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

Status unconfirmed

Conditions studied: Amputation of Lower Limb Below Knee

In brief

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.

Key facts

Study ID

NCT05265403

Run by

Massachusetts Institute of Technology

People needed

40

Starts

2022-03-03

Expected to finish

2022-08-31

Last updated by the study team

2022-04-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unilateral transtibial amputation
• Aged between 18-65 years
• Body mass index between 18.5-29.9 (healthy weight)
• Daily use of their clinically-prescribed prosthesis for ambulation without an assistive device
• Classified as at least a Medicare Functional Classification Level K3 (defined as a patient who is a typical unlimited community ambulator)
• Experience walking with a prosthesis for at least one year
• Residuum and amputated side in good condition (e.g., no adherent scars, lesions, ulcers, or infections)
• Normal or corrected vision
• Ability to walk continuously for 45 minutes without undue fatigue or health risks.

You may not qualify if…

• Subjects who weigh more than 200 pounds
• Poor fitting prosthetic socket
• Skin problems on the residual limb
• Co-morbidities or pathologies (other than the amputation) or medications that would affect the sound limb, spine, balance, or stability
• Decision by prosthetists at Hanger that walking on the prototype limb may pose higher than minimal risk for a potential subject.

Where it is running

• Hanger Clinic — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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