Health TrialsbyHealthPanel

Impact of Footwear on Gait in Unilateral Transtibial Amputees

ConditionsTranstibial AmputationLower Limb AmputationProsthesis Users
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Salford

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Crossover

Treatments tested in this trial

  • Own Footwear

    Device

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

  • Oxford Shoe

    Device

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

  • Walking/Running Shoe

    Device

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

  • Rocker Shoe

    Device

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

Treatment groups

15 Participants
are divided into 4 treatment groups
Group A: Own FootwearActive comparator 1 intervention
Group B: Oxford ShoeExperimental treatment 1 intervention
Group C: Walking/Running ShoeExperimental treatment 1 intervention
Group D: Rocker ShoeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)
2

Stride length

Stride length measured using three-dimensional motion capture during walking under each footwear condition.

Time frame
Baseline (single laboratory assessment)
3

Cadence

Cadence measured using three-dimensional motion capture during walking under each footwear condition.

Time frame
Baseline (single laboratory assessment)
4

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)

Secondary outcomes

1

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.
2

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Salford

Lead sponsor

Source ClinicalTrials.gov
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