Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Knee Arthroplasty Rehabilitation Outcomes Study (KAROS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02426190
Recruitment Status : Completed
First Posted : April 24, 2015
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Jean Hsieh, PhD, MedStar National Rehabilitation Network

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Rehabilitation Other: Anti-gravity treadmill Other: PENS - neuro-muscular stimulation Other: Anti-gravity treadmill & PENS - neuro-muscular stimulation Other: Recumbent or Nu-step bike Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 386 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Knee Arthroplasty Rehabilitation Outcomes Study
Study Start Date : October 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm 1
Patients in Arm 1 receive standard of care rehabilitation protocol using a recumbent or Nu-step bike during warm-up, followed by individualized therapeutic exercise, and cool-down protocols. The warm-up phase in the study refers to therapeutic exercise. The therapeutic exercise aims to condition and prepare patients for subsequent functional or therapeutic activities. The active comparator (Arm 1) is to ask participants to use modalities, such as a recumbent bike or a Nu-step bike during the warm-up phase of an outpatient physical therapy following a single total knee replacement.
Other: Recumbent or Nu-step bike
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.

Experimental: Arm 2
Patients in Arm 2 will use an anti-gravity treadmill (AlterG) during warm-up, followed by individualized therapeutic exercise and cool-down protocols.
Other: Anti-gravity treadmill
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.

Experimental: Arm 3
Patients in Arm 3 will use a recumbent or Nu-step bike along with the PENS neuromuscular stimulation modality during warm-up, followed by individualized therapeutic exercise and cool-down protocols.
Other: PENS - neuro-muscular stimulation
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.

Experimental: Arm 4
Patients in Arm 4 will use both an anti-gravity treadmill (AlterG) and the PENS neuromuscular stimulation modality during warm-up, followed by individualized therapeutic exercise and cool-down protocols.
Other: Anti-gravity treadmill & PENS - neuro-muscular stimulation
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.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426190


Locations
Layout table for location information
United States, District of Columbia
MedStar National Rehabilitation Network
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
MedStar National Rehabilitation Network
Investigators
Layout table for investigator information
Principal Investigator: Michele Vita, DPT MedStar National Rehabilitation Network
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jean Hsieh, PhD, Senior Research Associate, MedStar National Rehabilitation Network
ClinicalTrials.gov Identifier: NCT02426190    
Other Study ID Numbers: 2012-347
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019