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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A00821-40 | Other Identifier | AFSSAPS (N° ID RCB) |
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Ortheses are commonly used for the repair of damage to the musculoskeletal system. However, immobility, by itself, causes serious side effects that require long and costly rehabilitation. The Sensory Feedback Ortheses allow to artificially maintain the proprioceptive and tactile flow in order to maintain the activity of their host brain areas and thus reduce significantly the usual therapy duration. The clinical study Orthosens will evaluate the efficacy and safety of the Sensory Feedback Ortheses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active vibration | Experimental |
| |
| Placebo Vibration | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORTHOSENS orthosis | Device | with active vibration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Period of time required to recover a normal knee range of motion |
| Measure | Description | Time Frame |
|---|---|---|
| Period of time required to recover a normal knee range of motion with a passive mobilization | The day of inclusion, then 3 times per week during 12 weeks (except at weeks 8 and 12: 4 measurements) | |
| Pain according to Visual Analogic Scale | The day of inclusion, then 3 times per week during 12 weeks (except at weeks 8 and 12: 4 measurements) |
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Inclusion Criteria:
during the inclusion visit.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Axium | Aix-en-Provence | 13090 | France | |||
| Institut de Chirurgie Orthopédique et Sportive |
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| ID | Term |
|---|---|
| D013180 | Sprains and Strains |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ORTHOSENS orthosis |
| Device |
with placebo vibration |
|
| Safety according to adverse event records | At any time during subject participation (12 weeks) |
| Psychological state according to the Incredibly Short Profile of Mood States | 3 times per week from week 1 to week 12 |
| Knee functional state according to IKDC, KOOS and KOOS-PS scores | The Day of inclusion, then 3 times per week during 12 weeks (except at weeks 8 and 12: 4 measurements) |
| Marseille |
| 13008 |
| France |
| Hôpital Sainte-Marguerite | Marseille | 13009 | France |