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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

Qualifiers

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)

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

Disqualifiers

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.)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

45 Participants
are grouped into 3 trial groups