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Feasibility of ESWT Treatment in Post-stroke Patients With Triceps Sural Spasticity (Waves2021)

Primary Purpose

Stroke

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

ESWT + Stretching

ESWT and SHAM + Stretching

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Triceps Sural Spasticity, Extracorporeal Shockwave Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Group I

Group II

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Walking Resistance

6 minute walking test

Change in Level of mobility and balance

Timed Up & Go Test

Change in spasticity

Modified Ashworth Scale (MAS). Score from 0 to 4, higher scores mean a worse outcome

Change in Passive ROM of the ankle in dorsiflexion

Passive ankle Range of Motion (p-ROM)

Change in Leg Pain

Numeric Pain Rating Scale (NPRS) Score from 0 to 10, higher scores mean a worse outcome

Change in Ability to carry out activities of daily living

Lower Extremity Functional Scale (LEFS). Score from 0 to 80, higher scores mean a better outcome.

Change in triceps clones

Presence of ankle clonus

Full Information

NCT ID

NCT05255549

First Posted

February 5, 2022

Last Updated

February 15, 2022

Sponsor

Azienda Unità Sanitaria Locale Reggio Emilia

1. Study Identification

Unique Protocol Identification Number

NCT05255549

Brief Title

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

Acronym

Waves2021

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

July 22, 2021 (Actual)

Primary Completion Date

July 22, 2022 (Anticipated)

Study Completion Date

July 22, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Azienda Unità Sanitaria Locale Reggio Emilia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Stroke, Triceps Sural Spasticity, Extracorporeal Shockwave Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group I

Arm Type

Experimental

Arm Title

Group II

Arm Type

Sham Comparator

Intervention Type

Procedure

Intervention Name(s)

ESWT + Stretching

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

ESWT and SHAM + Stretching

Intervention Description

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

Primary Outcome Measure Information:

Title

Feasibility of two kind treatments proposed

Description

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

Time Frame

T1 after 4 weeks from T0 (Enrollment)

Secondary Outcome Measure Information:

Title

Change in Walking Resistance

Description

6 minute walking test

Time Frame