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Clinical Trials/NCT03433300
NCT03433300
Completed
N/A

Do Microprocessor Knees Improve Outcomes in Early Prosthetic Rehabilitation Compared to Nonmicroprocessor Knees?

University of Washington1 site in 1 country19 target enrollmentApril 13, 2018
ConditionsAmputation

Overview

Phase
N/A
Intervention
Not specified
Conditions
Amputation
Sponsor
University of Washington
Enrollment
19
Locations
1
Primary Endpoint
Prosthetic Limb Users Survey of Mobility
Status
Completed
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
April 13, 2018
End Date
May 15, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sara Morgan

Acting Assistant Professor, Department of Rehabilitation Medicine

University of Washington

Eligibility Criteria

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)

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)

Study Sites (1)

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