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

NCT02219230 | Completed

• 2 other identifiers: 40660-AA62089
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Transfemoral Amputation

Outcome Measures

Primary Outcomes (5)

• 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)

Secondary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

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)

Device: Active knee (Ossur Power Knee II); Device: Adaptive knee (Ossur Rheo); Device: Passive knee (Various manufacturers)

Interventions

Active knee (Ossur Power Knee II) DEVICE

Prosthetic knee with active control system.

Also known as: Power knee, Motorized knee

Prosthetic knee

Adaptive knee (Ossur Rheo) DEVICE

Prosthetic knee with adaptive control system.

Also known as: Magnetorheological knee, Microprocessor knee

Prosthetic knee

Passive knee (Various manufacturers) DEVICE

Prosthetic knee with mechanical control system.

Also known as: Mechanical knee, Hydraulic knee, Pneumatic knee

Prosthetic knee

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Össur Iceland ehf: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related 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. doi: 10.1682/JRRD.2014.09.0210.

  PMID: 26560243 RESULT

Study Officials

• Brian Hafner, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: August 18, 2014
• Study Start: June 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 28, 2015

Record last verified: 2015-12

Locations

US (1)