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Evaluation of High-Performance, Customized, Rapidly-Manufacturable Prosthetic Feet That Provide Improved Mobility

NCT05265403 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2022-04-12

No results posted yet for this study

Summary

The purpose of this research is to design a high-performance, customized, and rapidly- manufacturable passive prosthetic foot for use in the United States. We are currently testing an early stage prototype and would like user input before pursuing additional clinical testing. Participants will be asked about their current prosthesis type and use, amputation side and cause, and activity level. We will take measurements of height, weight, and length of the participant's residual limb. The participant will be asked to walk in several prosthetic foot conditions in multiple walking activities, and the visit should last approximately four hours.

For each prosthetic foot, a trained prosthetist will fit the foot (either a prototype foot or a commercially available K3/K4 foot) to the prosthesis. The patient will then walk around the room until they feel comfortable. They may initially walk using a gait belt or between parallel bars based on comfort level and an evaluation by the prosthetist. Once they feel comfortable walking on level ground at a normal speed and the prosthetist feels that they will be safe performing more challenging walking activities, the participant will perform different walking activities (such as walking on flat ground at different speeds, walking up/down ramps, and walking up/down stairs). They will then be asked to tell the investigator what they like and dislike about the prosthetic foot.

Conditions

  • Amputation of Lower Limb Below Knee

Interventions

DRUG

Commercially-available energy storage and return prosthetic foot

Each patient will walk in the Freedom Highlander, a commercially-available energy storage and return prosthetic foot. The foot will be sized based on the patient's foot size and weight.

DEVICE

MIT-Lower Leg Trajectory Error (LLTE) customized prosthetic feet

Each patient will walk in prosthetic feet designed by the researchers at MIT. These feet will be customized for the user based on their body size (ie, height, foot length) and weight.

Sponsors & Collaborators

Principal Investigators

  • Amos G Winter, PhD · Massachusetts Institute of Technology

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-03
Primary Completion
2022-07-30
Completion
2022-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05265403 on ClinicalTrials.gov