Amputation StumpNCT03544853
Computational Design, Fabrication, and Evaluation of Optimized Patient-Specific Transtibial Prosthetic Sockets
A study testing Prosthetic socket for transtibial amputee in people with Amputation Stump, run by Massachusetts Institute of Technology at 2 sites in 2 countries.
Trial summary
The overall goal of this study is to further develop and clinically assess a computational and data-driven design and manufacturing framework for mechanical interfaces that quantitatively produces transtibial prosthetic sockets in a faster and more cost-effective way than conventional processes. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation Stump
- What is being tested?
- Prosthetic socket for transtibial amputee
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Sep 2017to 31 Aug 2022
- Phase
- Interventional
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-64 years old
- Amputation type: Transtibial amputation (bilateral or unilateral) which took place >1 year prior to study
- Activity or K-level: At least K3
- Socket quality: The subject's conventional socket(s) should be deemed of high quality and comfortable
- MRI safety: Subjects should be able to undergo MRI
Who cannot join
- -
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Massachusetts Institute of Technology, Media Lab
Cambridge, Massachusetts, 02142
Mexico1 site
Tecnologico de Monterrey, Biomechatronics Lab
Nuevo México, Jalisco, 45201
About this study
The overall goal of this study is to further develop and clinically assess a computational and data-driven design and manufacturing framework for mechanical interfaces that quantitatively produces transtibial prosthetic sockets in a faster and more cost-effective way than conventional processes. The main hypothesis of this proposal is that the novel quantitative interface is equivalent to, or better than, a conventional interface in terms of: 1) gait symmetry, 2) skin contact pressures, 3) skin surface temperature, and 4) comfort as evaluated from a questionnaire.
Read the detailed description
Title: Computational Design, Fabrication, and Evaluation of Optimized Patient-Specific Transtibial Prosthetic Sockets
Principle Investigator: Dr. Hugh Herr
Background: The overall goal of this application is to further develop and clinically assess a computational and data-driven design and manufacturing framework for mechanical interfaces that quantitatively produces transtibial prosthetic sockets in a faster and more cost-effective way than conventional processes. Traditionally, prosthetic socket production has been a craft activity, based primarily on the experience of the prosthetist. Even with advances in computer-aided design and computer-aided manufacturing (CAD/CAM), the design process remains manual. The manual nature of the process means it is non-repeatable and currently largely non-data-driven, and quantitative data is either not obtained or insufficiently employed. Furthermore, discomfort, skin problems and pressure ulcer formation remain prevalent. Through the proposed computational modeling framework, a repeatable, data-driven and patient-specific design process is made available which is based on scientific rationale.
Objective/hypothesis: The main hypothesis of this proposal is that a socket, designed using the novel computational design framework, is equivalent to, or better than, a conventional socket (designed by a prosthetist) in terms of: 1) gait symmetry, 2) skin contact pressures, 3) skin surface temperature, and 4) comfort as evaluated from a questionnaire. Our hypothesis is supported by the presented pilot data which shows reduced or equivalent skin contact pressures and subject reported comfort levels for several critical anatomical regions.
Specific Aims: 1) Subject-specific biomechanical modeling for N=18 subjects, 2) Computational design and fabrication of sockets for N=18 subjects, and 3) Clinical evaluation of novel sockets for N=18 subjects.
Study Design: A cohort of 18 subjects will be recruited for this study. MRI or CT data will be recorded for all subjects. Through image segmentation geometrically accurate 3D finite element analysis (FEA) models will be constructed. The resulting predictive FEA models will then be used in a novel, data-driven, and automated computational design framework for prosthetic sockets, to design prosthetic sockets for all subjects. The framework optimizes the socket designs, as assessed by skin contact pressures and internal tissue strain, through iterative adjustment of the virtual tests sockets. Final designs are subsequently 3D printed. To evaluate the prosthetic sockets with each of the subjects each subject will do a standing and walking exercise using their conventional sockets or the novel sockets. Meanwhile skin contact pressures and temperatures are recorded, gait symmetry data is collecetd, and socket comfort is assessed using a questionnaire. Together this data provides a quantitative and qualitative evaluation and comparison of the novel and conventional sockets.
