Study of the KinexConnect Telerehabilitation System (KCTRS)

Osteoarthritis, Knee Clinical Trial

— KCTRS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04191798
• Other study ID #: KC-07
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: April 30, 2023

Study information

• Verified date: June 2022
• Source: Kinex Medical Company, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 30, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Des Moines Orthopedic Surgeons	Des Moines	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Kinex Medical Company, LLC	Health Factors Inc

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

Buhagiar MA, Naylor JM, Harris IA, Xuan W, Kohler F, Wright R, Fortunato R. Effect of Inpatient Rehabilitation vs a Monitored Home-Based Program on Mobility in Patients With Total Knee Arthroplasty: The HIHO Randomized Clinical Trial. JAMA. 2017 Mar 14;31 — View Citation

Correia FD, Nogueira A, Magalhães I, Guimarães 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, — View Citation

Correia FD, Nogueira A, Magalhães I, Guimarães 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 Repla — View Citation

Fleischman AN, Crizer MP, Tarabichi M, Smith S, Rothman RH, Lonner JH, Chen AF. 2018 John N. Insall Award: Recovery of Knee Flexion With Unsupervised Home Exercise Is Not Inferior to Outpatient Physical Therapy After TKA: A Randomized Trial. Clin Orthop R — View 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. Review. — View 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. — View Citation

Moffet H, Tousignant M, Nadeau S, Mérette C, Boissy P, Corriveau H, Marquis F, Cabana F, Belzile ÉL, Ranger P, Dimentberg R. Patient Satisfaction with In-Home Telerehabilitation After Total Knee Arthroplasty: Results from a Randomized Controlled Trial. Te — View Citation

Moffet H, Tousignant M, Nadeau S, Mérette C, Boissy P, Corriveau H, Marquis F, Cabana F, Ranger P, Belzile ÉL, Dimentberg R. In-Home Telerehabilitation Compared with Face-to-Face Rehabilitation After Total Knee Arthroplasty: A Noninferiority Randomized Co — View 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. — View Citation

Pastora-Bernal JM, Martín-Valero R, Barón-López FJ, Estebanez-Pérez 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. Review. — View 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 201 — View 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. Review. — View Citation

Tousignant M, Moffet H, Nadeau S, Mérette C, Boissy P, Corriveau H, Marquis F, Cabana F, Ranger P, Belzile ÉL, Dimentberg R. Cost analysis of in-home telerehabilitation for post-knee arthroplasty. J Med Internet Res. 2015 Mar 31;17(3):e83. doi: 10.2196/jm — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Primary	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.	1 year
Primary	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.	3 months
Primary	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.	1 year
Secondary	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	3 months and 6 months
Secondary	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.	3 months and 6 months
Secondary	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	3 months and 1 year
Secondary	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.	3 months and 1 year
Secondary	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.	3 months and 1 year

External Links

•   SURGICAL MANAGEMENT OF OSTEOARTHRITIS OF THE KNEE EVIDENCE-BASED CLINICAL PRACTICE GUIDELINE
•   Virtual Exercise Rehabilitation In-Home Therapy: A Randomized Study (VERITAS)