Transfemoral AmputationNCT07204912
Evaluation of a Neural-Controlled Powered Prosthesis Across Diverse Real-World Tasks
A study testing MIT Powered Leg in people with Transfemoral Amputation, run by Massachusetts Institute of Technology at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the performance and adaptability of a neural-controlled powered knee or ankle prosthesis across diverse real-world mobility tasks. This research aims to assess how compare the sense of embodiment with the device, symmetry, and stability of a person with an lower-extremity… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Transfemoral Amputation
- What is being tested?
- MIT Powered Leg
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2025to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female age 18-70.
- The patient must have a unilateral transfemoral amputation .
- The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above).
- The patient must have adequate socket to support the device.
Who cannot join
- Women who are pregnant.
- Severe co morbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectancy, vulnerable patient population, BMI >40, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MIT Media Lab
Cambridge, Massachusetts, 02139
John A McCullough, B.S. Mechanical Engineering, 424-603-1074, johnmccu@mit.edu
About this study
The purpose of this study is to evaluate the performance and adaptability of a neural-controlled powered knee or ankle prosthesis across diverse real-world mobility tasks. This research aims to assess how compare the sense of embodiment with the device, symmetry, and stability of a person with an lower-extremity amputation walking with a bionic prosthesis and their prescribed prosthesis. Findings from this study will inform future developments in bionic prosthesis design with optimal integration with the human body, with the goal of improving prosthetic integration into daily life.
- Conditions
- Transfemoral Amputation
- Being tested
- MIT Powered Leg
- Keywords
- Transfemoral Amputation, Bionic Prosthesis, Knee Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIT Powered LegDevice
MIT powered knee prosthesis developed by the MIT Biomechatronics Group.
| Study group | Role | What they receive |
|---|---|---|
| MIT Powered Leg | Experimental | Subjects wears the MIT powered knee-ankle prosthesis. Receives: Device: MIT Powered Leg |
| Prescribed prosthesis | No intervention | Subjects wears their prescribed prosthesis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematic and Kinetic Measures of Lower-Limb Biomechanics
Quantitative analysis of lower-limb biomechanics, including joint angles, ground reaction forces, joint torques, and mechanical power during level-ground walking, stair negotiation, and other functional tasks. Outcomes will be assessed using a motion capture system (e.g., Vicon), instrumented force plates, and embedded prosthesis sensors to evaluate gait symmetry, stability, and mechanical efficiency.
Measured: An average of 2 sessions in the span of 1 week
Spatiotemporal Gait Parameters
Evaluation of spatiotemporal gait parameters during ambulation with the powered prosthesis. Specific measures include stride length, cadence, walking speed, and stance-to-swing ratio. Parameters will be obtained using a motion capture system (e.g., Vicon) and an instrumented walkway. Data will be analyzed to assess functional walking ability and compared to normative or baseline values
Measured: An average of 2 sessions in the span of 1 week
Assessment of Patient Ability to Control each Joint of the Prosthesis
Assessment of volitional control of the powered knee and ankle joints via neural signals from the residual limb. Participants will perform isolated joint control trials in seated positions. Outcomes include joint command accuracy, latency, and repeatability, evaluated using surface electromyography (EMG) and motion capture. These measures will quantify the participant's ability to intentionally control each prosthetic joint.
