Amputation of Lower Limb Below KneeNCT05265403
Evaluation of High-Performance, Customized, Rapidly-Manufacturable Prosthetic Feet That Provide Improved Mobility
An observational study of Amputation of Lower Limb Below Knee, run by Massachusetts Institute of Technology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Amputation of Lower Limb Below Knee
- What is being tested?
- Commercially-available energy storage and return prosthetic foot and MIT-Lower Leg Trajectory Error (LLTE) customized prosthetic feet
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2022to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Hanger Clinic
Salt Lake City, Utah, 84109
Phil Stevens, MEd, CPO, 385-419-3610, pstevens@hanger.com
About this study
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.
Read the 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
- Being tested
- Commercially-available energy storage and return prosthetic foot, MIT-Lower Leg Trajectory Error (LLTE) customized prosthetic feet
- Keywords
- transtibial amputation, below knee amputation, prosthetic device design, biomechanics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercially-available energy storage and return prosthetic footDrug
Also called Freedom Highlander
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 feetDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Commercially-available energy storage and return prosthetic foot; Device: MIT-Lower Leg Trajectory Error (LLTE) customized prosthetic feet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At the end of study completion, after ~4 hours of total time on a single day to acclimate to all prosthetic feet tested
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start3 Mar 2022
- Primary completion30 Jul 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation of Lower Limb Below KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Hanger Clinic: Prosthetics & Orthotics
- Responsible party
- Sponsor
- Investigators
- Amos G Winter, PhD, Principal investigator, Massachusetts Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265403
- Sponsor's protocol ID
- 2106000399
- Status last verified
- Feb 2022
- First submitted
- 26 Jan 2022
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The aggregated data will be kept for several years in order to compare the performance of this prototype with the performance of future prototypes. Data collected will be subjective feedback, information about prosthetic foot alignment, and biomechanical data about walking patterns, none of which is particularly sensitive. While participant data is not particularly sensitive, it pertains to intellectual property of new prosthetic foot designs, and we will not be making the individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of High-Performance, Customized, Rapidly-Manufacturable Prosthetic Feet That Provide Improved Mobility
- ClinicalTrials.gov ID
- NCT05265403
- Acronym / sponsor ID
- 2106000399
- Conditions
- Amputation of Lower Limb Below Knee
- Keywords
- transtibial amputation, below knee amputation, prosthetic device design, biomechanics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Massachusetts Institute of TechnologyUniversity, hospital or other
- Collaborators
- Hanger Clinic: Prosthetics & Orthotics
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Below knee amputees | – | Drug: Commercially-available energy storage and return prosthetic foot, Device: MIT-Lower Leg Trajectory Error (LLTE) customized prosthetic feetAdult, unilateral trans-tibial amputees (amputation is below the knee and only on one side) who will wear and test our prototype prosthetic feet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Commercially-available energy storage and return prosthetic footAlso: Freedom HighlanderEach 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. | Drug | Below knee amputees |
| MIT-Lower Leg Trajectory Error (LLTE) customized prosthetic feetEach 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. | Device | Below knee amputees |
Primary outcome
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
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.
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Page with overview of the MIT researcher's projectLink provided by the sponsor.
- Individual participant dataSharing planned: No. The aggregated data will be kept for several years in order to compare the performance of this prototype with the performance of future prototypes. Data collected will be subjective feedback, information about prosthetic foot alignment, and biomechanical data about walking patterns, none of which is particularly sensitive. While participant data is not particularly sensitive, it pertains to intellectual property of new prosthetic foot designs, and we will not be making the individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amos G Winter, PhD principal investigator
Massachusetts Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation of Lower Limb Below Knee, run by Massachusetts Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlotte M Folinus, SB (4042451422, cfolinus@mit.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.