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

2026년 8월 12일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

편측 경퇴부 절단

상세 설명

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.

연구 유형

관찰

등록 (추정된)

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Rebecca Stine, MS
전화번호: (312) 503-5726
이메일: rebecca.stine@va.gov

연구 연락처 백업

이름: Steven A Gard, PhD
전화번호: (312) 503-5718
이메일: steven.gard@va.gov

연구 장소

미국
- Illinois
  - Chicago, Illinois, 미국, 60612
    - Jesse Brown VA Medical Center, Chicago, IL
    - 연락하다:
      
      Rebecca Stine, MS
      
      전화번호: (312) 503-5726
      
      이메일: rebecca.stine@va.gov
    - 연락하다:
      
      Steven A Gard, PhD
      
      전화번호: (312) 503-5718
      
      이메일: steven.gard@va.gov
    - 수석 연구원:
      
      Rebecca Stine, MS

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

성인
고령자

건강한 자원 봉사자를 받아들입니다

예

샘플링 방법

비확률 샘플

연구 인구

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

설명

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.)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트 그룹/코호트 생물 의학 또는 건강 결과에 대해 평가되는 관찰 연구의 참가자 그룹 또는 하위 그룹입니다.
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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Anterior Pelvic Tilt Angle Between the IC Socket wearers and the SI Socket wearers/Able-Bodied Controls 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
Electromyography (EMG) Activity of the Lumbar Erector Spinae Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

VA Office of Research and Development

수사관

수석 연구원: Rebecca Stine, MS, Jesse Brown VA Medical Center, Chicago, IL

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2027년 1월 1일

기본 완료 (추정된)

2030년 7월 1일

연구 완료 (추정된)

2030년 12월 31일

연구 등록 날짜

최초 제출

2026년 8월 4일

QC 기준을 충족하는 최초 제출

2026년 8월 12일

처음 게시됨 (실제)

2026년 8월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)