- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02426190
Knee Arthroplasty Rehabilitation Outcomes Study (KAROS)
April 12, 2019 updated by: Jean Hsieh, PhD, MedStar National Rehabilitation Network
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
386
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- MedStar National Rehabilitation Network
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
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.
|
Discharge from outpatient rehabilitation (on average 2 months from baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michele Vita, DPT, MedStar National Rehabilitation Network
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hsieh CJ, DeJong G, Vita M, Zeymo A, Desale S. Effect of Outpatient Rehabilitation on Functional Mobility After Single Total Knee Arthroplasty: A Randomized Clinical Trial. JAMA Netw Open. 2020 Sep 1;3(9):e2016571. doi: 10.1001/jamanetworkopen.2020.16571.
- DeJong G, Hsieh CJ, Vita MT, Zeymo A, Boucher HR, Thakkar SC. Innovative Devices Did Not Provide Superior Total Knee Arthroplasty Outcomes in Post-Operative Rehabilitation: Results From a Four-Arm Randomized Clinical Trial. J Arthroplasty. 2020 Aug;35(8):2054-2065. doi: 10.1016/j.arth.2020.03.048. Epub 2020 Apr 2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 31, 2017
Study Registration Dates
First Submitted
April 8, 2015
First Submitted That Met QC Criteria
April 21, 2015
First Posted (Estimate)
April 24, 2015
Study Record Updates
Last Update Posted (Actual)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 12, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 2012-347
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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