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COVID-19 pandemic imposed restrictions to normal study conduct
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| Name | Class |
|---|---|
| Hospital da Prelada | OTHER |
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This study was designed to compare the clinical outcomes of a mixed home-based rehabilitation program after arthroscopic rotator cuff repair, incorporating face-to-face sessions as well as sessions performed with a novel digital kinematic biofeedback system against conventional in-person home-based rehabilitation, with the intent of reducing the need for face-to-face sessions.
The investigators hypothesize that the clinical outcomes of such a program will be at least similar to those of conventional rehabilitation.
Patients will be enrolled pre-operatively and then randomized into 2 groups: experimental group and conventional rehabilitation group. Both groups will perform a 12 to 16-week rehabilitation program starting immediately after surgery.
Outcomes will be measured at baseline, 8 and 12 weeks. In patients where a decision is made to extend the program to 16 weeks, another assessment will be made at this point.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Patients in this group will receive a mixed home-based rehabilitation program consisting of face-to-face sessions with a Physical Therapist (with decreasing periodicity depending on program stage) as well as sessions performed with a digital kinematic biofeedback system. |
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| Conventional rehabilitation | Active Comparator | Patients in this group will receive a home-based rehabilitation program consisting of face-to-face sessions with a Physical Therapist 3 times per week, for 1 hour. Patients will also be instructed to perform additional unsupervised sessions in at least two other days of the week. Compliance to these additional sessions is not mandatory, but patients will be asked to fill in a diary regarding these extra-sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital kinematic biofeedback device | Device | The system will be used independently by the patients to perform rehabilitation sessions at home, under remote monitoring from the clinical team. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Constant Score Test | The Constant Score is a functional assessment score specific to the shoulder region. It is the most used instrument to assess the shoulder in Europe and its psychometric properties prove it to be a valid, reliable and responsive measure. | Baseline, 8 weeks after surgery, 12 (and 16) weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in QuickDASH score | The QuickDASH is an 11-item self-administered outcome measure, specific to measure disability and symptoms in individuals with musculoskeletal disorders of the upper limb.It is an instrument widely used for clinical or research purposes and which has proven to be a valid, reliable and responsive measure. | Baseline, 8 weeks after surgery, 12 (and16) weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando D Correia, MD | SWORD Health | Principal Investigator |
| Rosmaninho Seabra, MD | Hospital da Prelada | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital da Prelada | Porto | 4250-449 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33935152 | Derived | Correia FD, Molinos M, Luis S, Carvalho D, Carvalho C, Costa P, Seabra R, Francisco G, Bento V, Lains J. Digitally Assisted Versus Conventional Home-Based Rehabilitation After Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Mar 1;101(3):237-249. doi: 10.1097/PHM.0000000000001780. |
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Study protocol and study aggregate results (including anonymised individual patient data) will be made available
The data will become available upon study publication, for 5 years.
Study protocol will be available through a direct link in this platform. The excel file with the aggregate results will be made available as supplementary information upon study publication.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2018 | Nov 19, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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All patients will be assessed by an independent outcomes assessor
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| Conventional rehabilitation | Other | Patients will receive conventional face-to-face sessions by a Physical Therapist. |
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| Additional face-to-face rehabilitation sessions | Other | Patients will receive face-to-face sessions in addition to sessions performed with the Digital Rehabilitation Device |
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| Change in Shoulder Range of Motion | Shoulder range of motion (in degrees) in the following exercises: sitting external rotation/abduction/flexion; lying internal/external rotation with 90ยบ shoulder abduction | Baseline, 8 weeks after surgery, 12 (and16) weeks. |