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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lower Limb Amputation; Transtibial Amputation; Prosthesis Users
• Intervention / Treatment: Device: Own Footwear; Device: Oxford Shoe; Device: Walking/Running Shoe; Device: Rocker Shoe

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdulaziz Alkanderi, PhD Candidate; Phone Number: +447443673361; Email: a.alkanderi1@edu.salford.ac.uk

Study Locations

• United Kingdom
  • Greate Manchester
    • Manchester, Greate Manchester, United Kingdom, M6 6PU
      • University of Salford
      • Contact: Abdulaziz Alkanderi, PhD Candidate; Phone Number: +447443673361; Email: a.alkanderi1@edu.salford.ac.uk
      • Principal Investigator: Richard Jones, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Own Footwear; Participants complete walking and balance assessments while wearing their own regularly used footwear.	Device: Own Footwear; Participants wear their own regularly used footwear while completing gait and standing assessments in a motion analysis laboratory.
Experimental: Oxford Shoe; Participants complete walking and balance assessments while wearing a standard Oxford shoe.	Device: Oxford Shoe; Participants wear a standard Oxford shoe while completing gait and standing assessments in a motion analysis laboratory.
Experimental: Walking/Running Shoe; Participants complete walking and balance assessments while wearing a walking/running shoe.	Device: Walking/Running Shoe; Participants wear a walking/running shoe while completing gait and standing assessments in a motion analysis laboratory.
Experimental: Rocker Shoe; Participants complete walking and balance assessments while wearing a rocker shoe.	Device: Rocker Shoe; Participants wear a rocker shoe while completing gait and standing assessments in a motion analysis laboratory.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait speed	Gait speed measured using three-dimensional motion capture and force plate analysis during walking under each footwear condition.	Baseline (single laboratory assessment)
Stride length	Stride length measured using three-dimensional motion capture during walking under each footwear condition.	Baseline (single laboratory assessment)
Cadence	Cadence measured using three-dimensional motion capture during walking under each footwear condition.	Baseline (single laboratory assessment)
Prosthetic foot clearance during swing phase	Prosthetic foot clearance during swing phase measured using three-dimensional motion capture under each footwear condition.	Baseline (single laboratory assessment)
Foot clearance time	Foot clearance time measured using three-dimensional motion capture under each footwear condition.	Baseline (single laboratory assessment)
Ground reaction forces	Ground reaction forces measured using force plate analysis during walking under each footwear condition.	Baseline (single laboratory assessment)
Stance phase duration	Stance phase duration measured using three-dimensional motion capture and force plate analysis under each footwear condition.	Baseline (single laboratory assessment)
Ankle power generated by the prosthetic foot	Ankle power generated by the prosthetic foot measured using three-dimensional motion capture and force plate analysis during walking under each footwear condition.	Baseline (single laboratory assessment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived footwear comfort	Participant-rated comfort for each footwear condition using a 100 mm Visual Analogue Scale (VAS), anchored from "Extremely Uncomfortable" to "Extremely Comfortable".	Immediately after each footwear condition during the baseline laboratory assessment.
Perceived footwear stability	Participant-rated stability for each footwear condition using a 100 mm Visual Analogue Scale (VAS), anchored from "Very Unstable" to "Very Stable".	Immediately after each footwear condition during the baseline laboratory assessment.

Collaborators and Investigators

• Sponsor: University of Salford

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): January 15, 2027

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Balance; Stability; Walking; Gait Analysis; Transtibial Amputation; Footwear; Prosthetics; Lower Limb Prosthesis; Prosthetic Limb
• Other Study ID Numbers: 365897

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The study team has not yet made a final decision regarding the sharing of individual participant data (IPD). Any future data sharing will be subject to participant consent, ethical approval requirements, institutional policies, and data protection regulations. If data are shared, all information will be de-identified to protect participant confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No