces

    Time frame: Baseline (single laboratory assessment)

    Ground reaction forces measured using force plate analysis during walking under each footwear condition.

  7. Stance phase duration

    Time frame: Baseline (single laboratory assessment)

    Stance phase duration measured using three-dimensional motion capture and force plate analysis under each footwear condition.

  8. Ankle power generated by the prosthetic foot

    Time frame: 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.

Secondary outcomes

  1. Perceived footwear comfort

    Time frame: Immediately after each footwear condition during the baseline laboratory assessment.

    Participant-rated comfort for each footwear condition using a 100 mm Visual Analogue Scale (VAS), anchored from "Extremely Uncomfortable" to "Extremely Comfortable".

  2. Perceived footwear stability

    Time frame: Immediately after each footwear condition during the baseline laboratory assessment.

    Participant-rated stability for each footwear condition using a 100 mm Visual Analogue Scale (VAS), anchored from "Very Unstable" to "Very Stable".

Study contacts

Contact information is provided by the study sponsor or research team.

Abdulaziz Alkanderi, PhD Candidate

CONTACT

[email protected]

+447443673361

Sponsors and collaborators

Lead sponsor

University of Salford

Other

Registry information

Official study title

The Impact of Footwear on Gait in Unilateral Transtibial Amputees

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.