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Completed

NCT Number: NCT02426190

Knee Arthroplasty Rehabilitation Outcomes Study

The objective of the KAROS study is to compare rehabilitation outcomes between 3 proposed protocols and a current standard of care protocol for the purpose of identifying better practice for outpatient rehabilitation among patients with single total knee replacement. The 3 advanced protocols involve use of an anti-gravity treadmill and/or the patterned electrical neuromuscular stimulation (PENS). Both medical modalities have been cleared by the FDA to be used in medical rehabilitation, including total knee replacement.

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Key information

Conditions

Total Knee Arthroplasty Rehabilitation

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MedStar National Rehabilitation Network

Washington D.C., District of Columbia, 20010, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who undergo an elective single total knee arthroplasty and initiate their outpatient rehabilitation therapy within 3 weeks after surgery.
  • Patients who are 40 years old or older.
  • Patients who weight less than 320 lb to accommodate the weight limit to use the anti-gravity treadmill.

Exclusion criteria

  • Patients who had any lower extremity joint replacement less than 1 year prior the current total knee replacement.
  • Patients who are pregnant or may be pregnant.
  • Patients who have a medical history of neurologic disorders.
  • Patients who have received more than 2 weeks of other formats of rehabilitation prior their outpatient rehabilitation program.
  • Patients who received any cancer treatment in the past year prior the current surgery.
  • Patients who have uncontrolled cardiovascular hypertension.
  • Patients who have cardiac demand pacemakers and/or implanted defibrillators.

Treatment and study plan

Anti-gravity treadmill

Other

The intervention is to ask study participants to ambulate using an anti-gravity treadmill that integrates patented, NASA Differential Air Pressure (DAP) technology -- a precise air calibration system -- to uniformly reduce gravitational load and body weight during the warm-up phase of an outpatient physical therapy following a single total knee replacement.

PENS - neuro-muscular stimulation

Other

The intervention is to ask study participants to warm up using Patterned Electrical Neuromuscular Stimulation (PENS) - that closely replicates the body's normal muscle and nerve firing patterns -- on his/her surgical leg in conjunction with a recumbent bike or a Nu-step bike during the warm-up phase of an outpatient physical therapy following a single total knee replacement.

Anti-gravity treadmill & PENS - neuro-muscular stimulation

Other

The intervention is to ask study participants to ambulate using an anti-gravity treadmill in conjunction with use of Patterned Electrical Neuromuscular Stimulation (PENS) during the warm-up phase of an outpatient physical therapy following a single total knee replacement.

Recumbent or Nu-step bike

Other

This is the active comparator of the trial that participants are asked to use either a recumbent or Nu-step bike normally seen in an outpatient physical therapy clinic to warm-up during a physical therapy session following a single total knee replacement.

Primary outcomes

  1. AM-PAC (Activity Measure for Post Acute Care) Basic Mobility score: Baseline

    Time frame: Baseline

    The primary outcome measure is the AM-PAC Basic Mobility score. AM-PAC is a patient-reported instrument to measure functional level in 3 domains: basic mobility, daily activity, and applied cognition. For the purpose of the study, only the basic mobility domain was measured. Using item-response theory, the AM-PAC program selects the most representative questions from its extensive item bank to ask when measuring a patient's functional level. This study used the AM-PAC basic mobility paper short form designed for outpatient settings. The short-form consists of 18 questions and produces a raw score (18 to 72) transformed into a score ranging from 29.41 to 80.30 based on item-degree of difficulty. Higher transformed scores denote higher functional mobility: 34 - 51.9 = limited indoor mobility; 52 - 65.9 = enhanced indoor mobility; 66 and above = outdoor mobility.

  2. AM-PAC (Activity Measure for Post Acute Care) Basic Mobility score: Discharge from outpatient rehabilitation

    Time frame: Discharge from outpatient rehabilitation (on average 2 months from baseline)

    The primary outcome measure is the AM-PAC Basic Mobility score upon discharge from outpatient therapy. AM-PAC is a patient-reported instrument to measure functional level in 3 domains: basic mobility, daily activity, and applied cognition. For the purpose of the study, only the basic mobility domain was measured. Using item-response theory, the AM-PAC program selects the most representative questions from its extensive item bank to ask when measuring a patient's functional level. This study used the AM-PAC basic mobility paper short form designed for outpatient settings. The short-form consists of 18 questions and produces a raw score (18 to 72) transformed into a score ranging from 29.41 to 80.30 based on item-degree of difficulty. Higher transformed scores denote higher functional mobility: 34 - 51.9 = limited indoor mobility; 52 - 65.9 = enhanced indoor mobility; 66 and above = outdoor mobility.

Sponsors and collaborators

Lead sponsor

MedStar National Rehabilitation Network

Other

Registry information

Acronym: KAROS

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 24, 2015
Registry last updated
Apr 16, 2019

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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