Impact of Footwear on Gait in Unilateral Transtibial Amputees

NCT07685496 | Not Yet Recruiting

• 1 other identifier: 365897
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Footwear; Prosthetics; Transtibial Amputation; Gait Analysis; Walking; Balance; Stability; Prosthetic Limb; Lower Limb Prosthesis

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• 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.

Study Arms (4)

Own Footwear

ACTIVE COMPARATOR

Participants complete walking and balance assessments while wearing their own regularly used footwear.

Device: Own Footwear

Oxford Shoe

EXPERIMENTAL

Participants complete walking and balance assessments while wearing a standard Oxford shoe.

Device: Oxford Shoe

Walking/Running Shoe

EXPERIMENTAL

Participants complete walking and balance assessments while wearing a walking/running shoe.

Device: Walking/Running Shoe

Rocker Shoe

EXPERIMENTAL

Participants complete walking and balance assessments while wearing a rocker shoe.

Device: Rocker Shoe

Interventions

Own Footwear DEVICE

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

Own Footwear

Oxford Shoe DEVICE

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

Oxford Shoe

Walking/Running Shoe DEVICE

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

Walking/Running Shoe

Rocker Shoe DEVICE

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

Rocker Shoe

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salford: lead

Study Sites (1)

University of Salford

Manchester, Greate Manchester, M6 6PU, United Kingdom

Location

Central Study Contacts

Abdulaziz Alkanderi, PhD Candidate

CONTACT

+447443673361; A.Alkanderi1@edu.salford.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will complete walking tasks under multiple footwear conditions, including their own footwear, an Oxford shoe, a walking/running shoe, and a rocker shoe. All participants will experience all footwear conditions, allowing within-subject comparison of gait and stability outcomes.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Locations

GB (1)