Use of Passive, Adaptive, and Active Prosthetic Knees in Persons With Unilateral, Transfemoral Amputation

Not Applicable

Completed

• Conditions: Transfemoral Amputation

• Registration Number: NCT02219230
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Study First Submitted: 2014-07-29
• Study First Submitted QC: 2014-08-14
• Study First Posted: 2014-08-18
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-23
• Last Update Posted: 2015-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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)

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States