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

NCT05255549 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-06-24

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Azienda USL Reggio Emilia - IRCCS

    lead OTHER_GOV

Principal Investigators

  • Stefania Testoni, Dr · Azienda AUSLRE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-22
Primary Completion
2022-07-22
Completion
2022-07-22

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05255549 on ClinicalTrials.gov