- Conditions
- Amputation Stump
- Being tested
- Prosthetic socket for transtibial amputee
- Keywords
- Prosthetic socket, Biomechanics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic socket for transtibial amputeeDevice
To wear a prosthetic socket for evaluation of comfort and biomechanical metrics such as skin loading conditions.
| Study group | Role | What they receive |
|---|---|---|
| Prosthetic socket evaluation | Experimental | Intervention: Prosthetic socket for transtibial amputee. A subject's conventional prosthetic socket is compared to a novel prosthetic socket designed as part of the research. For standing and walking exercises the following will be assessed. 1) local skin contact pressures, 2) metabolic power, 3) gait parameters (symmetry indices for joint angles, positions, torques, and also ground reaction forces), and 4) the socket evaluation questionnaire. Receives: Device: Prosthetic socket for transtibial amputee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local skin pressure while wearing a socket
Local skin contact pressures (in Newton per square meter) are assessed using pressure sensors positioned on the skin surface. Local pressures relate to comfort which is the topic of investigation. These measurements are performed during the (clinical) socket comfort evaluation phase which is typically 3 months after the initial data acquisition phase for each subject. Measurements take place once and in a single session. As such only a single time point is investigated (the time point of the experiment is not a relevant or investigated parameter). The data is compared across subjects and socket types.
Measured: Assessed once during (clinical) socket comfort evaluation phase. Measurements are for standing and walking exercises for the conventional and novel socket.
Skin surface temperature difference
Skin surface temperatures (in Celsius) are assessed using a Flir thermal camera, with images taken immediately post-kinematic walking trial. From these measurements the average residuum skin surface temperature is assessed for 4 different view directions: anterior, posterior, medial, and lateral. Measurements take place once and in a single session. As such only a single time point is investigated (the time point of the experiment is not a relevant or investigated parameter). The data is compared across subjects and socket types.
Measured: Assessed once during (clinical) socket comfort evaluation phase. Measurements are for standing and walking exercises for the conventional and novel socket.
Gait parameter asymmetry
Socket fit (and discomfort) influences musculoskeletal behavior and may alter gait patterns. Subjects are equipped with markers tracked (units of mm) using a motion capture system (T40s, Vicon Motion Systems Ltd, Oxford, UK). Ground reaction forces (units Newton) are also recorded. From these measurements gait symmetry indices for: joint angles, positions, torques, and ground reaction forces, are computed. These measurements are performed during the (clinical) socket comfort evaluation phase which is typically 3 months after the initial data acquisition phase for each subject. Measurements take place once and in a single session. As such only a single time point is investigated (the time point of the experiment is not a relevant or investigated parameter). The data is compared across subjects and socket types.
Measured: Assessed once during (clinical) socket comfort evaluation phase. Measurements are for standing and walking exercises for the conventional and novel socket.
Socket evaluation questionnaire
Socket fit and discomfort is assessed using a questionnaire created to document patient experiences and preferences while using prosthetic interfaces (liners, sockets) both over a longitudinal timeline and on an immediate basis. After establishing subject baselines for socket use, patients complete a section that instructs them to evaluate the novel prosthetic socket provided against their conventional prosthetic socket. Subjects complete the questionnaire via a HIPAA compliant surveying instrument on Redcap, and questions are tailored to minimize bias through adoption of verified metrics (such as those from the TAPES-R instrument) or by the use of sliding scales that eliminate the need for constrained integer number input. The data is analyzed by subject, across subjects as a whole, and socket types.
