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

Primary Purpose

Osteoarthritis, Knee

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telerehabilitation using the KinexConnect system for rehabilitation after TKA.
Traditional outpatient PT for rehabilitation after TKA.
Sponsored by
Kinex Medical Company, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Arthroplasty, Knee Replacement, Rehab at home, Virtual PT, Remote Patient Monitoring, Patient Engagement, TKR, TKA

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Des Moines Orthopedic Surgeons

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

KinexConnect

Outpatient PT

Arm Description

Rehab at Home Patients

In-person PT patients

Outcomes

Primary Outcome Measures

Change in the Timed up and Go (TUG) Test score
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.
Change in the Timed up and Go (TUG) Test score
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.
Economic Benefit
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.
Economic Benefit
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

Change in Active Range of Motion (ARoM)
Active Range of Motion is the difference between the maximum Flexion and maximum Extension the patient is able to achieve with independent effort
Change in Passive Range of Motion (PRoM)
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.
Change in Pain as measured by the Verbal Descriptive Scale (VDS)
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
Change in the Knee Osteoarthritis Outcome Score (KOOS)
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.
Change in the New Knee Society Score (NKSS) - Patient Satisfaction and Expectation
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.

Full Information

First Posted
December 4, 2019
Last Updated
June 21, 2022
Sponsor
Kinex Medical Company, LLC
Collaborators
Health Factors Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04191798
Brief Title
Study of the KinexConnect Telerehabilitation System (KCTRS)
Acronym
KCTRS
Official Title
Randomized Study of the KinexConnect Telerehabilitation System Versus Outpatient Physical Therapy After Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kinex Medical Company, LLC
Collaborators
Health Factors Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Arthroplasty, Knee Replacement, Rehab at home, Virtual PT, Remote Patient Monitoring, Patient Engagement, TKR, TKA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
KinexConnect
Arm Type
Experimental
Arm Description
Rehab at Home Patients
Arm Title
Outpatient PT
Arm Type
Active Comparator
Arm Description
In-person PT patients
Intervention Type
Behavioral
Intervention Name(s)
Telerehabilitation using the KinexConnect system for rehabilitation after TKA.
Intervention Description
KinexConnect subjects are asked to Perform CPM therapy for 4 weeks. Perform a KCK home exercise program (HEP) for 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Traditional outpatient PT for rehabilitation after TKA.
Intervention Description
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 Measure Information:
Title
Change in the Timed up and Go (TUG) Test score
Description
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.
Time Frame
3 months
Title
Change in the Timed up and Go (TUG) Test score
Description
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.
Time Frame
1 year
Title
Economic Benefit
Description
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.
Time Frame
3 months
Title
Economic Benefit
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in Active Range of Motion (ARoM)
Description
Active Range of Motion is the difference between the maximum Flexion and maximum Extension the patient is able to achieve with independent effort
Time Frame
3 months and 6 months
Title
Change in Passive Range of Motion (PRoM)
Description
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.
Time Frame
3 months and 6 months
Title
Change in Pain as measured by the Verbal Descriptive Scale (VDS)
Description
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
Time Frame
3 months and 1 year
Title
Change in the Knee Osteoarthritis Outcome Score (KOOS)
Description
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.
Time Frame
3 months and 1 year
Title
Change in the New Knee Society Score (NKSS) - Patient Satisfaction and Expectation
Description
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.
Time Frame
