Impact of Footwear on Gait in Unilateral Transtibial Amputees
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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Abdulaziz Alkanderi, PhD Candidate
- Telefonnummer: +447443673361
- E-Mail: a.alkanderi1@edu.salford.ac.uk
Studienorte
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Greate Manchester
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Manchester, Greate Manchester, Vereinigtes Königreich, M6 6PU
- Rekrutierung
- University of Salford
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Kontakt:
- Abdulaziz Alkanderi, PhD Candidate
- Telefonnummer: +447443673361
- E-Mail: a.alkanderi1@edu.salford.ac.uk
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Hauptermittler:
- Richard Jones, Professor
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: Own Footwear
Participants complete walking and balance assessments while wearing their own regularly used footwear.
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Participants wear their own regularly used footwear while completing gait and standing assessments in a motion analysis laboratory.
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Experimental: Oxford Shoe
Participants complete walking and balance assessments while wearing a standard Oxford shoe.
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Participants wear a standard Oxford shoe while completing gait and standing assessments in a motion analysis laboratory.
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Experimental: Walking/Running Shoe
Participants complete walking and balance assessments while wearing a walking/running shoe.
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Participants wear a walking/running shoe while completing gait and standing assessments in a motion analysis laboratory.
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Experimental: Rocker Shoe
Participants complete walking and balance assessments while wearing a rocker shoe.
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Participants wear a rocker shoe while completing gait and standing assessments in a motion analysis laboratory.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Gait speed
Zeitfenster: Baseline (single laboratory assessment)
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Gait speed measured using three-dimensional motion capture and force plate analysis during walking under each footwear condition.
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Baseline (single laboratory assessment)
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Stride length
Zeitfenster: Baseline (single laboratory assessment)
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Stride length measured using three-dimensional motion capture during walking under each footwear condition.
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Baseline (single laboratory assessment)
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Cadence
Zeitfenster: Baseline (single laboratory assessment)
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Cadence measured using three-dimensional motion capture during walking under each footwear condition.
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Baseline (single laboratory assessment)
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Prosthetic foot clearance during swing phase
Zeitfenster: Baseline (single laboratory assessment)
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Prosthetic foot clearance during swing phase measured using three-dimensional motion capture under each footwear condition.
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Baseline (single laboratory assessment)
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Foot clearance time
Zeitfenster: Baseline (single laboratory assessment)
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Foot clearance time measured using three-dimensional motion capture under each footwear condition.
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Baseline (single laboratory assessment)
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Ground reaction forces
Zeitfenster: Baseline (single laboratory assessment)
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Ground reaction forces measured using force plate analysis during walking under each footwear condition.
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Baseline (single laboratory assessment)
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Stance phase duration
Zeitfenster: Baseline (single laboratory assessment)
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Stance phase duration measured using three-dimensional motion capture and force plate analysis under each footwear condition.
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Baseline (single laboratory assessment)
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Ankle power generated by the prosthetic foot
Zeitfenster: Baseline (single laboratory assessment)
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Ankle power generated by the prosthetic foot measured using three-dimensional motion capture and force plate analysis during walking under each footwear condition.
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Baseline (single laboratory assessment)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Perceived footwear comfort
Zeitfenster: Immediately after each footwear condition during the baseline laboratory assessment.
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Participant-rated comfort for each footwear condition using a 100 mm Visual Analogue Scale (VAS), anchored from "Extremely Uncomfortable" to "Extremely Comfortable".
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Immediately after each footwear condition during the baseline laboratory assessment.
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Perceived footwear stability
Zeitfenster: Immediately after each footwear condition during the baseline laboratory assessment.
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Participant-rated stability for each footwear condition using a 100 mm Visual Analogue Scale (VAS), anchored from "Very Unstable" to "Very Stable".
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Immediately after each footwear condition during the baseline laboratory assessment.
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 365897
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