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| Name | Class |
|---|---|
| University of Turin, Italy | OTHER |
| Presidio Sanitario San Camillo, Turin | UNKNOWN |
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This is a randomized, non-blinded, parallel assignment, clinical trial for the evaluation of usability and effectiveness 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 Hip Arthroplasty (THA).
Patients admitted to Presidio San Camillo after a THA surgery are randomly allocated to the control arm or the experimental arm with a 1:1 ratio. Participants in both arms receive inpatient care and rehabilitation for 2 weeks at San Camillo. At discharge, they are prescribed with the same daily plan of 5 exercises for autonomous home-based rehabilitation. 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 San Camillo admission (baseline), at San Camillo discharge (2 weeks from baseline) and 3 weeks after San Camillo discharge (5 weeks from baseline).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Rehabilitation Group | Active Comparator | Participants follow the usual exercise plan designed at Presidio San Camillo for Total Hip Arthroplasty autonomously |
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| ReHub Group | Experimental | Participants follow the usual exercise plan designed at Presidio San Camillo for Total Hip Arthroplasty but use the telerehabilitation platform ReHub to do the exercises at home and to have their progress monitored. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Home-based Rehabilitation Plan | Other | Usual intervention at Presidio Sanitario San Camillo for post-operative rehabilitation of THA patients. Participants receive inpatient care and rehabilitation for 2 weeks. At discharge, they receive a 5-exercise home-based rehabilitation plan. For the sake of homogeneity of all participants, they receive from 2 to 4 of training prior to discharge. At home, participants shall perform the exercises in the rehabilitation plan daily. |
| 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 as the score. | Baseline, 2 weeks and 5 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hip Flexion Range of Motion (ยบ) | Range of motion of the replaced hip for flexion, without the aid of the outcomes assessor, is measured with a conventional goniometer. | Baseline, 2 weeks and 5 weeks from baseline |
| Change in Hip Extension Range of Motion (ยบ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Alessandro Minetto | University of Turin, Department of Surgical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Presidio Sanitario San Camillo | Turin | Piedmont | 10131 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33054811 | Derived | Busso C, Castorina G, Di Monaco M, Rodriguez D, Mahdavi H, Balocco S, Trucco M, Conti M, Castagna A, Minetto MA. Effectiveness of a home-based telerehabilitation system in patients after total hip arthroplasty: study protocol of a randomized controlled trial. Trials. 2020 Oct 14;21(1):852. doi: 10.1186/s13063-020-04791-4. |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ReHub Home-based Rehabilitation Plan | Device | Combination of the usual intervention at Presidio Sanitario San Camillo for post-operative rehabilitation of THA patients with ReHub, a telerehabilitation platform that serves as a guide to perform the TKA rehabilitation exercises. Participants receive inpatient care and rehabilitation at San Camillo for 2 weeks. At discharge, a 5-exercise home-based rehabilitation plan is carried out by a site physiotherapist by using ReHub to acquire the participant's movement pattern with a wearable inertial sensor. Participants receive from 2 to 4 sessions of ReHub prior to discharge. At home, participants shall perform the exercises in the rehabilitation plan with ReHub daily. 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. 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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Range of motion of the replaced hip for extension, without the aid of the outcomes assessor, is measured with a conventional goniometer. |
| Baseline, 2 weeks and 5 weeks from baseline |
| Change in Hip Abduction Range of Motion (ยบ) | Range of motion of the replaced hip for abduction, without the aid of the outcomes assessor, is measured with a conventional goniometer. | Baseline, 2 weeks and 5 weeks from baseline |
| Change in Quadriceps Strength (kg) | Strength of the quadriceps in the intervened leg is measured with a dynamometer. | Baseline, 2 weeks and 5 weeks from baseline |
| Change in Extension Strength (kg) | Strength of the intervened leg while performing an extension movement is measured with a dynamometer. | Baseline, 2 weeks and 5 weeks from baseline |
| Change in Abduction Strength (kg) | Strength of the intervened leg while performing an abduction movement is measured with a dynamometer. | Baseline, 2 weeks and 5 weeks from baseline |
| Change in Self-Reported Pain Level at Rest: Numerical Rating Scale | The pain level of the intervened hip at rest is reported by the participant with a Numerical Rating Scale from 0 to 10, with 0 being the absence of pain and 100 being the worst possible pain. | Baseline, 2 weeks and 5 weeks from baseline |
| Change in Self-Reported Pain Level in Movement: Numerical Rating Scale | The pain level of the intervened hip in movement is reported by the participant with a Numerical Rating Scale from 0 to 10, with 0 being the absence of pain and 100 being the worst possible pain. | Baseline, 2 weeks and 5 weeks from baseline |
| Change in Hip disability and Osteoarthritis Outcome Score (HOOS) | Scores for the HOOS questionnaire range from 0% to 100%, with 0 being the worst possible score and 100 the best possible score. | Baseline, 2 weeks and 5 weeks from baseline |
| Change in Functional Independence Measure (FIM) score | Scores for the FIM questionnaire range from 18 to 126, with 13 being the worst possible score and 100 the best possible score. Individual items (18) are scored from 1 (worst) to 7 (best). | Baseline, 2 weeks and 5 weeks from baseline |
| Global Rating Of Change | The participant will report their perception of change from the start to the end of the study with a number from 1 (substantial worsening) to 6 (total recovery). | 5 weeks from baseline |
| 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. | 5 weeks from baseline |
| D012216 |
| Rheumatic Diseases |