Stroke
Conditions
Keywords
Stroke, Triceps Sural Spasticity, Extracorporeal Shockwave Therapy
Brief summary
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).
Interventions
PROCEDUREESWT + Stretching
3 weeks intervention: * 3 sessions of ESWT, once a week * 6 sessions of passive stretching, twice a week
PROCEDUREESWT and SHAM + Stretching
3 weeks intervention: * 1 sessions of ESWT + 2 sessions of Sham, once a week * 6 sessions of passive stretching, twice a week
Sponsors
Azienda USL Reggio Emilia - IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of two kind treatments proposed | T1 after 4 weeks from T0 (Enrollment) | The intervention is feasible if at least 80% of the enrolled patients complete the entire treatment foreseen in the allocation group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Level of mobility and balance | T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0 | Timed Up & Go Test |
| Change in spasticity | T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0 | Modified Ashworth Scale (MAS). Score from 0 to 4, higher scores mean a worse outcome |
| Change in Passive ROM of the ankle in dorsiflexion | T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0 | Passive ankle Range of Motion (p-ROM) |
| Change in Walking Resistance | T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0 | 6 minute walking test |
| Change in Ability to carry out activities of daily living | T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0 | Lower Extremity Functional Scale (LEFS). Score from 0 to 80, higher scores mean a better outcome. |
| Change in triceps clones | T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0 | Presence of ankle clonus |
| Change in Leg Pain | T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0 | Numeric Pain Rating Scale (NPRS) Score from 0 to 10, higher scores mean a worse outcome |
Countries
Italy
Outcome results
None listed