Active Knee Prosthesis Study for Improvement of Locomotion for Above Knee Amputees
The Active Knee Prosthesis Will be Tested to Evaluate How Well it Improves the Gait Symmetry and Reduces the Metabolic Cost of an Amputee During Walking. The Prosthesis Will be Attached to the Socket of the Amputee.
1 other identifier
interventional
10
1 country
2
Brief Summary
The purpose of this study is to develop a robust, low-power, stable, and light weight, active knee prosthetic device that can dramatically increase gait symmetry and walking economy of a transfemoral amputee during walking. State of the art prosthetic knees can be classified into three main classes: a) mechanically passive, b) variable-damping, and c) powered. Although the devices within each of these classes offer some advantages for above-knee amputees, their overall performance still presents some deficiencies. Artificial knees in the first two groups are predominantly damping devices, incapable of providing positive power output. Moreover, current powered prostheses are heavy and inefficient in their energy consumption, and/or they have a limited range of motion. To overcome such inadequacies, we have designed a novel prosthetic knee device with a biomimetic approach. The design of the active knee prosthesis is inspired by the antagonistic muscle anatomy of the human knee joint. This device mimics the synergistic muscle activity at the knee using a double series-elastic actuator (SEA) system that resembles the major mono-articular muscle groups that help flex and extend the knee joint. The agonist-antagonist SEA knee architecture will allow for precise force control of the knee joint, mimicking the spring-like behavior of the human knee, as well as providing adequate energy for forward progression of the body. The SEA has been previously developed and tested on legged robots. Also, the SEA has been successfully applied to the development of an actuated ankle-foot orthoses (AAFO) at MIT AI Lab. The mechanical architecture of the active knee prosthesis allows for independent engagement of flexion and extension tendon-like, series springs for the control of joint position and impedance, as well as net joint torque. Furthermore, this architecture permits a joint rotation with near zero friction, allowing the controller to take advantage of the passive dynamics of the system, thus, augmenting the overall energetic efficiency of the system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2008
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 8, 2008
CompletedFirst Posted
Study publicly available on registry
October 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedOctober 13, 2008
October 1, 2008
8 months
October 8, 2008
October 10, 2008
Conditions
Study Arms (1)
Prosthesis
EXPERIMENTALMotorized External Knee prosthesis for above knee amputees. Comprised of agonist and antagonist actuators to mimic behavior of knee joint during locomotion.
Interventions
Motorized External Knee Prosthesis for above knee amputees.
Eligibility Criteria
You may qualify if:
- They will be experienced at prosthesis ambulation
- Capacity of ambulation at least at a K3 level (i.e. having the ability or potential for ambulation with variable cadence).
You may not qualify if:
- Amputee participants will be generally healthy and will have no other musculoskeletal problems or any known cardiovascular, pulmonary or neurological disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Biomechatronics Research Group, MIT
Cambridge, Massachusetts, 02142, United States
LIfestyle Prosthetics & Orthotics
North Andover, Massachusetts, 01845, United States
Related Publications (1)
Martinez-Villalpando EC, Herr H. Agonist-antagonist active knee prosthesis: a preliminary study in level-ground walking. J Rehabil Res Dev. 2009;46(3):361-73.
PMID: 19675988DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Hugh Herr, Ph.D.
Massachusetts Institute of Technology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
Study Record Dates
First Submitted
October 8, 2008
First Posted
October 13, 2008
Study Start
May 1, 2008
Primary Completion
January 1, 2009
Study Completion
April 1, 2009
Last Updated
October 13, 2008
Record last verified: 2008-10