Status:
COMPLETED
An Investigation of Functional Improvements in the RHEO KNEE Compared to Hydraulic Microprocessor Controlled Knees (MPKs)
Lead Sponsor:
Össur Iceland ehf
Collaborating Sponsors:
Baker Orthotics & Prosthetics
Virginia Prosthetics & Orthotics
Conditions:
Prosthesis User
Amputation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study was to evaluate the mobility, perceived safety and functioning of unilateral transfemoral (TF) amputees using the Rheo Knee XC compared to their existing prosthetic knee (RHEO KN...
Detailed Description
Recruiting and participants: A convenience sample of 15 transfemoral amputee users was recruited at 4 study sites. Potential subjects were identified from the customer base of study sites, local inve...
Eligibility Criteria
Inclusion
- Cognitive ability to understand all instructions and questionnaires in the study;
- Unilateral kneedisartic or transfemoral users fitted to Rheo Knee II,III Genium or X2 or X3
- Willing and able to participate in the study and follow the protocol
- Confident prosthetic users for more than 3 months
- Older than 18 years
Exclusion
- 50Kg\> body weight \> 136Kg
- Users with cognitive impairment
- Users not understanding the function of the knee
- Users not able to charge the battery
Key Trial Info
Start Date :
June 30 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 4 2015
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04023578
Start Date
June 30 2015
End Date
August 4 2015
Last Update
April 6 2020
Active Locations (4)
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1
Ossur Americas, Florida Gait lab
Orlando, Florida, United States, 32812
2
Methodist Rehabilitation Center
Flowood, Mississippi, United States, 39232
3
Baker Orthotics & Prosthetics
Fort Worth, Texas, United States, 76104
4
Virginia Prosthetics & Orthotics
Roanoke, Virginia, United States, 24012