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The main objective is to evaluate the feasibility of two different rehabilitation protocols that differed from the number of treatment sessions (1 session of ESWT versus 3 weekly sessions of ESWT), in patients with triceps surae spasticity after stroke. In both arms the other ESWT parameters (types of ESWT, intensity, frequency, location) and stretching sessions are the same.
Secondary objectives: to compare functional performances in these two groups of patients receiving the different rehabilitation protocol with ESWT, using the following parameters:
- Six Minutes walking test (6MWT) ; - Time Up & Go (TUG); - Modified Ashworth scale (MAS); - Lower Extremity Functional Scale (LEFS); - passive ankle range of motion (p-ROM), pain (NRS); and presence of ankle clonus. These parameters are assessed during baseline (T0), after 4 weeks (T1) and after 12 weeks (T2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental |
| |
| Group II | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESWT + Stretching | Procedure | 3 weeks intervention:
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of two kind treatments proposed | The intervention is feasible if at least 80% of the enrolled patients complete the entire treatment foreseen in the allocation group | T1 after 4 weeks from T0 (Enrollment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Walking Resistance | 6 minute walking test | T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0 |
| Change in Level of mobility and balance | Timed Up & Go Test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefania Testoni, Dr | Azienda AUSLRE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Operational Unit of Physical Medicine and Rehabilitation AUSL - IRCCS Reggio Emilia | Reggio Emilia | Emilia-Romagna | 42123 | Italy |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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| ESWT and SHAM + Stretching | Procedure | 3 weeks intervention:
|
|
| T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0 |
| Change in spasticity | Modified Ashworth Scale (MAS). Score from 0 to 4, higher scores mean a worse outcome | T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0 |
| Change in Passive ROM of the ankle in dorsiflexion | Passive ankle Range of Motion (p-ROM) | T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0 |
| Change in Leg Pain | Numeric Pain Rating Scale (NPRS) Score from 0 to 10, higher scores mean a worse outcome | T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0 |
| Change in Ability to carry out activities of daily living | Lower Extremity Functional Scale (LEFS). Score from 0 to 80, higher scores mean a better outcome. | T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0 |
| Change in triceps clones | Presence of ankle clonus | T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |