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Impact of Footwear on Gait in Unilateral Transtibial Amputees

NCT07685496 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-07-06

No results posted yet for this study

Summary

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.

Conditions

  • Transtibial Amputation
  • Lower Limb Amputation
  • Prosthesis 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.

Sponsors & Collaborators

  • University of Salford

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2026-12-15
Completion
2027-01-15

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07685496 on ClinicalTrials.gov