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Impact of Footwear on Gait in Unilateral Transtibial Amputees

17. august 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

15

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Storbritannia
    • Greate Manchester
      • Manchester, Greate Manchester, Storbritannia, M6 6PU
        • Rekruttering
        • University of Salford
        • Ta kontakt med:
        • Hovedetterforsker:
          • Richard Jones, Professor

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Salford

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

15. desember 2026

Studiet fullført (Antatt)

15. januar 2027

Datoer for studieregistrering

Først innsendt

23. juni 2026

Først innsendt som oppfylte QC-kriteriene

1. juli 2026

Først lagt ut (Faktiske)

6. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 365897

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

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.

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Nei

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