ClinicalTrials.Veeva

Menu

Microprocessor Knees in Early Rehabilitation

University of Washington logo

University of Washington

Status

Completed

Conditions

Amputation

Treatments

Device: Ottobock Kenevo/C-Leg
Device: Ottobock 3R60/3R62

Study type

Interventional

Funder types

Other
Other U.S. Federal agency
Industry

Identifiers

NCT03433300
STUDY00003524

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

19 participants in 2 patient groups

Microprocessor Knee
Experimental group
Description:
Ottobock Kenevo/Ottobock C-Leg
Treatment:
Device: Ottobock Kenevo/C-Leg
Nonmicroprocessor knee
Active Comparator group
Description:
Ottobock 3R60 for K3 participants, Ottobock 3R62 for K2 participants.
Treatment:
Device: Ottobock 3R60/3R62

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems