Ignite Creation Date:
2024-05-06 @ 3:49 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02383446
Status:
COMPLETED
Last Update Posted:
2016-01-22
First Post:
2015-02-25
Brief Title:
Efficiency of Hydraulic Microprocessor Prosthetic Foot for Traumatic Transtibial Amputees
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
Evaluation of the Efficiency of Hydraulic Microprocessor Prosthetic Foot for Traumatic Transtibial Amputees
Status:
COMPLETED
Status Verified Date:
2016-01
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:
Background
Trauma is the second most common factor for transtibial amputations just after vascular background Traumatic amputees generally function better than amputees due to vascular background The type of prosthetic foot fitted to the patient depends on his mobility and functional level and significantly influences his stability and gait symmetry A prosthetic foot with a hydraulic ankle provides significant advantages for high level functioning amputees decrease of loads in the residuum improvement in symmetry and generally gait pattern that is closer to natural The hydraulic prosthetic foot has recently been upgraded to include computerized control over the ankle movement using input from an array of sensors inside the foot Studies have demonstrated decrease in energy consumption and gait pattern that is more similar to healthy people However hydraulic feet with and without computer control have not been compared Furthermore the effects of a computerized foot on various important factors have not been investigated yet eg loads in the residuum the movement of the center of pressure and the patients satisfaction
Research objectives
To compare between hydraulic prosthetic feet with and without computerized control The comparison will be made while walking on flat or inclined surfaces positive or negative inclination Differences in gait parameters loads inside the residuum center of mass movement and patients satisfaction will be quantified
Research hypothesis Using a computerized prosthetic foot will provide better mobility performances improved gait factors and center of pressure movement decrease internal loads in the residuum and increase patients satisfaction
Research design
Clinical controlled research with research groupamputees and control group healthy
Trauma is the second most common factor for transtibial amputations just after vascular background Traumatic amputees generally function better than amputees due to vascular background The type of prosthetic foot fitted to the patient depends on his mobility and functional level and significantly influences his stability and gait symmetry A prosthetic foot with a hydraulic ankle provides significant advantages for high level functioning amputees decrease of loads in the residuum improvement in symmetry and generally gait pattern that is closer to natural The hydraulic prosthetic foot has recently been upgraded to include computerized control over the ankle movement using input from an array of sensors inside the foot Studies have demonstrated decrease in energy consumption and gait pattern that is more similar to healthy people However hydraulic feet with and without computer control have not been compared Furthermore the effects of a computerized foot on various important factors have not been investigated yet eg loads in the residuum the movement of the center of pressure and the patients satisfaction
Research objectives
To compare between hydraulic prosthetic feet with and without computerized control The comparison will be made while walking on flat or inclined surfaces positive or negative inclination Differences in gait parameters loads inside the residuum center of mass movement and patients satisfaction will be quantified
Research hypothesis Using a computerized prosthetic foot will provide better mobility performances improved gait factors and center of pressure movement decrease internal loads in the residuum and increase patients satisfaction
Research design
Clinical controlled research with research groupamputees and control group healthy
Detailed Description:
The research group will perform a gait analysis test on a computerized treadmill using their own non-computerized hydraulic foot while in-socket pressures are measured The prosthetic foot will then be replaced by a computerized prosthetic foot for one month following which the measurements will be repeated Gait factors will be examined spatio-temporal data center of pressure movement and internal loads inside the residuum will be evaluated Comparison will also include patients satisfaction and his ability to move around evaluated by dedicated questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None