An interventional study of Own Footwear and Oxford Shoe in Transtibial Amputation, Lower Limb Amputation and Prosthesis Users, sponsored by University of Salford. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by University of Salford · Not applicable, Interventional, and Basic science
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:
Participants will:
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.
University of Salford is the lead sponsor of 27 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants complete walking and balance assessments while wearing their own regularly used footwear.
Device: Own Footwear
Participants complete walking and balance assessments while wearing a standard Oxford shoe.
Device: Oxford Shoe
Participants complete walking and balance assessments while wearing a walking/running shoe.
Device: Walking/Running Shoe
Participants complete walking and balance assessments while wearing a rocker shoe.
Device: Rocker Shoe
Participants wear their own regularly used footwear while completing gait and standing assessments in a motion analysis laboratory.
Participants wear a standard Oxford shoe while completing gait and standing assessments in a motion analysis laboratory.
Participants wear a walking/running shoe while completing gait and standing assessments in a motion analysis laboratory.
Participants wear a rocker shoe while completing gait and standing assessments in a motion analysis laboratory.
Gait speed
Gait speed measured using three-dimensional motion capture and force plate analysis during walking under each footwear condition.
Time frame: Baseline (single laboratory assessment)
Stride length
Stride length measured using three-dimensional motion capture during walking under each footwear condition.
Time frame: Baseline (single laboratory assessment)
Cadence
Cadence measured using three-dimensional motion capture during walking under each footwear condition.
Time frame: 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.
Time frame: Baseline (single laboratory assessment)
Foot clearance time
Foot clearance time measured using three-dimensional motion capture under each footwear condition.
Time frame: Baseline (single laboratory assessment)
Ground reaction forces
Ground reaction forces measured using force plate analysis during walking under each footwear condition.
Time frame: Baseline (single laboratory assessment)
Stance phase duration
Stance phase duration measured using three-dimensional motion capture and force plate analysis under each footwear condition.
Time frame: 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.
Time frame: Baseline (single laboratory assessment)
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".
Time frame: 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".
Time frame: Immediately after each footwear condition during the baseline laboratory assessment.
Plan to share: Undecided — 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Salford