NCT03433300

Microprocessor Knees in Early Rehabilitation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amputation

Interventions

Type	Name	Description
DEVICE	Ottobock Kenevo/C-Leg	Microprocessor-controlled prosthetic knee
DEVICE	Ottobock 3R60/3R62	Nonmicroprocessor-controlled knee

Timeline

• Start date: 2018-04-13
• Primary completion: 2020-05-15
• Completion: 2020-05-15
• First posted: 2018-02-14
• Last updated: 2020-09-11

Locations

1 site across 1 country: United States