Microprocessor Knees in Early Rehabilitation

NCT03433300 | Completed

• 1 other identifier: STUDY00003524
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation

Outcome Measures

Primary Outcomes (1)

• Prosthetic Limb Users Survey of Mobility

  Self-reported prosthetic mobility

  Monthly for 3 months

Secondary Outcomes (9)

• 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

• Amputee Mobility Predictor (AMPPro) Assessment Tool

  Monthly for 3 months

• Six-minute walk test

  Monthly for 3 months

Study Arms (2)

Microprocessor Knee

EXPERIMENTAL

Ottobock Kenevo/Ottobock C-Leg

Device: Ottobock Kenevo/C-Leg

Nonmicroprocessor knee

ACTIVE COMPARATOR

Ottobock 3R60 for K3 participants, Ottobock 3R62 for K2 participants.

Device: Ottobock 3R60/3R62

Interventions

Ottobock Kenevo/C-Leg DEVICE

Microprocessor-controlled prosthetic knee

Microprocessor Knee

Ottobock 3R60/3R62 DEVICE

Nonmicroprocessor-controlled knee

Nonmicroprocessor knee

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Washington: lead
• United States Department of Defense: collaborator
• Otto Bock Healthcare Products GmbH: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Study Officials

• Sara J Morgan, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Investigators who will conduct performance-based assessments will be blinded to the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acting Assistant Professor, Department of Rehabilitation Medicine

Model Details: Pilot randomized controlled trial

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 14, 2018
• Study Start: April 13, 2018
• Primary Completion: May 15, 2020
• Study Completion: May 15, 2020
• Last Updated: September 11, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)