Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Impact of Footwear on Gait in Unilateral Transtibial Amputees

1. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

15

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Det Forenede Kongerige
    • Greate Manchester
      • Manchester, Greate Manchester, Det Forenede Kongerige, M6 6PU
        • University of Salford
        • Kontakt:
        • Ledende efterforsker:
          • Richard Jones, Professor

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Own Footwear
Participants complete walking and balance assessments while wearing their own regularly used footwear.
Enhed: Own Footwear
Participants wear their own regularly used footwear while completing gait and standing assessments in a motion analysis laboratory.
Eksperimentel: Oxford Shoe
Participants complete walking and balance assessments while wearing a standard Oxford shoe.
Enhed: Oxford Shoe
Participants wear a standard Oxford shoe while completing gait and standing assessments in a motion analysis laboratory.
Eksperimentel: Walking/Running Shoe
Participants complete walking and balance assessments while wearing a walking/running shoe.
Enhed: Walking/Running Shoe
Participants wear a walking/running shoe while completing gait and standing assessments in a motion analysis laboratory.
Eksperimentel: Rocker Shoe
Participants complete walking and balance assessments while wearing a rocker shoe.
Enhed: Rocker Shoe
Participants wear a rocker shoe while completing gait and standing assessments in a motion analysis laboratory.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gait speed
Tidsramme: 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
Tidsramme: Baseline (single laboratory assessment)
Stride length measured using three-dimensional motion capture during walking under each footwear condition.
Baseline (single laboratory assessment)
Cadence
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline (single laboratory assessment)
Foot clearance time measured using three-dimensional motion capture under each footwear condition.
Baseline (single laboratory assessment)
Ground reaction forces
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Perceived footwear comfort
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Salford

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

15. december 2026

Studieafslutning (Anslået)

15. januar 2027

Datoer for studieregistrering

Først indsendt

23. juni 2026

Først indsendt, der opfyldte QC-kriterier

1. juli 2026

Først opslået (Faktiske)

6. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 365897

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Amputation af underekstremiteter

Kliniske forsøg med Own Footwear

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ghana

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner