Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| A62089 | Other Identifier | University of Washington |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Össur Iceland ehf | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goals of this study are to assess measured, observed, and self-reported outcomes achieved through the use of passive (mechanical), active(motorized) and adaptive (magnetorheological) prosthetic knee control systems in individuals with unilateral, transfemoral amputation.
An interrupted time-series trial with pre/post baseline assessments, randomized crossover of interventions, and within-phase repeated measures is used to evaluate and compare the effectiveness of the Össur Power Knee II and the Össur Rheo Knee in individuals with unilateral, transfemoral amputation. A rigorous and clinically-meaningful experimental protocol is applied to verify study participants receive appropriate training, experience, and assessment in each knee condition. A suite of standardized and ad-hoc physical performance tests, patient-reported questionnaires, and monitoring technologies were carefully selected to assess important, clinically-relevant participant outcomes. Comparative effectiveness of three prosthetic knee interventions are evaluated using direct measurement (i.e., timed tests), observed clinical ratings (i.e., subjective assessments of gait quality) and self-report instruments (i.e., health status surveys). Analyses will focus on identifying differences between control system technologies inherent to each type of prosthetic knee (i.e., passive [mechanical], adaptive [magnetorheological], and active [power]). Outcomes will be used to establish recommendations for which activities and patients knees are most appropriate or likely to produce a desired effect.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prosthetic knee | Experimental | Subjects crossed over between interventions (three different prosthetic knees). Knee conditions include 1) Active knee (Ossur Power Knee II); 2) Adaptive knee (Ossur Rheo); and 3) Passive knee (Various manufacturers) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active knee (Ossur Power Knee II) | Device | Prosthetic knee with active control system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Timed Up and Go | Timed performance test that measures rising from a chair, walking 3m, and returning to a seated position. | Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28) |
| Timed Ramp Test | Timed performance test that involves walking up and down a 14ft ramp. | Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28) |
| Timed Stair Test | Timed performance test that involves walking up and down 6 steps. | Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28) |
| Step activity | Average daily step counts measured by an accelerometer-based device. | Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28) |
| Obstacle course time | Time to walk a 1/2-mile outdoor walking course. | Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Reported Falls | Self-report phone survey. | Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28) |
| Prosthesis Evaluation Questionnaire (PEQ) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian Hafner, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26560243 | Result | Hafner BJ, Askew RL. Physical performance and self-report outcomes associated with use of passive, adaptive, and active prosthetic knees in persons with unilateral, transfemoral amputation: Randomized crossover trial. J Rehabil Res Dev. 2015;52(6):677-700. doi: 10.1682/JRRD.2014.09.0210. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 26, 2017 | |
| Reset | May 5, 2017 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Adaptive knee (Ossur Rheo) | Device | Prosthetic knee with adaptive control system. |
|
|
| Passive knee (Various manufacturers) | Device | Prosthetic knee with mechanical control system. |
|
|
Self-report computerized survey (12 questions)
| Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28) |
| Activities Specific Balance Confidence Scale (ABC) | Self-report computerized survey (18 questions). | Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28) |
| Patient Reported Outcomes Measurement Information System (PROMIS) | Self-report computerized questionnaire with 8-14 questions per domain. Includes Physical Function, Fatigue, and General Health subdomains. | Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28) |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 26, 2017 | May 5, 2017 |