Transfemoral Amputation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEActive knee (Ossur Power Knee II)
Prosthetic knee with active control system.
DEVICEAdaptive knee (Ossur Rheo)
Prosthetic knee with adaptive control system.
DEVICEPassive knee (Various manufacturers)
Prosthetic knee with mechanical control system.
Sponsors
Össur Iceland ehf
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* age 45 - 75 * body weight less than 275lbs * unilateral amputation between the hip and knee * amputation due to non-vascular causes * no other major limb amputations * amputation occurred at least 2 years prior * stable limb volume (i.e., at least 6 months on an unmodified prosthetic socket) * intact skin tissue without open wounds or sores for at least 2 months * physiologically stable medical condition (i.e., non-degenerative) * possession and regular (i.e., daily) use of a prosthesis with a prosthetic knee with non-microprocessor (i.e., mechanical or fluid) stance control * Medicare functional classification level (MFCL or K-level) 3
Exclusion criteria
* expect to receive or are expected to require a replacement prosthetic socket within 15 months * complete reliance on an assistive device (i.e., cane or walker) for ambulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Obstacle course time | 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) | Time to walk a 1/2-mile outdoor walking course. |
| Timed Up and Go | 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 performance test that measures rising from a chair, walking 3m, and returning to a seated position. |
| Timed Ramp Test | 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 performance test that involves walking up and down a 14ft ramp. |
| Timed Stair Test | 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 performance test that involves walking up and down 6 steps. |
| Step activity | 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) | Average daily step counts measured by an accelerometer-based device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prosthesis Evaluation Questionnaire (PEQ) | 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) | Self-report computerized survey (12 questions) |
| Activities Specific Balance Confidence Scale (ABC) | 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) | Self-report computerized survey (18 questions). |
| Patient Reported Outcomes Measurement Information System (PROMIS) | 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) | Self-report computerized questionnaire with 8-14 questions per domain. Includes Physical Function, Fatigue, and General Health subdomains. |
| Reported Falls | 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) | Self-report phone survey. |
Countries
United States
Outcome results
None listed