Low Cost Prosthetic Socket for Amputation

Overseen By Laura Miller, PhD, CP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Cognitive impairment, Stroke, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

8 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to test an investigational fabrication system for transtibial prostheses. This fabrication method will be tested for comfort and function to determine feasibility of use for amputees in developing countries. To address the need for high quality and affordable prosthetic technology in developing countries, the investigators have developed a simplified socket fitting protocol using expandable rigid foam. The foam is formed by mixing small amounts of two liquid components, which typically expands to several times its original volume.

Eligibility Criteria

This trial is for unilateral transtibial amputees who had their amputation at least 6 months ago, can walk independently, and currently have a comfortable prosthesis. Participants must be able to understand English but cannot join if they have cognitive impairments, significant other health issues, certain limb shapes that don't fit the system, open wounds on the limb, or can't understand English.

Inclusion Criteria

I had one lower leg amputated over 6 months ago and can walk on my own.

I can walk with some assistance or independently.

Your prosthetic limb fits well and you have given it a comfort score of at least 6 out of 10.

Exclusion Criteria

I understand and can follow the study's requirements.

Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study (e.g stroke, pacemaker placement, etc), or that would otherwise prevent acquisition of usable data by researchers.

The shape of your remaining limb is too big and won't fit within the prosthetic system's size limits.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Fabrication and Testing

Fabrication and testing of a low cost lower limb prosthetic socket to ensure appropriate suspension, comfort, and function for a transtibial amputee

1 day

1 visit (in-person)

Outcome Measures Assessment

Assessment of functional mobility and comfort using various tests such as the L-Test of Functional Mobility, Amputee Mobility Predictor, and Socket Comfort Score

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the initial testing

2-4 weeks

Treatment Details

Interventions

• Low cost lower limb prosthetic socket

Trial Overview The study tests a new low-cost method for making prosthetic sockets using expandable rigid foam. This could help amputees in developing countries get quality prosthetics. The comfort and function of this new socket are being compared to current options.

Participant Groups

Group I: Low cost lower limb socket testing Experimental Treatment 1 Intervention

Fabrication and testing of a low cost lower limb prosthetic socket and ensure this socket has appropriate suspension, comfort and f unction for a transtibial amputee.

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+