Measured: Assessed once during (clinical) socket comfort evaluation phase. Measurements are for sitting, standing and walking exercises for the conventional and novel socket.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start15 Sep 2017
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation StumpStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor
- Investigators
- Hugh M Herr, PhD, Principal investigator, Massachusetts Institute of Technology, Media Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544853
- Sponsor's protocol ID
- 1101004280
- Other IDs
- R01EB024531-01
- Status last verified
- Sep 2022
- First submitted
- 19 Apr 2018
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computational Design, Fabrication, and Evaluation of Optimized Patient-Specific Transtibial Prosthetic Sockets
- ClinicalTrials.gov ID
- NCT03544853
- Acronym / sponsor ID
- 1101004280
- Conditions
- Amputation Stump
- Keywords
- Prosthetic socket, Biomechanics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Massachusetts Institute of TechnologyUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 4 Jun 2018 (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 overall goal of this study is to further develop and clinically assess a computational and data-driven design and manufacturing framework for mechanical interfaces that quantitatively produces transtibial prosthetic sockets in a faster and more cost-effective way than conventional processes. The main hypothesis of this proposal is that the novel quantitative interface is equivalent to, or better than, a conventional interface in terms of: 1) gait symmetry, 2) skin contact pressures, 3) skin surface temperature, and 4) comfort as evaluated from a questionnaire.
Detailed description
Title: Computational Design, Fabrication, and Evaluation of Optimized Patient-Specific Transtibial Prosthetic Sockets
Principle Investigator: Dr. Hugh Herr
Background: The overall goal of this application is to further develop and clinically assess a computational and data-driven design and manufacturing framework for mechanical interfaces that quantitatively produces transtibial prosthetic sockets in a faster and more cost-effective way than conventional processes. Traditionally, prosthetic socket production has been a craft activity, based primarily on the experience of the prosthetist. Even with advances in computer-aided design and computer-aided manufacturing (CAD/CAM), the design process remains manual. The manual nature of the process means it is non-repeatable and currently largely non-data-driven, and quantitative data is either not obtained or insufficiently employed. Furthermore, discomfort, skin problems and pressure ulcer formation remain prevalent. Through the proposed computational modeling framework, a repeatable, data-driven and patient-specific design process is made available which is based on scientific rationale.
Objective/hypothesis: The main hypothesis of this proposal is that a socket, designed using the novel computational design framework, is equivalent to, or better than, a conventional socket (designed by a prosthetist) in terms of: 1) gait symmetry, 2) skin contact pressures, 3) skin surface temperature, and 4) comfort as evaluated from a questionnaire. Our hypothesis is supported by the presented pilot data which shows reduced or equivalent skin contact pressures and subject reported comfort levels for several critical anatomical regions.
Specific Aims: 1) Subject-specific biomechanical modeling for N=18 subjects, 2) Computational design and fabrication of sockets for N=18 subjects, and 3) Clinical evaluation of novel sockets for N=18 subjects.
Study Design: A cohort of 18 subjects will be recruited for this study. MRI or CT data will be recorded for all subjects. Through image segmentation geometrically accurate 3D finite element analysis (FEA) models will be constructed. The resulting predictive FEA models will then be used in a novel, data-driven, and automated computational design framework for prosthetic sockets, to design prosthetic sockets for all subjects. The framework optimizes the socket designs, as assessed by skin contact pressures and internal tissue strain, through iterative adjustment of the virtual tests sockets. Final designs are subsequently 3D printed. To evaluate the prosthetic sockets with each of the subjects each subject will do a standing and walking exercise using their conventional sockets or the novel sockets. Meanwhile skin contact pressures and temperatures are recorded, gait symmetry data is collecetd, and socket comfort is assessed using a questionnaire. Together this data provides a quantitative and qualitative evaluation and comparison of the novel and conventional sockets.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prosthetic socket evaluation | Experimental | Device: Prosthetic socket for transtibial amputeeIntervention: Prosthetic socket for transtibial amputee. A subject's conventional prosthetic socket is compared to a novel prosthetic socket designed as part of the research. For standing and walking exercises the following will be assessed. 1) local skin contact pressures, 2) metabolic power, 3) gait parameters (symmetry indices for joint angles, positions, torques, and also ground reaction forces), and 4) the socket evaluation questionnaire. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: 18-64 years old
- Amputation type: Transtibial amputation (bilateral or unilateral) which took place >1 year prior to study
- Activity or K-level: At least K3
- Socket quality: The subject's conventional socket(s) should be deemed of high quality and comfortable
- MRI safety: Subjects should be able to undergo MRI
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Prosthetic socket for transtibial amputeeTo wear a prosthetic socket for evaluation of comfort and biomechanical metrics such as skin loading conditions. | Device | Prosthetic socket evaluation |
Primary outcome
Local skin pressure while wearing a socket
Time frame: Assessed once during (clinical) socket comfort evaluation phase. Measurements are for standing and walking exercises for the conventional and novel socket.
