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

June 21, 2022 updated by: Kinex Medical Company, LLC

Randomized Study of the KinexConnect Telerehabilitation System Versus Outpatient Physical Therapy After Total Knee Arthroplasty

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

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

  • United States
    • Iowa
      • Des Moines, Iowa, United States, 50266
        • Des Moines Orthopedic Surgeons

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
1 year
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.
3 months
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months and 6 months
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 months and 6 months
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
3 months and 1 year
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.
3 months and 1 year
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.
3 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kinex Medical Company, LLC

Collaborators

Health Factors Inc

Investigators

  • Principal Investigator: Barron Bremner, DO, Des Moines Orthopedic Suregons

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

Helpful Links

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 (Actual)

November 1, 2019

Primary Completion (Anticipated)

October 31, 2022

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

December 4, 2019

First Submitted That Met QC Criteria

December 5, 2019

First Posted (Actual)

December 10, 2019

Study Record Updates

Last Update Posted (Actual)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 21, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KC-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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