Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964855
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-25
First Post:
2023-07-11
Brief Title:
Comparison of Various Prosthetic Foot-Ankle Mechanisms
Sponsor:
Massachusetts Institute of Technology
Organization:
Massachusetts Institute of Technology
Study Overview
Official Title:
Comparison of Various Prosthetic Foot-Ankle Mechanisms
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In summary subjects will be asked to wear a number of sensors and use different ankle-foot prostheses in place of their customary prosthesis Data will be collected from the wearable sensors VICON motion capture system video cameras and force sensors in the ground as they walk on level-ground on a treadmill and on stairs The controller of any powered prosthesis will be electronically adjusted between trials or while the subject walks to determine how their gait changes in response to these changes Trials will also be conducted with a standard passive prosthesis that would be prescribed for a person of similar height and weight
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
Locations and Timeline
Experimental sessions will be conducted in the MIT Biomechatronics Laboratory E14-274 75 Amherst St Cambridge MA 02139 Any alignment and fitting of prosthetic devices will take place at A Step Ahead Prosthetics 21 A St Burlington MA 01803
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 After subject selection the entire study is expected to take 3 months
Powered Prosthesis
Subjects will be given two computer-controlled powered ankle-foot prostheses to attach in place of their customary prosthesis during a session These include the Blatchford Elan as well as a variable-stiffness prosthesis developed in the Biomechatronics lab These powered prostheses have the capability of providing active assistance or changing mechanical properties during walking Controls can 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 three passive prostheses to attach in place of your customary prosthesis during a session These include the Ossur Pro-flex XC a passive sliding-beam prosthesis and a passive prosthesis that can change ankle equilibrium angle manually 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 The first segment consists of level-ground walking on a treadmill at three speeds between 05-15ms slow to fast walking 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 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
The second session will consist of slope and stair walking Each subject will ascend and descend stairs and a ramp inclined between 4-10 from horizontal at their preferred speed in a randomly selected order 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 slope ambulation on an instrumented treadmill subjects will walk for a total of 2mins for slope ascent and 2mins for slope descent with each prosthesis For each slope and stair ascentdescent 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 ascentdescent trial resulting in three completed questionnaires for each subject
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
Locations and Timeline
Experimental sessions will be conducted in the MIT Biomechatronics Laboratory E14-274 75 Amherst St Cambridge MA 02139 Any alignment and fitting of prosthetic devices will take place at A Step Ahead Prosthetics 21 A St Burlington MA 01803
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 After subject selection the entire study is expected to take 3 months
Powered Prosthesis
Subjects will be given two computer-controlled powered ankle-foot prostheses to attach in place of their customary prosthesis during a session These include the Blatchford Elan as well as a variable-stiffness prosthesis developed in the Biomechatronics lab These powered prostheses have the capability of providing active assistance or changing mechanical properties during walking Controls can 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 three passive prostheses to attach in place of your customary prosthesis during a session These include the Ossur Pro-flex XC a passive sliding-beam prosthesis and a passive prosthesis that can change ankle equilibrium angle manually 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 The first segment consists of level-ground walking on a treadmill at three speeds between 05-15ms slow to fast walking 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 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
The second session will consist of slope and stair walking Each subject will ascend and descend stairs and a ramp inclined between 4-10 from horizontal at their preferred speed in a randomly selected order 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 slope ambulation on an instrumented treadmill subjects will walk for a total of 2mins for slope ascent and 2mins for slope descent with each prosthesis For each slope and stair ascentdescent 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 ascentdescent trial resulting in three completed questionnaires for each subject
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None