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A Comparison Between Ischial-Containment and Sub-Ischial Prosthetic Sockets to Determine Their Effects on Secondary Health Conditions

2026年8月12日 更新者:VA Office of Research and Development
Long-term above-knee prosthesis users are at an increased risk of developing secondary musculoskeletal conditions compared to the general able-bodied population. One secondary physical concern is low back pain (LBP), for which the development is not entirely understood, but in above-knee prosthesis users it is believed to relate to asymmetries and compensations that are typically demonstrated and required to stand and walk. Understanding spinal motion and compensations will enhance our knowledge of the factors contributing to LBP, and possibly lead to the development of new prosthetic and therapeutic interventions to prevent or alleviate LBP, thereby improving mobility and quality of life for prosthesis users.

調査の概要

状態

まだ募集していません

詳細な説明

The purpose of this study is to investigate and compare the effects of the standard ischial containment (IC) socket to a sub-ischial (SI) socket design on the spinal and pelvic motions and leg length (LLD) discrepancies of transfemoral prosthesis users. Data will be collected from 2 groups of transfemoral prosthesis users (15 SI socket wearers and 15 IC socket wearers) and a group of 15 able-bodied (AB) control participants. Gait and standing analyses will be conducted on each participant using a marker based motion capture system. Prosthesis users will wear their own conventional sockets for the gait and standing analyses. Kinematic and kinetic data will be analyzed for differences between the 2 groups of socket wearers and will also be compared to the control group.

The specific aims and hypotheses of this project are:

Aim 1: To measure dynamic leg length and kinematics of the pelvis and spinal segments in unilateral, transfemoral prosthesis users during gait. Quantitative motion analyses will be performed on two groups of 15 research participants with lower limb amputation using 2 different socket designs (IC and SI) walking over level ground at three self-selected walking speeds (normal, moderately fast, fastest). Data will be compared between socket type and to an AB control group. Hypothesis 1a-IC socket wearers will have a greater anterior pelvic tilt compared to SI socket wearers and AB controls, and they will exhibit considerably greater rotations of the pelvis and spinal segments during walking. Hypothesis 1b-The EMG activity of the lumbar erector spinae for SI socket users will better approximate the patterns of AB controls as compared to IC socket wearers. Hypothesis 1c-The dynamic LLD will be greater for IC socket users compared to SI socket wearers and AB controls.

Aim 2: To measure pelvic orientation and static leg length in unilateral, transfemoral prosthesis users during standing. A multi-segment model of the spine and pelvis will be used to determine neutral spinal, pelvis, and prosthetic alignment during standing for the research and AB control participants. Hypothesis 2a-IC socket wearers will demonstrate greater anterior pelvic tilt during standing compared to SI socket wearers and control participants. Hypothesis 2b-The prosthetic and sound leg lengths for both prosthesis user groups will be within 1.0 cm of each other during standing.

Aim 3: To estimate joint contact forces in the legs and lower back of unilateral, transfemoral prosthesis users and controls during gait. Computational musculoskeletal simulations will be used to comprehensively evaluate the data from Aim 1 to compare the lumbar joint loads between IC and SI socket wearers. Hypothesis 3-IC socket wearers will exhibit greater lumbar joint loads than SI socket wearers.

研究の種類

観察的

入学 (推定)

45

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

研究連絡先のバックアップ

  • 名前:Steven A Gard, PhD
  • 電話番号:(312) 503-5718
  • メール:steven.gard@va.gov

研究場所

    • Illinois
      • Chicago、Illinois、アメリカ、60612
        • Jesse Brown VA Medical Center, Chicago, IL
        • コンタクト:
        • コンタクト:
        • 主任研究者:
          • Rebecca Stine, MS

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

はい

サンプリング方法

非確率サンプル

調査対象母集団

Thirty unilateral transfemoral prosthesis users (15 with an ischial containment socket and 15 with a sub-ischial socket) and 15 able-bodied control participants.

説明

Inclusion Criteria:

For all participants:

  • Ability to complete the experimental protocol without undue fatigue or health risks
  • Low Back Pain scale assessment (0-10) less than 4 (activities of daily living or quality of life not impacted)

In addition for persons with lower limb amputation:

  • Prosthesis user for a minimum of 2 years with their current socket design
  • Good fit with either an ischial containment (IC) or sub-ischial (SI) socket
  • Good skin integrity on their residual limb upon visual inspection
  • Does not require the use of assistive devices to walk

Exclusion Criteria:

  • Previously diagnosed with a spine condition (e.g., pinched nerve, bulging disc, etc.)
  • Previously diagnosed with an orthopedic or neuromuscular condition that may affect walking or balance (e.g., ankle fusion, Parkinson's disease, stroke, etc.)

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

コホートと介入

グループ/コホート
Ischial Containment Socket user
Person with unilateral transfemoral amputation wearing an ischial containment socket
Sub-Ischial Socket user
Person with unilateral transfemoral amputation wearing a sub-ischial socket
Able-bodied control
Person without an amputation

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
Anterior Pelvic Tilt Angle Between the IC Socket wearers and the SI Socket wearers/Able-Bodied Controls
時間枠:To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Anterior Pelvic Tilt will be calculated for all participants during the walking and standing trials. Participants will walk along a 10 meter walkway at varying speeds. Quantitative motion analysis using a marker based motion measurement system will be used to calculate anterior pelvic tilt.
To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe

二次結果の測定

結果測定
メジャーの説明
時間枠
Electromyography (EMG) Activity of the Lumbar Erector Spinae Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
時間枠:To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
EMG activity will be assessed using surface electrodes attached bilaterally to the erector spinae at and below T12/L1 and on the external oblique muscle. Data will be collected during the quantitative motion analysis.
To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Lumbar Flexion Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
時間枠:To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Lumbar flexion will be calculated for all participants during the walking and standing trials. Participants will walk along a 10 meter walkway at varying speeds. Quantitative motion analysis using a marker based motion measurement system will be used to calculate anterior pelvic tilt.
To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Hip Joint Range of Motion (ROM) between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
時間枠:To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Hip Joint ROM will be calculated for all participants during the walking trials. Participants will walk along a 10 meter walkway at varying speeds. Quantitative motion analysis using a marker based motion measurement system will be used to calculate hip joint ROM.
To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Dynamic Leg Length Discrepancy (LLD) Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
時間枠:To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Dynamic LLD will be calculated for all participants during the walking trials. Participants will walk along a 10 meter walkway at varying speeds. Quantitative motion analysis using a marker based motion measurement system will be used to calculated dynamic LLD.
To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Peak Lumbar Joint Loading Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
時間枠:To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Lumbar joint loading during walking will be analyzed by performing musculoskeletal modeling simulations using data collected during the quantitative motion analysis.
To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe

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。

捜査官

  • 主任研究者:Rebecca Stine, MS、Jesse Brown VA Medical Center, Chicago, IL

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)

2027年1月1日

一次修了 (推定)

2030年7月1日

研究の完了 (推定)

2030年12月31日

試験登録日

最初に提出

2026年8月4日

QC基準を満たした最初の提出物

2026年8月12日

最初の投稿 (実際)

2026年8月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月17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12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

その他の研究ID番号

  • RRD2-014-25W

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?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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