Clinical trial NCT02219230: Use of Passive, Adaptive, and Active Prosthetic Knees in Persons With Unilateral, Transfemoral Amputation
Official title: Outcomes Associated With Use of Passive, Adaptive, and Active Prosthetic Knees in Persons With Unilateral, Transfemoral Amputation: a Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transfemoral Amputation
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Össur Iceland ehf
First posted: 2014-08-18
Enrollment: 12
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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

Primary outcomes:
measure: Timed Up and Go
timeFrame: 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: Timed Ramp Test
timeFrame: 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: Timed Stair Test
timeFrame: 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: Step activity
timeFrame: 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: Obstacle course time
timeFrame: 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)
Secondary outcomes:
measure: Reported Falls
timeFrame: 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: Prosthesis Evaluation Questionnaire (PEQ)
timeFrame: 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: Activities Specific Balance Confidence Scale (ABC)
timeFrame: 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: Patient Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 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)
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Brian Hafner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.