Clinical trial NCT05265403: Evaluation of High-Performance, Customized, Rapidly-Manufacturable Prosthetic Feet That Provide Improved Mobility
Official title: Evaluation of High-Performance, Customized, Rapidly-Manufacturable Prosthetic Feet That Provide Improved Mobility
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amputation of Lower Limb Below Knee
Keywords: transtibial amputation
below knee amputation
prosthetic device design
biomechanics
Lead sponsor: Massachusetts Institute of Technology
Sponsor class: OTHER
Collaborators: name: Hanger Clinic: Prosthetics & Orthotics
First posted: 2022-03-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a unilateral transtibial amputation will be recruited through the Hanger Clinic. Subjects will likely be recruited who live in the Salt Lake City, Utah area, where data will be collected. Potential subjects will be screened to ensure that they satisfy the inclusion criteria. Screening will take place during the recruitment process either in person at the clinic or when the subject makes contact with the investigator. Subjects will be asked questions to ensure they meet the study inclusion criteria.

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.

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.

Primary outcomes:
measure: Number of patients who prefer each prosthetic foot tested for each walking activity
timeFrame: At the end of study completion, after ~4 hours of total time on a single day to acclimate to all prosthetic feet tested
measure: Mean difference in prosthetic foot evaluation score between prototype prosthetic feet and commercial prosthetic feet, as assessed by a self-reported questionnaire
timeFrame: At the end of study completion, after ~4 hours of total time on a single day to acclimate to all prosthetic feet tested
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Hanger Clinic
state: Utah
Study officials:
affiliation: Massachusetts Institute of Technology
name: Amos G Winter, PhD
role: PRINCIPAL_INVESTIGATOR
References: