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

NCT ID: NCT05255549

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-22
• Study Completion Date: 2022-07-22

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).

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group I

Group Type: EXPERIMENTAL

ESWT + Stretching

Intervention Type: PROCEDURE

3 weeks intervention:

• 3 sessions of ESWT, once a week
• 6 sessions of passive stretching, twice a week

Group II

Group Type: SHAM_COMPARATOR

ESWT and SHAM + Stretching

Intervention Type: PROCEDURE

3 weeks intervention:

• 1 sessions of ESWT + 2 sessions of Sham, once a week
• 6 sessions of passive stretching, twice a week

Interventions

ESWT + Stretching

3 weeks intervention:

• 3 sessions of ESWT, once a week
• 6 sessions of passive stretching, twice a week

Intervention Type: 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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefania Testoni, Dr

Role: PRINCIPAL_INVESTIGATOR

Azienda AUSLRE

Locations

Operational Unit of Physical Medicine and Rehabilitation AUSL - IRCCS Reggio Emilia

Reggio Emilia, Emilia-Romagna, Italy

Countries

Italy

Other Identifiers

31032021

Identifier Type: -

Identifier Source: org_study_id