Do Microprocessor Knees Improve Outcomes in Early Prosthetic Rehabilitation Compared to Nonmicroprocessor Knees?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Washington
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Prosthetic Limb Users Survey of Mobility
Study Overview
Brief Summary
High-quality, empirical evidence to guide prosthetic rehabilitation following amputation ensures that Service members, Veterans, and civilians who experience limb loss have the potential to receive the highest quality care, regain mobility, return to gainful employment, and reintegrate into their communities. However, evidence to inform prosthetic care during the crucial post-amputation period is extremely limited. The proposed research will address this gap in knowledge by evaluating functional and patient-centered health outcomes associated with use of two distinct prosthetic knee technologies in early rehabilitation following transfemoral amputation. This novel, comparative effectiveness research aligns with the Prosthetic Outcomes Research Award (PORA) focus area of understanding the management of patient rehabilitation strategies throughout the rehabilitation process following neuromuscular injury.
The long-term goals of this project are to optimize early rehabilitation processes and associated outcomes for Service members, Veterans, and civilians with lower limb amputation. The purpose of this study is to evaluate the potential for different prosthetic knee technologies to promote function, health, and quality of life following amputation. A pilot randomized controlled trial will be conducted to compare falls, step activity, balance confidence, mobility, health-related quality of life, and community integration of people with recent transfemoral amputation in two prosthetic knee conditions: a microprocessor knee (MPK) with control of stance phase and a non-microprocessor knee (NMPK) that is appropriate for people in early rehabilitation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Investigators who will conduct performance-based assessments will be blinded to the intervention.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years of age or older, Unilateral transfemoral amputation, Between 4-16 weeks post amputation, Deemed ready for prosthetic fitting by a physician, No current or prior transfemoral prosthetic use, Able to read, write and communicate in English, Weight 125kg (275lbs) or less
Exclusion Criteria
- •Diagnosis of health condition (i.e. advanced cardiac disease, severe or end-stage pulmonary disease or severe dementia) that prevents safe prosthesis use or community ambulation with prosthesis, Weight greater than 125kg (275lbs)
Arms & Interventions
Microprocessor Knee
Ottobock Kenevo/Ottobock C-Leg
Intervention: Ottobock Kenevo/C-Leg (Device)
Nonmicroprocessor knee
Ottobock 3R60 for K3 participants, Ottobock 3R62 for K2 participants.
Intervention: Ottobock 3R60/3R62 (Device)
Outcomes
Primary Outcomes
Prosthetic Limb Users Survey of Mobility
Time Frame: Monthly for 3 months
Self-reported prosthetic mobility
Secondary Outcomes
- Amputee Mobility Predictor (AMPPro) Assessment Tool(Monthly for 3 months)
- Six-minute walk test(Monthly for 3 months)
- Fall frequency(Monthly for 3 months)
- Daily step count(Average daily step count by month for 3 months)
- Timed up and go(Monthly for 3 months)
- Gait quality(Monthly for 3 months)
- Activities-Specific Balance Confidence Scale (ABC)(Baseline and monthly for 3 months)
- Patient Reported Outcomes Measurement Information System 29-item profile (PROMIS-29) version 1.0(Baseline and monthly for 3 months)
- Reintegration to Normal Living Index (RNLI)(Baseline and monthly for 3 months)
Investigators
Sara Morgan
Acting Assistant Professor, Department of Rehabilitation Medicine
University of Washington