Feasibility of ESWT Treatment in Post-stroke Patients With Triceps Sural Spasticity

Study Overview
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Brief Summary
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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).

Official Title
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ESWT Treatment in Post-stroke Patients With Triceps Sural: a Feasibility RCT

Conditions
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Stroke

Intervention / Treatment
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* Procedure: ESWT + Stretching
* Procedure: ESWT and SHAM + Stretching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients of legal age Time elapsed since the stroke between 6 and 60 months Autonomous or supervised walking with or without aids Spasticity of the sural triceps> 1 on the MAS scale Exclusion Criteria: Joint stiffness of the lower limbs due to other pathologies (ex orthopedic or rheumatological); Conditions that interfere with evaluation or collaboration in rehabilitation treatment (major psychiatric illnesses, clearly detectable cognitive deficits, severe pre-existing disabilities, sensory disturbances, etc.) Focal antispasmodic toxin treatments in the previous 3 months or phenolic blocks in the previous 9 months in the treatment region Treatments with central antispasmodic drugs with dosage modifications in the last week of starting treatment Individual neurorehabilitation treatments in progress

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br> | Procedure: ESWT + Stretching<br>* 3 weeks intervention: 3 sessions of ESWT, once a week 6 sessions of passive stretching, twice a week<br>|
| Sham Comparator: Group II<br> | Procedure: ESWT and SHAM + Stretching<br>* 3 weeks intervention: 1 sessions of ESWT + 2 sessions of Sham, once a week 6 sessions of passive stretching, twice a week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Triceps Sural Spasticity, Extracorporeal Shockwave Therapy