Comparison of Various Prosthetic Foot-Ankle Mechanisms
Study Overview
Status
Conditions
Intervention / Treatment
- Device: MIT Sliding Beam Passive Prosthesis
- Device: Blatchford Elan Variable-Dampening Prosthesis
- Device: MIT Variable Stiffness Prosthesis v1
- Device: MIT Variable Equilibrium Angle Prosthesis v1
- Device: Ossur Pro-Flex XC
- Device: Ossur Proprio Variable Angle Prosthesis
- Device: MIT Variable Stiffness Prosthesis v2
- Device: MIT Variable Equilibrium Angle Prosthesis v2
Detailed Description
Subject Selection and Consent:
Subjects will be selected based on the following priority. Subjects who have previously participated in similar studies with the Biomechatronics lab and who have already been screened for health and mobility level will be contacted first. If additional subjects are needed, a recruitment flyer and screening questionnaire will be sent to potential candidates. Copies of both the flyer and questionnaire are included in the attachments section. Prior to the experimental sessions, subjects will be asked to read and sign a informed consent form and will explain the project to them and answer any questions that they may have. They will also be given time to become familiar with the equipment being used before beginning any trials. If needed, subjects will be aligned and fitted by a professional prosthetist at A Step Ahead Prosthetics in Burlington, MA. No personnel at A Step Ahead Prosthetics will conduct research or have any vested interest in research outcomes or publication.
Attire:
Subjects will be asked to wear tight-fitting clothes, such as a skin-tight shirt, running shorts and low-profile shoes. If this is not possible, clothes will be provided according to subject needs. The investigators will provide and may require subjects to wear a skin-tight Velcro outfit that allows us to place reflective balls for video camera capture.
Location(s) and Timeline:
Experimental sessions will be conducted in the MIT Biomechatronics Laboratory (E14-274), 75 Amherst St., Cambridge, MA 02139 and the basement connecting MIT Building 66, 68, and E19 (31 Ames St., Cambridge, MA 02139). The basement is a publicly accessible area, and visible signage will be posted to alert passerby. Any alignment and fitting of prosthetic devices will take place at either the aforementioned location or at A Step Ahead Prosthetics, 21 A. St., Burlington, MA 01803 by a trained prosthetist.
Total study duration is expected to be 8 hours per subject, likely over two 4-hour sessions. These sessions can be completed either in a single day or over two days.
Powered Prosthesis:
Subjects will be given three or four computer-controlled quasi-passive (QP) ankle-foot prostheses to attach in place of their customary prosthesis during a session, depending on the arm. These include the Blatchford Elan, Ossur Proprio, a variable-stiffness prosthesis (VSA), and a variable-angle prosthesis (VAA). These QP prostheses have the capability of providing active assistance or changing mechanical properties during walking. Controls will be adjusted either through a wireless link or hardwire connection depending on the device. Subjects will be given as much time as necessary to practice using the prostheses before the experiments begin.
Passive Prosthesis:
Subjects will be given 1-3 passive prostheses to attach in place of their customary prosthesis during a session. These include the Ossur Pro-Flex XC and a passive sliding-beam prosthesis based on the Variable Stiffness prosthesis above with the electronics and actuator removed. In the first arm, a passive prosthesis that can change ankle equilibrium angle manually will be used. Subjects will be given as much time as necessary to practice using the prosthesis before the experiments begin.
Data Collection:
Data collection is expected to take place in two segments. In the first segment, each subject will walk on a treadmill at three speeds between 0.5-1.5m/s (slow to fast walking), chosen based on their comfort. At each speed, all five prostheses will be tested, randomly selected, for 2mins each. Motion will be captured with a VICON motion capture system, and ground reaction forces will be measured using a Bertec force-sensitive treadmill. For each speed, once all prostheses have been tested, each subject will be given a questionnaire to ascertain how each prosthesis performed at heel strike (early stance), roll over (mid stance), and powered plantar flexion (late stance). In addition, each subject will be asked how each prosthesis generally performed, and their personal preference. This testing will occur across the three walking speeds, resulting in three completed questionnaires.
In addition, subjects will walk in a figure-8 pattern at a preferred gait speed around two cones placed on the level-ground walking surface and separated by up to 30 feet. Handrails and a harness will be available to the subject as needed. Subjects will perform the walking figure-8 for a minimum of 5 times for each randomly-selected prosthesis. Once all prostheses have been tested, each subject will be given a questionnaire to ascertain how each prosthesis generally performed, and their personal preference.
