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

Transfemoral Amputation Clinical Trial

— OPK  

Official title:

Outcomes Associated With Use of Passive, Adaptive, and Active Prosthetic Knees in Persons With Unilateral, Transfemoral Amputation: a Randomized Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02219230
• Other study ID #: 40660-A
• Secondary ID: A62089
• Status: Completed
• Phase: N/A
• First received: July 29, 2014
• Last updated: December 23, 2015
• Start date: June 2011
• Est. completion date: September 2013

Study information

• Verified date: December 2015
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Transfemoral Amputation

Intervention

Device:
• Active knee (Ossur Power Knee II)
Prosthetic knee with active control system.
• Adaptive knee (Ossur Rheo)
Prosthetic knee with adaptive control system.
• Passive knee (Various manufacturers)
Prosthetic knee with mechanical control system.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Össur Ehf

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Secondary	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)
Secondary	Prosthesis Evaluation Questionnaire (PEQ)	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)
Secondary	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)
Secondary	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)

External Links

•   Study results published in the Journal of Rehabilitation Research and Development