Local skin contact pressures (in Newton per square meter) are assessed using pressure sensors positioned on the skin surface. Local pressures relate to comfort which is the topic of investigation. These measurements are performed during the (clinical) socket comfort evaluation phase which is typically 3 months after the initial data acquisition phase for each subject. Measurements take place once and in a single session. As such only a single time point is investigated (the time point of the experiment is not a relevant or investigated parameter). The data is compared across subjects and socket types.
Skin surface temperature difference
Time frame: Assessed once during (clinical) socket comfort evaluation phase. Measurements are for standing and walking exercises for the conventional and novel socket.
Skin surface temperatures (in Celsius) are assessed using a Flir thermal camera, with images taken immediately post-kinematic walking trial. From these measurements the average residuum skin surface temperature is assessed for 4 different view directions: anterior, posterior, medial, and lateral. Measurements take place once and in a single session. As such only a single time point is investigated (the time point of the experiment is not a relevant or investigated parameter). The data is compared across subjects and socket types.
Gait parameter asymmetry
Time frame: Assessed once during (clinical) socket comfort evaluation phase. Measurements are for standing and walking exercises for the conventional and novel socket.
Socket fit (and discomfort) influences musculoskeletal behavior and may alter gait patterns. Subjects are equipped with markers tracked (units of mm) using a motion capture system (T40s, Vicon Motion Systems Ltd, Oxford, UK). Ground reaction forces (units Newton) are also recorded. From these measurements gait symmetry indices for: joint angles, positions, torques, and ground reaction forces, are computed. These measurements are performed during the (clinical) socket comfort evaluation phase which is typically 3 months after the initial data acquisition phase for each subject. Measurements take place once and in a single session. As such only a single time point is investigated (the time point of the experiment is not a relevant or investigated parameter). The data is compared across subjects and socket types.
Socket evaluation questionnaire
Time frame: Assessed once during (clinical) socket comfort evaluation phase. Measurements are for sitting, standing and walking exercises for the conventional and novel socket.
Socket fit and discomfort is assessed using a questionnaire created to document patient experiences and preferences while using prosthetic interfaces (liners, sockets) both over a longitudinal timeline and on an immediate basis. After establishing subject baselines for socket use, patients complete a section that instructs them to evaluate the novel prosthetic socket provided against their conventional prosthetic socket. Subjects complete the questionnaire via a HIPAA compliant surveying instrument on Redcap, and questions are tailored to minimize bias through adoption of verified metrics (such as those from the TAPES-R instrument) or by the use of sliding scales that eliminate the need for constrained integer number input. The data is analyzed by subject, across subjects as a whole, and socket types.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Hugh M Herr, PhD principal investigator
Massachusetts Institute of Technology, Media Lab
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prosthetic socket for transtibial amputee in people with Amputation Stump, run by Massachusetts Institute of Technology at 2 sites in 2 countries.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Mexico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local skin pressure while wearing a socket (time frame: Assessed once during (clinical) socket comfort evaluation phase. Measurements are for standing and walking exercises for the conventional and novel socket.). The study lists 4 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 30 Sep 2022.