Transtibial AmputationNCT07685496
Impact of Footwear on Gait in Unilateral Transtibial Amputees
A study testing Own Footwear, Oxford Shoe and Walking/Running Shoe in people with Transtibial Amputation and Lower Limb Amputation, run by University of Salford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Transtibial Amputation, Lower Limb Amputation, Prosthesis Users
- What is being tested?
- Own Footwear, Oxford Shoe and Walking/Running Shoe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Nov 2026to 15 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Salford
Manchester, Greate Manchester, M6 6PU
Abdulaziz Alkanderi, PhD Candidate, +447443673361, a.alkanderi1@edu.salford.ac.uk
Richard Jones, Professor
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Being tested
- Own Footwear, Oxford Shoe, Walking/Running Shoe, Rocker Shoe
- Keywords
- Footwear, Prosthetics, Transtibial Amputation, Gait Analysis, Walking, Balance, Stability, Prosthetic Limb, Lower Limb Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Own FootwearDevice
Participants wear their own regularly used footwear while completing gait and standing assessments in a motion analysis laboratory.
Oxford ShoeDevice
Participants wear a standard Oxford shoe while completing gait and standing assessments in a motion analysis laboratory.
Walking/Running ShoeDevice
Participants wear a walking/running shoe while completing gait and standing assessments in a motion analysis laboratory.
Rocker ShoeDevice
Participants wear a rocker shoe while completing gait and standing assessments in a motion analysis laboratory.
| Study group | Role | What they receive |
|---|---|---|
| Own Footwear | Active comparator | Participants complete walking and balance assessments while wearing their own regularly used footwear. Receives: Device: Own Footwear |
| Oxford Shoe | Experimental | Participants complete walking and balance assessments while wearing a standard Oxford shoe. Receives: Device: Oxford Shoe |
| Walking/Running Shoe | Experimental | Participants complete walking and balance assessments while wearing a walking/running shoe. Receives: Device: Walking/Running Shoe |
| Rocker Shoe | Experimental | Participants complete walking and balance assessments while wearing a rocker shoe. Receives: Device: Rocker Shoe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed
Gait speed measured using three-dimensional motion capture and force plate analysis during walking under each footwear condition.
Measured: Baseline (single laboratory assessment)
Stride length
Stride length measured using three-dimensional motion capture during walking under each footwear condition.
Measured: Baseline (single laboratory assessment)
Cadence
Cadence measured using three-dimensional motion capture during walking under each footwear condition.
Measured: 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.
Measured: Baseline (single laboratory assessment)
Foot clearance time
Foot clearance time measured using three-dimensional motion capture under each footwear condition.
Measured: Baseline (single laboratory assessment)
Ground reaction forces
Ground reaction forces measured using force plate analysis during walking under each footwear condition.
Measured: Baseline (single laboratory assessment)
Stance phase duration
Stance phase duration measured using three-dimensional motion capture and force plate analysis under each footwear condition.
Measured: 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.
Measured: Baseline (single laboratory assessment)
Secondary outcomes (2)
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".
Measured: 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".
Measured: Immediately after each footwear condition during the baseline laboratory assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start3 Nov 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transtibial AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685496
- Sponsor's protocol ID
- 365897
- Status last verified
- Aug 2026
- First submitted
- 23 Jun 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.