Microprocessor Knees in Early Rehabilitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-13

Study Completion Date

2020-05-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Amputation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pilot randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Investigators who will conduct performance-based assessments will be blinded to the intervention.

Study Groups

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Microprocessor Knee

Ottobock Kenevo/Ottobock C-Leg

Group Type EXPERIMENTAL

Ottobock Kenevo/C-Leg

Intervention Type DEVICE

Microprocessor-controlled prosthetic knee

Nonmicroprocessor knee

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

Group Type ACTIVE_COMPARATOR

Ottobock 3R60/3R62

Intervention Type DEVICE

Nonmicroprocessor-controlled knee

Interventions

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Ottobock Kenevo/C-Leg

Microprocessor-controlled prosthetic knee

Intervention Type DEVICE

Ottobock 3R60/3R62

Nonmicroprocessor-controlled knee

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No