Feasibility of ESWT Treatment in Post-stroke Patients With Triceps Sural Spasticity
- Conditions
- Stroke
- Interventions
- Procedure: ESWT + StretchingProcedure: ESWT and SHAM + Stretching
- Registration Number
- NCT05255549
- Lead Sponsor
- Azienda Unità Sanitaria Locale Reggio Emilia
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group I ESWT + Stretching - Group II ESWT and SHAM + Stretching -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change in Walking Resistance T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0 6 minute walking test
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 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
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
Trial Locations
- Locations (1)
Operational Unit of Physical Medicine and Rehabilitation AUSL - IRCCS Reggio Emilia
🇮🇹Reggio Emilia, Emilia Romagna, Italy