Measured: An average of 2 sessions in the span of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start31 May 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfemoral AmputationStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugh Herr, Principal investigator, MIT Media Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204912
- Sponsor's protocol ID
- 2503001589
- Status last verified
- Sep 2025
- First submitted
- 16 Jun 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Subject confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Neural-Controlled Powered Prosthesis Across Diverse Real-World Tasks
- ClinicalTrials.gov ID
- NCT07204912
- Acronym / sponsor ID
- 2503001589
- Conditions
- Transfemoral Amputation
- Keywords
- Transfemoral Amputation, Bionic Prosthesis, Knee Prosthesis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Massachusetts Institute of TechnologyUniversity, hospital or other
- Study start
- 31 May 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 2 Oct 2025 (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 study is to evaluate the performance and adaptability of a neural-controlled powered knee or ankle prosthesis across diverse real-world mobility tasks. This research aims to assess how compare the sense of embodiment with the device, symmetry, and stability of a person with an lower-extremity amputation walking with a bionic prosthesis and their prescribed prosthesis. Findings from this study will inform future developments in bionic prosthesis design with optimal integration with the human body, with the goal of improving prosthetic integration into daily life.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIT Powered Leg | Experimental | Device: MIT Powered LegSubjects wears the MIT powered knee-ankle prosthesis. |
| Prescribed prosthesis | No intervention | –Subjects wears their prescribed prosthesis. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or Female age 18-70.
- The patient must have a unilateral transfemoral amputation .
- The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above).
- The patient must have adequate socket to support the device.
Key exclusion criteria (2 listed)
- Women who are pregnant.
- Severe co morbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectancy, vulnerable patient population, BMI >40, etc.).
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 |
|---|---|---|
| MIT Powered LegMIT powered knee prosthesis developed by the MIT Biomechatronics Group. | Device | MIT Powered Leg |
Primary outcome
Kinematic and Kinetic Measures of Lower-Limb Biomechanics
Time frame: An average of 2 sessions in the span of 1 week
Quantitative analysis of lower-limb biomechanics, including joint angles, ground reaction forces, joint torques, and mechanical power during level-ground walking, stair negotiation, and other functional tasks. Outcomes will be assessed using a motion capture system (e.g., Vicon), instrumented force plates, and embedded prosthesis sensors to evaluate gait symmetry, stability, and mechanical efficiency.
Spatiotemporal Gait Parameters
Time frame: An average of 2 sessions in the span of 1 week
Evaluation of spatiotemporal gait parameters during ambulation with the powered prosthesis. Specific measures include stride length, cadence, walking speed, and stance-to-swing ratio. Parameters will be obtained using a motion capture system (e.g., Vicon) and an instrumented walkway. Data will be analyzed to assess functional walking ability and compared to normative or baseline values
Assessment of Patient Ability to Control each Joint of the Prosthesis
Time frame: An average of 2 sessions in the span of 1 week
Assessment of volitional control of the powered knee and ankle joints via neural signals from the residual limb. Participants will perform isolated joint control trials in seated positions. Outcomes include joint command accuracy, latency, and repeatability, evaluated using surface electromyography (EMG) and motion capture. These measures will quantify the participant's ability to intentionally control each prosthetic joint.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: Undecided. Subject confidentiality.
Related trials for Transfemoral Amputation
Active, not recruiting
Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training
Amputation, Transfemoral Amputation
Not yet recruiting
Impact of Anterior Load Carriage on Gait in Individuals With Transfemoral Amputation
Unilateral Transfemoral Amputation in Prosthetic Users
Not yet recruiting
Effect of a Microprocessor-controlled Prosthetic Knee Joint on K2 Level Ambulators
Transfemoral Amputation, Limb Loss
Recruiting
A Biomechanical Evaluation of the Ossur Power Knee in Persons With Transfemoral Amputation
Transfemoral Amputation, Limb Loss
RecruitingObservational study
Assessment of Strength, Balance, and Function in Above-Knee Amputees in Relation to Residual Limb Length
Transfemoral Amputation
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.
Hugh Herr principal investigator
MIT Media Lab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIT Powered Leg in people with Transfemoral Amputation, 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 2 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John A McCullough, B.S. Mechanical Engineering (424-603-1074, johnmccu@mit.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinematic and Kinetic Measures of Lower-Limb Biomechanics (time frame: An average of 2 sessions in the span of 1 week). The study lists 3 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 2 Oct 2025; AzTrials last refreshed its copy on 6 Nov 2026.