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Study of the KinexConnect Telerehabilitation System (KCTRS) (KCTRS)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04191798
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : December 11, 2019
Sponsor:
Collaborator:
Health Factors Inc
Information provided by (Responsible Party):
Kinex Medical Company, LLC

Brief Summary:
A randomized, single-blind study comparing telerehabilitation at home with continuous passive motion (CPM) and a tablet-based patient engagement application (KinexConnect) versus traditional outpatient physical therapy (PT) following total knee arthroplasty (TKA).

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Behavioral: Telerehabilitation using the KinexConnect system for rehabilitation after TKA. Behavioral: Traditional outpatient PT for rehabilitation after TKA. Not Applicable

Detailed Description:
The Randomized Study of the KinexConnect Telerehabilitation System is a 1:1 randomized, single-blind, prospective cohort study to be conducted at one investigational site in the United States. The study compares at-home telerehabilitation system versus traditional outpatient PT following total knee arthroplasty (TKA). The telerehabilitation system involves a tablet-enabled patient engagement application, the KinexConnect App, to be used in conjunction with a continuous passive motion (CPM) machine.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: All TUG and RoM assessments will be performed by trained physician assistants who will remain blinded to allocation throughout the study
Primary Purpose: Treatment
Official Title: Randomized Study of the KinexConnect Telerehabilitation System Versus Outpatient Physical Therapy After Total Knee Arthroplasty
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : July 22, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: KinexConnect
Rehab at Home Patients
Behavioral: Telerehabilitation using the KinexConnect system for rehabilitation after TKA.
KinexConnect subjects are asked to Perform CPM therapy for 4 weeks. Perform a KCK home exercise program (HEP) for 6 weeks.

Active Comparator: Outpatient PT
In-person PT patients
Behavioral: Traditional outpatient PT for rehabilitation after TKA.
Control subjects are asked to undergo standard outpatient physical therapy (PT) with a licensed physical therapist plus supplemental home exercises as directed. Nominally patients are expected to have 3 PT sessions per week for 4 weeks.




Primary Outcome Measures :
  1. Change in the Timed up and Go (TUG) Test score [ Time Frame: 3 months ]
    The TUG score is the measurement of time for a person to rise from a standard armchair (seat height 46 cm), walk 3 meters, turn, walk back to the chair, and sit down as quickly as possible. The mean scores for patients in both arms are derived and compared against each other. Closer the trial arm mean is to the control arm mean, the better.

  2. Change in the Timed up and Go (TUG) Test score [ Time Frame: 1 year ]
    The TUG score is the measurement of time for a person to rise from a standard armchair (seat height 46 cm), walk 3 meters, turn, walk back to the chair, and sit down as quickly as possible. The mean scores for patients in both arms are derived and compared against each other. Closer the trial arm mean is to the control arm mean, the better.

  3. Economic Benefit [ Time Frame: 3 months ]
    Expenses associated with rehabilitation after surgery will be based on costs associated with CPM rental fees and outpatient physical therapy visits. Estimates will be applied wherever actual expense data is not available.

  4. Economic Benefit [ Time Frame: 1 year ]
    Expenses associated with rehabilitation after surgery will be based on costs associated with CPM rental fees and outpatient physical therapy visits. Estimates will be applied wherever actual expense data is not available.


Secondary Outcome Measures :
  1. Change in Active Range of Motion (ARoM) [ Time Frame: 3 months and 6 months ]
    Active Range of Motion is the difference between the maximum Flexion and maximum Extension the patient is able to achieve with independent effort

  2. Change in Passive Range of Motion (PRoM) [ Time Frame: 3 months and 6 months ]
    Passive Range of Motion is the difference between the maximum Flexion and maximum Extension the patient is able to achieve when bearable force is exerted by the clinician.

  3. Change in Pain as measured by the Verbal Descriptive Scale (VDS) [ Time Frame: 3 months and 1 year ]

    This is a self reported outcome by the patient based on their expression of pain at a given time point when presented with the 7 verbal cues.

    The levels of pain reported vary from "No Pain" to "Most Intense Pain Imaginable". Higher the intensity of pain, worse the outcome


  4. Change in the Knee Osteoarthritis Outcome Score (KOOS) [ Time Frame: 3 months and 1 year ]

    The KOOS is a standardized and validated patient outcome score that assess functional limitation in patient with knee osteoarthritis. The survey questionnaire is filled out in its entirety by the patient.

    The five patient-relevant subscales of KOOS are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.


  5. Change in the New Knee Society Score (NKSS) - Patient Satisfaction and Expectation [ Time Frame: 3 months and 1 year ]

    The patient satisfaction and patient expectation scores are calculated by having the relevant sections of the survey questionnaire is filled out in its entirety by the patient.

    Patient Satisfaction is scored 0 - 40 points and Patient Expectation is scored 0 -15 points. with Zero being the worst outcome.




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.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Planned for a primary unilateral TKA.
  2. At least 21 years of age.
  3. Capable of understanding the study requirements and giving written informed consent.
  4. Willing and able to comply with either therapy program.
  5. Has easy access to caregiver support.

Exclusion Criteria:

  1. Active range-of-motion (ARoM) < 80 degrees in target knee.
  2. Unable to read and write in English.
  3. Lack of email capability to receive recovery trend information.
  4. Previous knee intervention in target knee.
  5. Previous knee joint infection in either knee.
  6. Received a revision TKA (opposite knee).
  7. Planned for bilateral TKA.
  8. Self-reported pregnancy.
  9. Reason for arthroplasty being for the treatment of fracture, infection or malignancy.
  10. Other physical or mental impairments or medical conditions that may affect ability to complete therapy as prescribed.
  11. Unwilling to participate.

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): NCT04191798


Contacts
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Contact: Ram Rajagopalan, MS, MBA 6515050501 ram.rajagopalan@healthfactorsinc.com
Contact: Dan Spors 6515050501 dan.spors@healthfactorsinc.com

Locations
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United States, Iowa
Des Moines Orthopedic Surgeons Recruiting
Des Moines, Iowa, United States, 50266
Contact: Amy Knight, CST    515-224-1414    aknight@dmos.com   
Contact: Barron Bremner, DO    5152241414    bbremner@dmos.com   
Sub-Investigator: Devon Goetz, MD         
Sponsors and Collaborators
Kinex Medical Company, LLC
Health Factors Inc
Investigators
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Principal Investigator: Barron Bremner, DO Des Moines Orthopedic Suregons

Additional Information:
Publications of Results:

Other Publications:
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Responsible Party: Kinex Medical Company, LLC
ClinicalTrials.gov Identifier: NCT04191798    
Other Study ID Numbers: KC-07
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kinex Medical Company, LLC:
Arthroplasty
Knee Replacement
Rehab at home
Virtual PT
Remote Patient Monitoring
Patient Engagement
TKR
TKA
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases