- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07768072
A Comparison Between Ischial-Containment and Sub-Ischial Prosthetic Sockets to Determine Their Effects on Secondary Health Conditions
연구 개요
상태
정황
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
등록 (추정된)
연락처 및 위치
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
-
-
Illinois
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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
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
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
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
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
수사관
- 수석 연구원: Rebecca Stine, MS, Jesse Brown VA Medical Center, Chicago, IL
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- RRD2-014-25W
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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