3 months and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Planned for a primary unilateral TKA. At least 21 years of age. Capable of understanding the study requirements and giving written informed consent. Willing and able to comply with either therapy program. Has easy access to caregiver support. Exclusion Criteria: Active range-of-motion (ARoM) < 80 degrees in target knee. Unable to read and write in English. Lack of email capability to receive recovery trend information. Previous knee intervention in target knee. Previous knee joint infection in either knee. Received a revision TKA (opposite knee). Planned for bilateral TKA. Self-reported pregnancy. Reason for arthroplasty being for the treatment of fracture, infection or malignancy. Other physical or mental impairments or medical conditions that may affect ability to complete therapy as prescribed. Unwilling to participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barron Bremner, DO
Organizational Affiliation
Des Moines Orthopedic Suregons
Official's Role
Principal Investigator
Facility Information:
Facility Name
Des Moines Orthopedic Surgeons
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28455277
Citation
Pastora-Bernal JM, Martin-Valero R, Baron-Lopez FJ, Estebanez-Perez MJ. Evidence of Benefit of Telerehabitation After Orthopedic Surgery: A Systematic Review. J Med Internet Res. 2017 Apr 28;19(4):e142. doi: 10.2196/jmir.6836.
Results Reference
background
PubMed Identifier
26843466
Citation
Shukla H, Nair SR, Thakker D. Role of telerehabilitation in patients following total knee arthroplasty: Evidence from a systematic literature review and meta-analysis. J Telemed Telecare. 2017 Feb;23(2):339-346. doi: 10.1177/1357633X16628996. Epub 2016 Jul 9.
Results Reference
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PubMed Identifier
28027679
Citation
Jiang S, Xiang J, Gao X, Guo K, Liu B. The comparison of telerehabilitation and face-to-face rehabilitation after total knee arthroplasty: A systematic review and meta-analysis. J Telemed Telecare. 2018 May;24(4):257-262. doi: 10.1177/1357633X16686748. Epub 2016 Dec 27.
Results Reference
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PubMed Identifier
30329126
Citation
Kline PW, Melanson EL, Sullivan WJ, Blatchford PJ, Miller MJ, Stevens-Lapsley JE, Christiansen CL. Improving Physical Activity Through Adjunct Telerehabilitation Following Total Knee Arthroplasty: Randomized Controlled Trial Protocol. Phys Ther. 2019 Jan 1;99(1):37-45. doi: 10.1093/ptj/pzy119.
Results Reference
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PubMed Identifier
25765130
Citation
Ong KL, Lotke PA, Lau E, Manley MT, Kurtz SM. Prevalence and Costs of Rehabilitation and Physical Therapy After Primary TJA. J Arthroplasty. 2015 Jul;30(7):1121-6. doi: 10.1016/j.arth.2015.02.030. Epub 2015 Feb 28.
Results Reference
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PubMed Identifier
30992236
Citation
Rondon AJ, Phillips JLH, Fillingham YA, Gorica Z, Austin MS, Courtney PM. Bundled Payments Are Effective in Reducing Costs Following Bilateral Total Joint Arthroplasty. J Arthroplasty. 2019 Jul;34(7):1317-1321.e2. doi: 10.1016/j.arth.2019.03.041. Epub 2019 Mar 28.
Results Reference
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PubMed Identifier
26940798
Citation
Bini SA, Mahajan J. Clinical outcomes of remote asynchronous telerehabilitation are equivalent to traditional therapy following total knee arthroplasty: A randomized control study. J Telemed Telecare. 2017 Feb;23(2):239-247. doi: 10.1177/1357633X16634518. Epub 2016 Jul 9.
Results Reference
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PubMed Identifier
26178888
Citation
Moffet H, Tousignant M, Nadeau S, Merette C, Boissy P, Corriveau H, Marquis F, Cabana F, Ranger P, Belzile EL, Dimentberg R. In-Home Telerehabilitation Compared with Face-to-Face Rehabilitation After Total Knee Arthroplasty: A Noninferiority Randomized Controlled Trial. J Bone Joint Surg Am. 2015 Jul 15;97(14):1129-41. doi: 10.2106/JBJS.N.01066.
Results Reference
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Citation
Correia FD, Nogueira A, Magalhaes I, Guimaraes J, Moreira M, Barradas I, Teixeira L, Tulha J, Seabra R, Lains J, Bento V. Home-based Rehabilitation With A Novel Digital Biofeedback System versus Conventional In-person Rehabilitation after Total Knee Replacement: a feasibility study. Sci Rep. 2018 Jul 26;8(1):11299. doi: 10.1038/s41598-018-29668-0.
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Citation
Correia FD, Nogueira A, Magalhaes I, Guimaraes J, Moreira M, Barradas I, Molinos M, Teixeira L, Tulha J, Seabra R, Lains J, Bento V. Medium-Term Outcomes of Digital Versus Conventional Home-Based Rehabilitation After Total Knee Arthroplasty: Prospective, Parallel-Group Feasibility Study. JMIR Rehabil Assist Technol. 2019 Feb 28;6(1):e13111. doi: 10.2196/13111.
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Links:
URL
http://www.orthoguidelines.org/topic?id=1019
Description
SURGICAL MANAGEMENT OF OSTEOARTHRITIS OF THE KNEE EVIDENCE-BASED CLINICAL PRACTICE GUIDELINE

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Study of the KinexConnect Telerehabilitation System (KCTRS)

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