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Impact of Footwear on Gait in Unilateral Transtibial Amputees

17 augustus 2026 bijgewerkt door: University of Salford

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:

  • 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

15

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigd Koninkrijk
    • Greate Manchester
      • Manchester, Greate Manchester, Verenigd Koninkrijk, M6 6PU
        • Werving
        • University of Salford
        • Contact:
        • Hoofdonderzoeker:
          • Richard Jones, Professor

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Own Footwear
Participants complete walking and balance assessments while wearing their own regularly used footwear.
Apparaat: Own Footwear
Participants wear their own regularly used footwear while completing gait and standing assessments in a motion analysis laboratory.
Experimenteel: Oxford Shoe
Participants complete walking and balance assessments while wearing a standard Oxford shoe.
Apparaat: Oxford Shoe
Participants wear a standard Oxford shoe while completing gait and standing assessments in a motion analysis laboratory.
Experimenteel: Walking/Running Shoe
Participants complete walking and balance assessments while wearing a walking/running shoe.
Apparaat: Walking/Running Shoe
Participants wear a walking/running shoe while completing gait and standing assessments in a motion analysis laboratory.
Experimenteel: Rocker Shoe
Participants complete walking and balance assessments while wearing a rocker shoe.
Apparaat: Rocker Shoe
Participants wear a rocker shoe while completing gait and standing assessments in a motion analysis laboratory.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Gait speed
Tijdsspanne: Baseline (single laboratory assessment)
Gait speed measured using three-dimensional motion capture and force plate analysis during walking under each footwear condition.
Baseline (single laboratory assessment)
Stride length
Tijdsspanne: Baseline (single laboratory assessment)
Stride length measured using three-dimensional motion capture during walking under each footwear condition.
Baseline (single laboratory assessment)
Cadence
Tijdsspanne: Baseline (single laboratory assessment)
Cadence measured using three-dimensional motion capture during walking under each footwear condition.
Baseline (single laboratory assessment)
Prosthetic foot clearance during swing phase
Tijdsspanne: Baseline (single laboratory assessment)
Prosthetic foot clearance during swing phase measured using three-dimensional motion capture under each footwear condition.
Baseline (single laboratory assessment)
Foot clearance time
Tijdsspanne: Baseline (single laboratory assessment)
Foot clearance time measured using three-dimensional motion capture under each footwear condition.
Baseline (single laboratory assessment)
Ground reaction forces
Tijdsspanne: Baseline (single laboratory assessment)
Ground reaction forces measured using force plate analysis during walking under each footwear condition.
Baseline (single laboratory assessment)
Stance phase duration
Tijdsspanne: Baseline (single laboratory assessment)
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
Tijdsspanne: Baseline (single laboratory assessment)
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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Perceived footwear comfort
Tijdsspanne: Immediately after each footwear condition during the baseline laboratory assessment.
Participant-rated comfort for each footwear condition using a 100 mm Visual Analogue Scale (VAS), anchored from "Extremely Uncomfortable" to "Extremely Comfortable".
Immediately after each footwear condition during the baseline laboratory assessment.
Perceived footwear stability
Tijdsspanne: Immediately after each footwear condition during the baseline laboratory assessment.
Participant-rated stability for each footwear condition using a 100 mm Visual Analogue Scale (VAS), anchored from "Very Unstable" to "Very Stable".
Immediately after each footwear condition during the baseline laboratory assessment.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Salford

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

15 december 2026

Studie voltooiing (Geschat)

15 januari 2027

Studieregistratiedata

Eerst ingediend

23 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

1 juli 2026

Eerst geplaatst (Werkelijk)

6 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

17 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 365897

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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