Evaluation of a Neural-Controlled Powered Prosthesis Across Diverse Real-World Tasks
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MIT Powered Leg.
- Who it may be relevant to
- Registry conditions: Transfemoral Amputation. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device MIT Powered Leg
MIT powered knee prosthesis developed by the MIT Biomechatronics Group.
Primary outcome measures
- Kinematic and Kinetic Measures of Lower-Limb Biomechanics [Time frame: An average of 2 sessions in the span of 1 week]
- Spatiotemporal Gait Parameters [Time frame: An average of 2 sessions in the span of 1 week]
- Assessment of Patient Ability to Control each Joint of the Prosthesis [Time frame: An average of 2 sessions in the span of 1 week]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- MIT Media Lab — Cambridge
Identifiers
NCT: NCT07204912 · 2503001589