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This is a randomized, evaluator-blinded, non-profit, single-center, exploratory, medical device clinical trial aimed at evaluating the efficacy in terms of reduction of functional limitation of the combination of occupational therapy, paraffin therapy, and robotic arm mobilization compared to the center's SoC, i.e. paraffin therapy and occupational therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMADEO | Experimental | Rehabilitation treatment with occupational therapy, paraffin therapy and mobilization with robotic arm (AMADEO) of the fingers. |
|
| Standard care | Other | Rehabilitation treatment with occupational therapy and paraffin therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMADEO | Device | 304 / 5.000 The rehabilitation treatment includes 10 sessions of combined treatment of paraffin therapy, functional occupational therapy and polyarticular mobilization of the fingers with a robotic arm (Amadeo). The sessions will be scheduled 2 times a week for 5 consecutive weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| VAS functionality | VAS scale | Baseline, 1, 3 and 6 months after treatment |
| Dreiser index | Dreiser index | Baseline, 1, 3 and 6 months after treatment |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Sacro Cuore Don Calabria di Negrar | Negrar | Verona | Italy |
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| Standard of care | Procedure | The rehabilitation treatment includes 10 sessions of combined treatment of paraffin therapy and occupational therapy for functional purposes. The sessions will be scheduled 2 times a week for 5 consecutive weeks. |
|
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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