Clinical trial NCT03433300: Microprocessor Knees in Early Rehabilitation
Official title: Do Microprocessor Knees Improve Outcomes in Early Prosthetic Rehabilitation Compared to Nonmicroprocessor Knees?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Otto Bock Healthcare Products GmbH
First posted: 2018-02-14
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot randomized controlled trial
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Prosthetic Limb Users Survey of Mobility
timeFrame: Monthly for 3 months
Secondary outcomes:
measure: Fall frequency
timeFrame: Monthly for 3 months
measure: Daily step count
timeFrame: Average daily step count by month for 3 months
measure: Timed up and go
timeFrame: Monthly for 3 months
measure: Amputee Mobility Predictor (AMPPro) Assessment Tool
timeFrame: Monthly for 3 months
measure: Six-minute walk test
timeFrame: Monthly for 3 months
measure: Gait quality
timeFrame: Monthly for 3 months
measure: Activities-Specific Balance Confidence Scale (ABC)
timeFrame: Baseline and monthly for 3 months
measure: Patient Reported Outcomes Measurement Information System 29-item profile (PROMIS-29) version 1.0
timeFrame: Baseline and monthly for 3 months
measure: Reintegration to Normal Living Index (RNLI)
timeFrame: Baseline and monthly for 3 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Sara J Morgan, PhD
role: PRINCIPAL_INVESTIGATOR
References: