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Impact of Footwear on Gait in Unilateral Transtibial Amputees

2026年8月17日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

15

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • イギリス
    • Greate Manchester
      • Manchester、Greate Manchester、イギリス、M6 6PU
        • 募集
        • University of Salford
        • コンタクト：
        • 主任研究者：
          • Richard Jones, Professor

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：基礎科学
  • 割り当て：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：Own Footwear
Participants complete walking and balance assessments while wearing their own regularly used footwear.
デバイス：Own Footwear
Participants wear their own regularly used footwear while completing gait and standing assessments in a motion analysis laboratory.
実験的：Oxford Shoe
Participants complete walking and balance assessments while wearing a standard Oxford shoe.
デバイス：Oxford Shoe
Participants wear a standard Oxford shoe while completing gait and standing assessments in a motion analysis laboratory.
実験的：Walking/Running Shoe
Participants complete walking and balance assessments while wearing a walking/running shoe.
デバイス：Walking/Running Shoe
Participants wear a walking/running shoe while completing gait and standing assessments in a motion analysis laboratory.
実験的：Rocker Shoe
Participants complete walking and balance assessments while wearing a rocker shoe.
デバイス：Rocker Shoe
Participants wear a rocker shoe while completing gait and standing assessments in a motion analysis laboratory.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Gait speed
時間枠：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
時間枠：Baseline (single laboratory assessment)
Stride length measured using three-dimensional motion capture during walking under each footwear condition.
Baseline (single laboratory assessment)
Cadence
時間枠：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
時間枠：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
時間枠：Baseline (single laboratory assessment)
Foot clearance time measured using three-dimensional motion capture under each footwear condition.
Baseline (single laboratory assessment)
Ground reaction forces
時間枠：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
時間枠：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
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Perceived footwear comfort
時間枠：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
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Salford

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2026年12月15日

研究の完了 (推定)

2027年1月15日

試験登録日

最初に提出

2026年6月23日

QC基準を満たした最初の提出物

2026年7月1日

最初の投稿 (実際)

2026年7月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月19日

QC基準を満たした最後の更新が送信されました

2026年8月17日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • 365897

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

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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いいえ

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