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

Azienda USL Reggio Emilia - IRCCS1 site in 1 country30 target enrollmentJuly 22, 2021

ConditionsStroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke
Sponsor: Azienda USL Reggio Emilia - IRCCS
Enrollment: 30
Locations: 1
Primary Endpoint: Feasibility of two kind treatments proposed
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

July 22, 2021

End Date

July 22, 2022

Last Updated

10 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Azienda USL Reggio Emilia - IRCCS

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Feasibility of two kind treatments proposed

Time Frame: T1 after 4 weeks from T0 (Enrollment)

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

Secondary Outcomes

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)
Change in Ability to carry out activities of daily living(T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0)
Change in triceps clones(T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0)