AmputationNCT07645729
Evaluation of a Powered Ankle Prosthesis Capable of Bidirectional Control Via Neural Recording and Cutaneous Stimulation in Free-Space and Walking Tasks
A study testing Powered Prosthesis and Prescribed Prosthesis in people with 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 of a powered ankle prosthesis capable of bidirectional control via neural recording and cutaneous stimulation, during free-space and walking tasks. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation
- What is being tested?
- Powered Prosthesis and Prescribed Prosthesis
- 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
- 21 Oct 2025to 30 Sep 2031
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female age 18-70. The patient must have a unilateral transtibial 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
Christopher Shallal, B.S., 704-904-6112, cshallal@mit.edu
About this study
The purpose of this study is to evaluate the performance of a powered ankle prosthesis capable of bidirectional control via neural recording and cutaneous stimulation, during free-space and walking tasks. This research aims to assess the sense of embodiment with the device, gait symmetry, and stability of a person with lower-extremity amputation walking with a powered ankle and their prescribed prosthesis. Findings from this study will inform future developments in bionic ankle design with optimal integration with the human body, with the goal of improving prosthetic integration into daily life.
Read the detailed description
In summary there will be 3 cohorts in this study, 1) a group of subjects that have an osseointegrated fixture with implanted electrodes, 2) a group that does not have implanted electrodes, and 3) non-amputee healthy control group to serve as a baseline comparison. In summary, the groups will be asked to wear a number of non-invasive sensors and the amputee groups will use a powered ankle prosthesis in place of their customary prosthesis. Data will be collected from various wearable sensors and other motion-capture devices as the subjects walk. At certain points during the study, the control settings of the powered prosthesis will be adjusted, either manually or automatically. Trials will also be conducted with the subjects prescribed prosthesis.
- Conditions
- Amputation
- Being tested
- Powered Prosthesis, Prescribed Prosthesis
- Keywords
- prosthesis, neuroprosthesis, osseointegration, amputation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powered ProsthesisDevice
This powered prosthesis has the capability of providing active neural control of an ankle joint, and its control can be adjusted through a wireless link. It is motorized to provide positive power during walking.
Prescribed ProsthesisDevice
Subject's prescribed prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Powered Prosthesis | Experimental | The subject will be provided with a powered ankle prosthesis to attach in place of their customary prosthesis. This powered prosthesis has the capability of providing active neural control of an ankle joint, and its control can be adjusted through a wireless link. The subject will be given as much time as necessary to practice using the prosthesis before the experiments begin. Receives: Device: Powered Prosthesis |
| Prescribed Prosthesis | Active comparator | The subject will be undergo the same experiments with their prescribed ankle prosthesis to act as a comparison to the standard of care. Receives: Device: Prescribed Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematic Measures of Lower-Limb Biomechanics
Quantitative analysis of lower-limb kinematics (joint angles in degrees) during level-ground walking, stair navigation, and other functional tasks.
Measured: Multiple sessions across 1-2 weeks
Kinetic Measures of Lower-Limb Biomechanics
Quantitative analysis of kinetic biomechanics including ground reaction and joint forces (Newtons) during level-ground walking, stair navigation, and other functional tasks.
Measured: Multiple sessions across 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start21 Oct 2025
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Device feasibility
- 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
- Principal investigator, Christopher Shallal, Massachusetts Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645729
- Sponsor's protocol ID
- 2508001761
- Status last verified
- Jun 2026
- First submitted
- 2 Mar 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data may contain identifying information.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Powered Ankle Prosthesis Capable of Bidirectional Control Via Neural Recording and Cutaneous Stimulation in Free-Space and Walking Tasks
- ClinicalTrials.gov ID
- NCT07645729
- Acronym / sponsor ID
- 2508001761
- Conditions
- Amputation
- Keywords
- prosthesis, neuroprosthesis, osseointegration, amputation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Massachusetts Institute of TechnologyUniversity, hospital or other
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 12 Jun 2026 (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 of a powered ankle prosthesis capable of bidirectional control via neural recording and cutaneous stimulation, during free-space and walking tasks. This research aims to assess the sense of embodiment with the device, gait symmetry, and stability of a person with lower-extremity amputation walking with a powered ankle and their prescribed prosthesis. Findings from this study will inform future developments in bionic ankle design with optimal integration with the human body, with the goal of improving prosthetic integration into daily life.
Detailed description
In summary there will be 3 cohorts in this study, 1) a group of subjects that have an osseointegrated fixture with implanted electrodes, 2) a group that does not have implanted electrodes, and 3) non-amputee healthy control group to serve as a baseline comparison. In summary, the groups will be asked to wear a number of non-invasive sensors and the amputee groups will use a powered ankle prosthesis in place of their customary prosthesis. Data will be collected from various wearable sensors and other motion-capture devices as the subjects walk. At certain points during the study, the control settings of the powered prosthesis will be adjusted, either manually or automatically. Trials will also be conducted with the subjects prescribed prosthesis.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Powered Prosthesis | Experimental | Device: Powered ProsthesisThe subject will be provided with a powered ankle prosthesis to attach in place of their customary prosthesis. This powered prosthesis has the capability of providing active neural control of an ankle joint, and its control can be adjusted through a wireless link. The subject will be given as much time as necessary to practice using the prosthesis before the experiments begin. |
| Prescribed Prosthesis | Active comparator | Device: Prescribed ProsthesisThe subject will be undergo the same experiments with their prescribed ankle prosthesis to act as a comparison to the standard of care. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or Female age 18-70. The patient must have a unilateral transtibial 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 (1 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 |
|---|---|---|
| Powered ProsthesisThis powered prosthesis has the capability of providing active neural control of an ankle joint, and its control can be adjusted through a wireless link. It is motorized to provide positive power during walking. | Device | Powered Prosthesis |
| Prescribed ProsthesisSubject's prescribed prosthesis | Device | Prescribed Prosthesis |
Primary outcome
Kinematic Measures of Lower-Limb Biomechanics
Time frame: Multiple sessions across 1-2 weeks
Quantitative analysis of lower-limb kinematics (joint angles in degrees) during level-ground walking, stair navigation, and other functional tasks.
Kinetic Measures of Lower-Limb Biomechanics
Time frame: Multiple sessions across 1-2 weeks
Quantitative analysis of kinetic biomechanics including ground reaction and joint forces (Newtons) during level-ground walking, stair navigation, and other functional tasks.
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 12 Jun 2026.
- Individual participant dataSharing planned: No. Data may contain identifying information.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Powered Prosthesis and Prescribed Prosthesis in people with 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 2 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: looking for participants now, as of the sponsor's last update on 12 Jun 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinematic Measures of Lower-Limb Biomechanics (time frame: Multiple sessions across 1-2 weeks). 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 Jun 2026.