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

Conditions

• Unilateral Transfemoral Amputation

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Accepted

Study Details

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.

Key Dates

First listed

Aug 17, 2026

Start date

Jan 1, 2027

Status verified

Aug 2026

Primary completion

Jul 1, 2030

Completion

Dec 31, 2030

Study Design

Enrollment

45 participants (estimated)

Arms

• Arm: Ischial Containment Socket user
  Person with unilateral transfemoral amputation wearing an ischial containment socket
• Arm: Sub-Ischial Socket user
  Person with unilateral transfemoral amputation wearing a sub-ischial socket
• Arm: Able-bodied control
  Person without an amputation

Primary Outcome Measure

Anterior Pelvic Tilt Angle Between the IC Socket wearers and the SI Socket wearers/Able-Bodied Controls [ Time Frame: To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe ]

Central Contacts

• Rebecca Stine, MS
  (312) 503-5726
  [email protected]
• Steven A Gard, PhD
  (312) 503-5718
  [email protected]

Locations (1)

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