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

NCT05265403 | Unknown

• 1 other identifier: 2106000399
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation of Lower Limb Below Knee

Keywords

transtibial amputation; below knee amputation; prosthetic device design; biomechanics

Outcome Measures

Primary Outcomes (2)

• Number of patients who prefer each prosthetic foot tested for each walking activity

  For each walking activity, subjects will qualitatively select which foot option they prefer for each activity (ie, standing, walking at varied speeds on level ground, and walking up/down ramps). Subjects will provide this information through a questionnaire where they indicate their preferred foot for each activity.

  At the end of study completion, after ~4 hours of total time on a single day to acclimate to all prosthetic feet tested

• Mean difference in prosthetic foot evaluation score between prototype prosthetic feet and commercial prosthetic feet, as assessed by a self-reported questionnaire

  For each prosthetic foot, patients will fill out a questionnaire, which is a modified form of the standardized prosthesis evaluation questionnaire (PEQ). The PEQ is a clinically-validated, self-report questionnaire used to assess the prosthesis and life with the prosthesis. Questions are evaluated on a Likert scale (ie, "Strongly disagree" to "Strongly agree") which will be converted to numerical values. A low score represents a poor rating (the patient did not like the device) and a high score represents a strong rating. The overall outcome measure is the difference in total score (totaled across all questions) between each foot condition. The score for an individual foot represents an overall evaluation of that prosthesis, which we will average across participants and compare between feet. The difference in scores evaluates the feasibility of the prototype foot compared with the subject's own, daily-use prosthesis as well as the commercially available control prosthetic foot.

  At the end of study completion, after ~4 hours of total time on a single day to acclimate to all prosthetic feet tested

Study Arms (1)

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

Drug: Commercially-available energy storage and return prosthetic foot; Device: MIT-Lower Leg Trajectory Error (LLTE) customized prosthetic feet

Interventions

Commercially-available energy storage and return prosthetic foot 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.

Also known as: Freedom Highlander

Below knee amputees

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

Below knee amputees

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• Massachusetts Institute of Technology: lead
• Hanger Clinic: Prosthetics & Orthotics: collaborator

Study Sites (1)

Hanger Clinic

Salt Lake City, Utah, 84109, United States

RECRUITING

Related Links

• Page with overview of the MIT researcher's project

Study Officials

• Amos G Winter, PhD

  Massachusetts Institute of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte M Folinus, SB

CONTACT

4042451422; cfolinus@mit.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: March 3, 2022
• Study Start: March 3, 2022
• Primary Completion: July 30, 2022
• Study Completion: August 31, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)