Transfemoral AmputationNCT06700668
Active Knee Prosthesis Study
A study testing MIT Powered Knee in people with Transfemoral Amputation, run by Massachusetts Institute of Technology at 1 site in United States.
Trial summary
The purpose of the study is to investigate the clinical and functional outcomes of a powered knee prosthesis for people with a transfemoral amputation in the domain of gait, free space control, and embodiment Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Transfemoral Amputation
- What is being tested?
- MIT Powered Knee
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2008to 17 Jul 2026
- 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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female age 22-65.
- 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.
About this study
The purpose of the study is to investigate the clinical and functional outcomes of a powered knee prosthesis for people with a transfemoral amputation in the domain of gait, free space control, and embodiment
- Conditions
- Transfemoral Amputation
- Being tested
- MIT Powered Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIT Powered KneeDevice
MIT powered knee prosthesis developed by the MIT Biomechatronics Group.
| Study group | Role | What they receive |
|---|---|---|
| MIT Powered Knee | Experimental | Subjects wears the MIT powered knee prosthesis. Receives: Device: MIT Powered Knee |
| 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.
Metabolic cost
Effort of participants' walking measured via metabolic cost, which is measured using an mask that measures the Oxygen and Carbon dioxide levels.
Measured: An average of 2 sessions in the span of 1 week
Secondary outcomes (2)
Ground reaction force
Ground reaction forces will be measured via force plates on the ground.
Measured: An average of 2 sessions in the span of 1 week
Gait kinematics
Motion capture data will be collected using a validated system (e.g., Vicon, or similar motion capture software). Reflective markers will be placed on anatomical landmarks following a standard gait model. Kinematic measures, including joint angles (hip, knee, and ankle), step length, stride length, cadence, and walking speed, will be derived.
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 posted22 Nov 2024
- Study start17 Apr 2008
- Primary completion17 Jul 2025
- Study completion17 Jul 2026 (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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Hugh Herr, PhD, Principal investigator, Massachusetts Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700668
- Sponsor's protocol ID
- 0804002682
- Status last verified
- Oct 2025
- First submitted
- 4 Nov 2024
- Last updated
- 14 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 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Knee Prosthesis Study
- ClinicalTrials.gov ID
- NCT06700668
- Acronym / sponsor ID
- 0804002682
- Conditions
- Transfemoral Amputation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Massachusetts Institute of TechnologyUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- 17 Apr 2008 (actual)
- Primary completion
- 17 Jul 2025 (actual)
- Study completion
- 17 Jul 2026 (estimated)
- First posted
- 22 Nov 2024 (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 the study is to investigate the clinical and functional outcomes of a powered knee prosthesis for people with a transfemoral amputation in the domain of gait, free space control, and embodiment
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 Knee | Experimental | Device: MIT Powered KneeSubjects wears the MIT powered knee prosthesis. |
| Prescribed prosthesis | No intervention | –Subjects wears their prescribed prosthesis. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or Female age 22-65.
- 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 KneeMIT powered knee prosthesis developed by the MIT Biomechatronics Group. | Device | MIT Powered Knee |
Primary outcome
Metabolic cost
Time frame: An average of 2 sessions in the span of 1 week
Effort of participants' walking measured via metabolic cost, which is measured using an mask that measures the Oxygen and Carbon dioxide levels.
2 secondary outcomes
Ground reaction force
Time frame: An average of 2 sessions in the span of 1 week
Gait kinematics
Time frame: An average of 2 sessions in the span of 1 week
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 14 Oct 2025.
- Individual participant dataSharing planned: Undecided. Subject confidentiality.
Related trials for Transfemoral Amputation
Recruiting
Bio Leg: Advancing Mobility (BAM)
Amputation of Lower Limb Above Knee, Amputee
Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
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
Determining the Effects of Ischemic Conditioning and Neuromuscular Electrical Stimulation on Overall Function After Lower Limb Amputation
Lower Limb Amputation Above Knee, Below Knee 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. This study is not recruiting at the moment.
Hugh Herr, 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?
A study testing MIT Powered Knee 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: under way, not looking for participants, as of the sponsor's last update on 14 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?
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?
Metabolic cost (time frame: An average of 2 sessions in the span of 1 week). 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 14 Oct 2025.