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| Name | Class |
|---|---|
| Health Factors Inc | UNKNOWN |
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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KinexConnect | Experimental | Rehab at Home Patients |
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| Outpatient PT | Active Comparator | In-person PT patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telerehabilitation using the KinexConnect system for rehabilitation after TKA. | Behavioral | KinexConnect subjects are asked to Perform CPM therapy for 4 weeks. Perform a KCK home exercise program (HEP) for 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Passive Range of Motion (PRoM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barron Bremner, DO | Des Moines Orthopedic Suregons | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Des Moines Orthopedic Surgeons | Des Moines | Iowa | 50266 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28455277 | Background | 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. | |
| 26843466 | Background | 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. |
| Label | URL |
|---|---|
| SURGICAL MANAGEMENT OF OSTEOARTHRITIS OF THE KNEE EVIDENCE-BASED CLINICAL PRACTICE GUIDELINE | View source |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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All TUG and RoM assessments will be performed by trained physician assistants who will remain blinded to allocation throughout the study
| Traditional outpatient PT for rehabilitation after TKA. | Behavioral | 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. |
|
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) | 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) | 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 | 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 |
| 28027679 | Background | 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. |
| 30329126 | Background | 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. |
| 25765130 | Background | 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. |
| 30992236 | Result | 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. |
| 26940798 | Result | 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. |
| 26178888 | Result | 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. |
| 30050087 | Result | 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. |
| 30816849 | Result | 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. |
| 30794229 | Result | 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 Relat Res. 2019 Jan;477(1):60-69. doi: 10.1097/CORR.0000000000000561. |
| 27529575 | Result | Moffet H, Tousignant M, Nadeau S, Merette C, Boissy P, Corriveau H, Marquis F, Cabana F, Belzile EL, Ranger P, Dimentberg R. Patient Satisfaction with In-Home Telerehabilitation After Total Knee Arthroplasty: Results from a Randomized Controlled Trial. Telemed J E Health. 2017 Feb;23(2):80-87. doi: 10.1089/tmj.2016.0060. Epub 2016 Aug 16. |
| 25840501 | Result | Tousignant M, Moffet H, Nadeau S, Merette C, Boissy P, Corriveau H, Marquis F, Cabana F, Ranger P, Belzile EL, 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/jmir.3844. |
| 28291891 | Result | 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;317(10):1037-1046. doi: 10.1001/jama.2017.1224. |
| D012216 |
| Rheumatic Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |