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

NCT05255549 | Completed DMC

• 1 other identifier: 31032021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Stroke; Triceps Sural Spasticity; Extracorporeal Shockwave Therapy

Outcome Measures

Primary Outcomes (1)

• Feasibility of two kind treatments proposed

  The intervention is feasible if at least 80% of the enrolled patients complete the entire treatment foreseen in the allocation group

  T1 after 4 weeks from T0 (Enrollment)

Secondary Outcomes (7)

• Change in Walking Resistance

  T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0

• Change in Level of mobility and balance

  T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0

• Change in spasticity

  T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0

• Change in Passive ROM of the ankle in dorsiflexion

  T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0

• Change in Leg Pain

  T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0

Study Arms (2)

Group I

EXPERIMENTAL

Procedure: ESWT + Stretching

Group II

SHAM COMPARATOR

Procedure: ESWT and SHAM + Stretching

Interventions

ESWT + Stretching PROCEDURE

3 weeks intervention: * 3 sessions of ESWT, once a week * 6 sessions of passive stretching, twice a week

Group I

ESWT and SHAM + Stretching PROCEDURE

3 weeks intervention: * 1 sessions of ESWT + 2 sessions of Sham, once a week * 6 sessions of passive stretching, twice a week

Group II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

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

Reggio Emilia, Emilia-Romagna, 42123, Italy

Location

MeSH Terms

Conditions

Stroke

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Stefania Testoni, Dr

  Azienda AUSLRE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: February 24, 2022
• Study Start: July 22, 2021
• Primary Completion: July 22, 2022
• Study Completion: July 22, 2022
• Last Updated: June 24, 2025

Record last verified: 2021-11

Locations

IT (1)