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Completed

NCT Number: NCT03433300

Microprocessor Knees in Early Rehabilitation

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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Key information

Conditions

Amputation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ottobock Kenevo/C-Leg

Device

Microprocessor-controlled prosthetic knee

Ottobock 3R60/3R62

Device

Nonmicroprocessor-controlled knee

Primary outcomes

  1. Prosthetic Limb Users Survey of Mobility

    Time frame: Monthly for 3 months

    Self-reported prosthetic mobility

Secondary outcomes

  1. Fall frequency

    Time frame: Monthly for 3 months

    Number of falls while using the prosthesis

  2. Daily step count

    Time frame: Average daily step count by month for 3 months

    Walking activity measured with StepWatch Monitor

  3. Timed up and go

    Time frame: Monthly for 3 months

    Timed performance test that measures rising from a chair, walking 3m, and returning to a seated position.

  4. Amputee Mobility Predictor (AMPPro) Assessment Tool

    Time frame: Monthly for 3 months

    The name of this tool is the Amputee Mobility Predictor (AMPPro) and it was developed by Robert Gailey, PhD, PT (https://www.sralab.org/rehabilitation-measures/amputee-mobility-predictor-0). The AMPPro assesses performance-based mobility for people who use prosthetic limbs. Example items include standing balance, ability to vary cadence, and ability to step over an obstacle.

  5. Six-minute walk test

    Time frame: Monthly for 3 months

    Evaluates distance walked over 6 minute time frame with rest as needed

  6. Gait quality

    Time frame: Monthly for 3 months

    GaitRite System, pressure sensitive instrumented walkway will collect average walking speed, step width, step time asymmetry during 6 minute walk test

  7. Activities-Specific Balance Confidence Scale (ABC)

    Time frame: Baseline and monthly for 3 months

    The Activities-Specific Balance Confidence Scale (ABC) measures the construct of balance confidence. The 16-item ABC survey asks respondents to rate their confidence in performing a variety of activities without becoming unstable (e.g., walking in the home, walking on a ramp, walking in crowds). Response options range from "no confidence" to "completely confident" when performing the activity. The revised scale proposed by Sakakibara (2011) will be used to calculate a total balance confidence score; scores for participants will range from 0 (low balance confidence) to 4 (high balance confidence).

  8. Patient Reported Outcomes Measurement Information System 29-item profile (PROMIS-29) version 1.0

    Time frame: Baseline and monthly for 3 months

    Self-reported measure of Physical Function, satisfaction with social roles, fatigue, sleep disturbance, pain intensity, pain interference, anxiety and depression

  9. Reintegration to Normal Living Index (RNLI)

    Time frame: Baseline and monthly for 3 months

    11 item questionnaire to assess self-reported physical, social and psychologic performance following injury

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Otto Bock Healthcare Products GmbH
  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 14, 2018
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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