Clinical trial NCT05255549: Feasibility of ESWT Treatment in Post-stroke Patients With Triceps Sural Spasticity
Official title: ESWT Treatment in Post-stroke Patients With Triceps Sural: a Feasibility RCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Stroke
Triceps Sural Spasticity
Extracorporeal Shockwave Therapy
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2022-02-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of two kind treatments proposed
timeFrame: T1 after 4 weeks from T0 (Enrollment)
Secondary outcomes:
measure: Change in Walking Resistance
timeFrame: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
measure: Change in Level of mobility and balance
timeFrame: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
measure: Change in spasticity
timeFrame: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
measure: Change in Passive ROM of the ankle in dorsiflexion
timeFrame: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
measure: Change in Leg Pain
timeFrame: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
measure: Change in Ability to carry out activities of daily living
timeFrame: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
measure: Change in triceps clones
timeFrame: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Operational Unit of Physical Medicine and Rehabilitation AUSL - IRCCS Reggio Emilia
state: Emilia Romagna
Study officials:
affiliation: Azienda AUSLRE
name: Stefania Testoni, Dr
role: PRINCIPAL_INVESTIGATOR
References: