Recruiting

Prosthetic Feet

Sponsor:

Massachusetts Institute of Technology

Code:

NCT05265403

Conditions

Amputation of Lower Limb Below Knee

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Commercially-available energy storage and return prosthetic foot

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

Study Details

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

Study ID

NCT05265403

Start date

Mar 3, 2022

Status verified date

Feb, 2022

Completion date

Aug 31, 2022

Anticipated

Primary completion date

Jul 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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.

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.

Primary outcome measure

  • Number of patients who prefer each prosthetic foot tested for each walking activity [ Time Frame: 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 [ Time Frame: At the end of study completion, after ~4 hours of total time on a single day to acclimate to all prosthetic feet tested ]

Central Contacts and Locations

Central contacts

Charlotte M Folinus, SB

4042451422cfolinus@mit.edu

Locations

Hanger Clinic

Recruiting

Salt Lake City, Utah, United States, 84109

Contacts

Phil Stevens, MEd, CPO

385-419-3610pstevens@hanger.com

More Information

Sponsor

Massachusetts Institute of Technology

Last update posted

Apr 12, 2022

Last verified

Feb, 2022

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Massachusetts Institute of Technology on 2022-04-12.