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NCT07685496
Impact of Footwear on Gait in Unilateral Transtibial Amputees
Conditions: Transtibial Amputation, Lower Limb Amputation, Prosthesis Users
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 15
Sponsor: University of Salford
Location: University of Salford Manchester Greate Manchester
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07685496). StuddyBuddy aggregates publicly available trial information.