Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis
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|ClinicalTrials.gov Identifier: NCT01473992|
Recruitment Status : Completed
First Posted : November 17, 2011
Results First Posted : November 18, 2014
Last Update Posted : November 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Other and Unspecified Complications of Amputation Stump||Device: Otto Bock C-Leg Device: Otto Bock Genium||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Active Comparator: Prosthetic knee 1 (Otto Bock C-Leg)
This arm included unilateral transfemoral amputees who were assessed while using their preferred knee at study start(C-Leg). The Otto Bock C-Leg is a microprocessor knee using 2 sensors (1 for kinetics and 1 for kinematics).
Device: Otto Bock C-Leg
Amputees' preferred prosthetic knee.
Active Comparator: Prosthetic knee 2 (Otto Bock Genium)
This arm included unilateral transfemoral amputees who were assessed while using the experimental/study knee, the Genium. The Otto Bock Genium is a microprocessor knee using multiple sensors that hypothetically increase mobility functions (e.g. walking backwards, intuitive stance)
Device: Otto Bock Genium
No Intervention: Non-amputee controls
This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.
- 75 Meter Self Selected Walking Test [ Time Frame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation. ]Time to Complete a 75 meter walking distance.
- Physical Functional Performance (Continuous Scale; 10-items) [ Time Frame: Accommodation with knee systems is approximately 90 days. This test takes less than 1hr to complete. ]Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function.
- Balance and Stability [ Time Frame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation. ]Balance and stability will be assessed for limits of stability using the Biodex SD. The limit of stability score is a scaled score with a possible range of 0 (worst possible outcome) to 100 (best possible outcome)based on variability of the trajectory of the center of mass while weight shifting on a force platform.
- Prosthesis Evaluation Questionnaire: Utility Score. [ Time Frame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation. ]The Prosthetics Evaluation Questionnaire (PEQ) was used as a validated survey to solicit participants' subjective experience and feedback regarding prosthesis-related function and quality of life. PEQ domains are ordinally scaled from 0 (worst or most negative feeling/response) to 7 (best or most positive feeling/response).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01473992
|United States, Florida|
|University of South Florida|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||M. Jason Highsmith, PT,DPT,CP||University of South Florida|