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| Name | Class |
|---|---|
| Hospital Clinic of Barcelona | OTHER |
| EASME | UNKNOWN |
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This is a randomized, non-blinded, parallel assignment, clinical trial for the evaluation of safety and efficacy of ReHub, a telerehabilitation system made up of a cloud platform and an exercise kit with smart sensors, for performing rehabilitation exercises after a primary Total Knee Arthroplasty.
Primary TKA patients are allocated randomly to the control arm or the experimental arm with a 1:1 ratio. Both arms follow the usual rapid recovery protocol for TKA surgeries at Hospital Clรญnic de Barcelona, which includes discharge after 2-3 days from the surgery, the prescription of a daily plan of 5 exercises for autonomous rehabilitation and domiciliary visits by a physiotherapist starting approximately 2 weeks after the surgery. The experimental arm participants use ReHub to do their exercises instead of working independently and physiotherapists monitor their performance and adherence remotely.
Outcomes assessment is performed at hospital discharge (baseline), at stitch removal (2 weeks after baseline) and 2 weeks after stitch removal (4 weeks after baseline).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Rehabilitation Group | Active Comparator | Participants follow the usual fast-track protocol used at Hospital Clรญnic de Barcelona for Total Knee Arthroplasty and perform a daily 5-exercise plan autonomously. |
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| ReHub Group | Experimental | Participants follow the usual fast-track protocol used at Hospital Clรญnic de Barcelona for Total Knee Arthroplasty but use the telerehabilitation platform ReHub to do the exercises in their rehabilitation plan at home and to have their progress monitored. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapid Recovery Rehabilitation Programme | Other | Usual intervention at Hospital Clรญnic de Barcelona for post-operative rehabilitation of TKA patients. Participants, already at home after hospital discharge, must perform 5 different exercises 4 times a day (twice in the morning, twice in the afternoon). Participants are also encouraged to walk and stretch their legs. Domiciliary visits by a physiotherapist start at approximately 2 weeks after the surgery to help participants do the exercises. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Active Knee Range of Motion (ยบ) | Range of motion of the replaced knee without the aid of the outcomes assessor will be measured with a conventional goniometer. | Baseline, 2 weeks and 4 weeks after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Timed Up-and-Go test score (s) | The TUG test outcome is the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. | Baseline, 2 weeks and 4 weeks after discharge |
| Change in Self-Reported Pain Level: Visual Analogue Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salvi Prat Fabregat | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic of Barcelona | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37403684 | Derived | Nuevo M, Rodriguez-Rodriguez D, Jauregui R, Fabrellas N, Zabalegui A, Conti M, Prat-Fabregat S. Telerehabilitation following fast-track total knee arthroplasty is effective and safe: a randomized controlled trial with the ReHub(R) platform. Disabil Rehabil. 2024 Jun;46(12):2629-2639. doi: 10.1080/09638288.2023.2228689. Epub 2023 Jul 5. | |
| 34013143 |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ReHub | Device | Participants use a telerehabilitation platform, ReHub, as a guide to perform the TKA rehabilitation exercises of the Rapid Recovery Rehabilitation Programme intervention. The exercise plan in ReHub is carried out by a site physiotherapist on the first day after discharge by using ReHub to acquire the participant's movement pattern with a wearable inertial sensor that transmits data to the platform. The wearable inertial sensor participants must wear tracks movement while they do the TKA rehabilitation exercises. Movement is analysed and feedback is given in real time. At the end of each exercise, participants can select if they have felt pain in a scale from 1 to 10. A physiotherapist monitors the participants' progress remotely. |
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The pain level will be reported by the participant with a Visual Analogue Scale from 0 to 10, with 0 being the absence of pain and 10 being the worst pain imaginable. |
| Baseline, 2 weeks and 4 weeks after discharge |
| Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score | Scores for the WOMAC questionnaire range from 0 to 96, with 0 being the best state and 96 the worst state. | Baseline, 2 weeks and 4 weeks after discharge |
| Change in EuroQol-5D-5L (EQ-5D-5L) score | Scores for the EQ-5D-5L questionnaire are 5-digit numbers, each one representing a different aspect of quality of life. Digits can range from 1 to 5. 11111 is considered the ideal state and 55555 the worst state. 9 is used for absent or non-valid answers. The questionnaire also includes a Visual Analogue Scale for indicating perceived self's health state in a scale from 0 (worst state) to 100 (best state). | Baseline, 2 weeks and 4 weeks after discharge |
| Change in Quadriceps Strength (kg) | Strength of the quadriceps in the intervened leg will be measured with a dynamometer. | Baseline, 2 weeks and 4 weeks after discharge |
| Change in Hamstring Strength (kg) | Strength of the hamstring muscles in the intervened leg will be measured with a dynamometer. | Baseline, 2 weeks and 4 weeks after discharge |
| Satisfaction with ReHub: System Usability Scale | Measured with the score from the System Usability Scale questionnaire, which can range from 0 (worst result) to 100 (best result). Only for participants in the experimental arm. | 4 weeks after discharge |
| Change in Passive Knee Range of Motion (ยบ) | Range of motion of the replaced knee with the aid of the outcomes assessor will be measured with a conventional goniometer. | Baseline, 2 weeks and 4 weeks after discharge |
| Nuevo M, Mahdavi H, Rodriguez D, Faura T, Fabrellas N, Balocco S, Conti M, Castagna A, Prat S. Evaluation of Safety and Efficacy of ReHub in Patients Who Underwent Primary Total Knee Arthroplasty: Study Protocol for a Randomized Controlled Trial. Int J Surg Protoc. 2021 Apr 19;25(1):34-41. doi: 10.29337/ijsp.138. |
| D012216 |
| Rheumatic Diseases |