NCT05255549

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Azienda USL Reggio Emilia - IRCCS · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Stroke

Interventions

Type	Name	Description
PROCEDURE	ESWT + Stretching	3 weeks intervention: * 3 sessions of ESWT, once a week * 6 sessions of passive stretching, twice a week
PROCEDURE	ESWT 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

Timeline

• Start date: 2021-07-22
• Primary completion: 2022-07-22
• Completion: 2022-07-22
• First posted: 2022-02-24
• Last updated: 2025-06-24

Locations

1 site across 1 country: Italy