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

NCT ID: NCT05265403

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-03
• Study Completion Date: 2022-08-31

Brief 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.

Detailed Description

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 your input before pursuing additional clinical testing. The Global Engineering and Research (GEAR) Laboratory at the Massachusetts Institute of Technology (MIT) has developed a novel design framework for creating high-performance, passive prosthetic feet. By incorporating commercial aesthetic and functional requirements, we hypothesize that we can use this design methodology to create high-performance prosthetic feet that can be customized and provided at scale in the United States.

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 you like and dislike about the prosthetic foot.

Participants may also be asked to walk while wearing inertial measurement units (IMU's), which are wearable devices similar in size to a pedometer or wrist watch. These devices will record the acceleration of the limbs, which will allow us to understand how people walk in the different prosthetic feet. We will attach the IMU's using their elastic bands, and we will attach necessary wires with hypoallergenic tape. Wearing the IMU's, the participant will walk back and forth in the room while the sensors record information about how you are walking. They may rest at any time.

Conditions

Amputation of Lower Limb Below Knee

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Below knee amputees

Adult, unilateral trans-tibial amputees (amputation is below the knee and only on one side) who will wear and test our prototype prosthetic feet

Commercially-available energy storage and return prosthetic foot

Intervention Type: DRUG

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.

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Other Intervention Names

Freedom Highlander

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanger Clinic: Prosthetics & Orthotics

OTHER

Sponsor Role: collaborator

Massachusetts Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amos G Winter, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Institute of Technology

Locations

Hanger Clinic

Salt Lake City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Charlotte M Folinus, SB

Role: CONTACT

cfolinus@mit.edu

4042451422

Facility Contacts

Phil Stevens, MEd, CPO

Role: primary

pstevens@hanger.com

385-419-3610

Related Links

https://www.gear.mit.edu/prosthetic-foot

Page with overview of the MIT researcher's project

Other Identifiers

2106000399

Identifier Type: -

Identifier Source: org_study_id