Each subject will ascend and descend stairs and a ramp inclined between 4°-8° from horizontal at their preferred speed, in a randomly selected order. This incline is akin to between an ADA-compliant wheelchair ramp and a moderately inclined hill. Motion will be captured with a VICON motion capture system, and ground reaction forces will be measured using a Bertec force-sensitive treadmill for slope ambulation, and a force-sensitive staircase for stair ambulation. All five prostheses will be tested, randomly selected. Subjects will perform each of stair ascent and stair descent for a minimum of 5 times per prosthesis. For slopes and stairs, subjects will be asked to test different stiffnesses and angles and pick a preferred setting for the VSA and VAA, respectively. Data will be collected for a total of 2mins for slope ascent and 2mins for slope descent with each prosthesis. If necessary, subjects will test up to 5 ankles on an ADA-compliant over-ground ramp for additional slope ascent and slope descent evaluation. This will provide additional evaluation of differences between treadmill and over-ground slope walking for both subject and researcher. Subjects will walk up and down the ramp a minimum of 5 times per prosthesis. Handrails are available along the entire ramp, and a researcher will be beside the subject for assistance. For each slope and stair ascent/descent, once all prostheses have been tested, each subject will be given a questionnaire to ascertain how each prosthesis generally performed, and their personal preference. This testing will occur across the slope terrain types, as well as after the stair ascent/descent trial, resulting in three completed questionnaires for each subject. If time allows, subjects may also be asked to test test up to 5 ankles a 30 ft. over-ground course consisting of level-ground, stairs, and slopes in order to evaluate transitions between terrains. Subjects will perform the course a minimum of 3 times. This will not be evaluated via questionnaire and is meant to provide information to the researcher on future prosthetic design. Handrails are available for all elements except an adjustable ramp, for which a researcher will be beside the subject for assistance.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Burlington, Massachusetts, United States, 01803
- A Step Ahead Prosthetics
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Cambridge, Massachusetts, United States, 02139
- MIT Media Laboratory
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Person with unilateral transtibial amputation
- K3 or K4 Medicare mobility rating
- Ages 18-65
Exclusion Criteria:
- Below K3 Medicare mobility rating
- Outside of age range (liability and safety reasons)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Evaluation of first generation prototype prostheses
Clinical trial to evaluate efficacy of first generation of MIT prototype prosthetic ankle-foot devices on people with unilateral transtibial amputation over different walking speeds and terrains.
|
Proprietary fixed-stiffness passive foot-ankle prosthesis.
Other Names:
Commercially-available electronically-controlled prosthesis that can vary its effective dampening.
Other Names:
Proprietary electronically-controlled prosthesis that can vary its effective stiffness.
Other Names:
Proprietary manually-controlled prosthesis that can vary its effective ankle equilibrium angle.
Other Names:
Commercially-available passive fixed-stiffness foot-ankle prosthesis by Ossur.
Other Names:
|
|
Experimental: Evaluation of second generation of prototype prostheses
Clinical trial to evaluate efficacy of second generation of MIT prototype prosthetic ankle-foot devices on people with unilateral transtibial amputation over different walking speeds and terrains.
|
Commercially-available electronically-controlled prosthesis that can vary its effective dampening.
Other Names:
Commercially-available passive fixed-stiffness foot-ankle prosthesis by Ossur.
Other Names:
Commercially available variable ankle angle prosthesis by Ossur.
Other Names:
Second generation a proprietary electronically-controlled prosthesis that can vary its effective stiffness.
Other Names:
Second generation prototype prosthesis that can vary its effective ankle equilibrium angle.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
User device preference for level-ground walking
Time Frame: From enrollment to the end of trial (2 sessions, 8 hours total per patient)
|
Determine which device the users prefer for level-ground walking by gauging user feedback through an evaluation questionnaire.
Evaluation units will be a sliding scale ranging from "Very unfavorable" to "Very favorable" with neutral in the middle.
Subjects will be asked to rank the 5 interventions from best to worst for the specific task.
|
From enrollment to the end of trial (2 sessions, 8 hours total per patient)
|
|
User device preference for stair ascent & descent
Time Frame: From enrollment to the end of trial (2 sessions, 8 hours total per patient)
|
Determine which device the users prefer for stair ascent & descent by gauging user feedback through an evaluation questionnaire.
Evaluation units will be a sliding scale ranging from "Very unfavorable" to "Very favorable" with neutral in the middle.
Subjects will be asked to rank the 5 interventions from best to worst for the specific task.
|
From enrollment to the end of trial (2 sessions, 8 hours total per patient)
|
|
User device preference for sloped ground ascent & descent
Time Frame: From enrollment to the end of trial (2 sessions, 8 hours total per patient)
|
Determine which device the users prefer for 8-degree sloped ground ascent & descent by gauging user feedback through an evaluation questionnaire.
Evaluation units will be a sliding scale ranging from "Very unfavorable" to "Very favorable" with neutral in the middle.
Subjects will be asked to rank the 5 interventions from best to worst for the specific task.
|
From enrollment to the end of trial (2 sessions, 8 hours total per patient)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of device on level-ground walking gait
Time Frame: From enrollment to the end of trial (2 sessions, 8 hours total per patient)
|
Evaluate the effect of the device on level-ground walking gait patterns.
Gait will be measured with a VICON motion capture system.
Unit of measure is gait symmetry.
|
From enrollment to the end of trial (2 sessions, 8 hours total per patient)
|
|
Effect of device on stair ascent & descent gait
Time Frame: From enrollment to the end of trial (2 sessions, 8 hours total per patient)
|
Evaluate the effect of the device on stair ascent and descent gait patterns.
Gait will be measured with a VICON motion capture system.
Unit of measure is gait symmetry.
|
From enrollment to the end of trial (2 sessions, 8 hours total per patient)
|
|
Effect of device on sloped ground walking gait
Time Frame: From enrollment to the end of trial (2 sessions, 8 hours total per patient)
|
Evaluate the effect of the device on sloped ground walking gait patterns.
Gait will be measured with a VICON motion capture system.
Unit of measure is gait symmetry.
|
From enrollment to the end of trial (2 sessions, 8 hours total per patient)
|
|
Effect of device on ground reaction force during ambulation
Time Frame: From enrollment to the end of trial (2 sessions, 8 hours total per patient)
|
Evaluate the effect of the device on ground reaction forces during ambulation.
Ground reaction forces will be measured with Bertec force plates.
Unit of measure is ground reaction force in Newtons.
|
From enrollment to the end of trial (2 sessions, 8 hours total per patient)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2306001029
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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