A Comparison Between Ischial-Containment and Sub-Ischial Prosthetic Sockets to Determine Their Effects on Secondary Health Conditions | NCT07768072 | Trialant

Not yet recruitingObservationalUpdated Aug 17, 2026

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

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07768072
Lead Sponsor: VA Office of Research and DevelopmentFED
Overall Status: Not yet recruiting
Study Type: Observational
Enrollment: 45Estimated
Last Update Posted: Aug 17, 2026Actual
Start Date: Jan 1, 2027Estimated
Primary Completion Date: Jul 1, 2030Estimated
Completion Date: Dec 31, 2030Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: A Comparison Between Ischial-Containment and Sub-Ischial Prosthetic Sockets to Determine Their Effects on Secondary Health Conditions
Brief Summary: 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.
Detailed Description

Conditions

The medical conditions and diseases this study investigates.

Unilateral Transfemoral Amputation

Interventions

The treatments and procedures being evaluated in this study.

No interventions

There are no interventions for this study.

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Eligibility Criteria: 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.)

Design

How the study is designed and how its participant groups are organized.

Observational Model: Cohort
Time Perspective: Cross-Sectional

Contacts

The people to reach with questions about this study or how to join it.

Rebecca Stine, MSContact

rebecca.stine@va.gov(312) 503-5726

Locations

Where the study is run and whether each site is currently recruiting.

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois 60612, United States

Collaborators

The organizations and people involved in this study.

Lead Sponsor: VA Office of Research and DevelopmentFED

Similar Studies

Other registered studies that closely resemble this one.

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.