Study of the KinexConnect Telerehabilitation System (KCTRS)
KCTRS
Randomized Study of the KinexConnect Telerehabilitation System Versus Outpatient Physical Therapy After Total Knee Arthroplasty
1 other identifier
interventional
60
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2019
CompletedFirst Submitted
Initial submission to the registry
December 4, 2019
CompletedFirst Posted
Study publicly available on registry
December 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedJune 22, 2022
June 1, 2022
3 years
December 4, 2019
June 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Secondary Outcomes (5)
Change in Active Range of Motion (ARoM)
3 months and 6 months
Change in Passive Range of Motion (PRoM)
3 months and 6 months
Change in Pain as measured by the Verbal Descriptive Scale (VDS)
3 months and 1 year
Change in the Knee Osteoarthritis Outcome Score (KOOS)
3 months and 1 year
Change in the New Knee Society Score (NKSS) - Patient Satisfaction and Expectation
3 months and 1 year
Study Arms (2)
KinexConnect
EXPERIMENTALRehab at Home Patients
Outpatient PT
ACTIVE COMPARATORIn-person PT patients
Interventions
KinexConnect subjects are asked to Perform CPM therapy for 4 weeks. Perform a KCK home exercise program (HEP) for 6 weeks.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kinex Medical Company, LLClead
- Health Factors Inccollaborator
Study Sites (1)
Des Moines Orthopedic Surgeons
Des Moines, Iowa, 50266, United States
Related Publications (14)
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.
PMID: 28455277BACKGROUNDShukla 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.
PMID: 26843466BACKGROUNDJiang 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.
PMID: 28027679BACKGROUNDKline 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.
PMID: 30329126BACKGROUNDOng 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.
PMID: 25765130BACKGROUNDRondon 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.
PMID: 30992236RESULTBini 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.
PMID: 26940798RESULTMoffet 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.
PMID: 26178888RESULTCorreia 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.
PMID: 30050087RESULTCorreia 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.
PMID: 30816849RESULTFleischman 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.
PMID: 30794229RESULTMoffet 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.
PMID: 27529575RESULTTousignant 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.
PMID: 25840501RESULTBuhagiar 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.
PMID: 28291891RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barron Bremner, DO
Des Moines Orthopedic Suregons
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- All TUG and RoM assessments will be performed by trained physician assistants who will remain blinded to allocation throughout the study
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2019
First Posted
December 10, 2019
Study Start
November 1, 2019
Primary Completion
October 31, 2022
Study Completion
April 30, 2023
Last Updated
June 22, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share