Early Radial Shock Waves Treatment on Spasticity in Patients With Stroke in Sub-acute Phase

March 19, 2022 updated by: Stefano Brunelli

Effects of an Early Radial Shock Waves Therapy on Spasticity of the Upper Limb and on Functional Outcome in Patients With Stroke in Subacute Phase

Hands and wrist spasticity are a common post stroke complication and often lead to restrictions in daily living activities. Spasticity causes changes in muscle composition such as accumulation of collagenous connective tissue and progressive loss of skeletal muscle fibres and these changes start almost immediately after a vascular event. Radial Shock Wave Therapy (rSWT) is a valid alternative rehabilitating tool in managing chronic spasticity but no study has so far investigated the effect in a recently onset hemiparesis. The aim of this study is to evaluate the efficacy of an early radial shock wave therapy in improving spasticity of the upper limb in patients with a recent onset stroke. The secondary outcome is to investigate the improvement of upper limb motor functionality, passive range of motion and joint pain and to determine if it can lead to a better performance in daily living activities. This study is a randomized controlled trial double arm single blind. The investigators plan to enrol 40 hemiplegic patients with sub-acute stroke and randomly assign them to an experimental or control group. The experimental group (EG) will perform one radial shock wave therapy session a week for 8 weeks administered during the daily morning 40 minutes of conventional rehabilitation treatment. The control group (CG) 40-minutes of conventional rehabilitation treatment for 5 days per week in the morning for 8 weeks. All patients performed in the afternoon a second daily session of 40 minutes of conventional rehabilitation therapy 5 days per week. The Modified Ashworth Scale (MAS), Fugl-Meyer Assessment Upper Extremity (FMA-UE) (with motricity, Passive Range of Motion (PROM) and pain sub-scores of upper extremity part of the scale), Modified Barthel Index and Visual Analogue Scale (VAS) for patient's benefit perceived, will be evaluated before and a week after the last intervention. MAS will be administered once a week, before rSWT treatment. The investigators plan to have a 1 month follow up during which every outcome measure will be administered. The investigators hypothesize that radial shock waves therapy, started early and associated with traditional physiotherapy, may be more effective in promoting the reduction of spasticity and pain of the upper limb, improve its functionality and therefore a reduction in disability, compared to conventional rehabilitation treatment. A reduction in the use of analgesic and muscle relaxants drugs is also conceivable

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00179
        • Stefano Brunelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of hemiparesis after an ischemic or hemorrhagic stroke
  • Onset of spasticity within 3 months from acute stroke
  • First-stroke survivors with confirmed brain lesions by tomography or magnetic resonance imaging
  • Adults (age between 18 and 80 years)
  • Post-stroke upper limb spasticity ranging 1-4 according to the Modified Ashworth Scale

Exclusion Criteria:

  • No treatment of the limb spasticity with botulinum toxin, phenol, alcohol, or surgery in the last 6 months
  • Presence of an unstable medical condition
  • Contraindications to shock waves treatment (pregnancy, cancer, coagulopathies, pacemakers, skin pathologies)
  • Global aphasia
  • All subjects who scored above 25 on the Mini-Mental State Examination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rSWT group
Radial Extracorporeal Shock Wave Therapy on spastic muscles of upper limb
Procedure: Radial Extracorporeal Shock Wave Therapy
rSWT group: One radial shock wave therapy session a week for 8 weeks (parameters: 1.5 bar, 10 Hz, 2000 shots for each muscle group treated) administered daily during the morning for 40 minutes of conventional rehabilitation treatment.
Active Comparator: Control group
conventional physiotherapy
Procedure: Conventional physiotherapy
Control group: 40-minutes of conventional rehabilitation treatment 5 days per week in the morning (strength exercise, trunk control exercise, stretching exercise, occupational therapy, and neurodevelopmental facilitation techniques) for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Modified Ashworth Scale at 9 weeks and at 13 weeks
Time Frame: baseline the first rSWT treatment, at 9 weeks (1 week after the last treatment) and at 13 weeks (follow up at 4 weeks after the last treatment)
A 6-point scale grading the resistance of a relaxed limb to rapid passive stretch
baseline the first rSWT treatment, at 9 weeks (1 week after the last treatment) and at 13 weeks (follow up at 4 weeks after the last treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline FUGL-MEYER ASSESSMENT UPPER EXTREMITY (FMA-UE) at 9 weeks and at 13 weeks
Time Frame: baseline the first rSWT treatment, at 9 weeks (1 week after the last treatment) and at 13 weeks (follow up at 4 weeks after the last treatment)
It is designed to assess motor functioning, sensation, pain and joint functioning in patients with post-stroke hemiplegia.
baseline the first rSWT treatment, at 9 weeks (1 week after the last treatment) and at 13 weeks (follow up at 4 weeks after the last treatment)
Change from baseline Barthel Index at 9 weeks and at 13 weeks
Time Frame: baseline the first rSWT treatment, at 9 weeks (1 week after the last treatment) and at 13 weeks (follow up at 4 weeks after the last treatment)
it is a 10-item ordinal scale that cover mobility and self-care domains; scores range from 0 (total dependence in ADL) to 100 (complete independence)
baseline the first rSWT treatment, at 9 weeks (1 week after the last treatment) and at 13 weeks (follow up at 4 weeks after the last treatment)
visual analogue scale (VAS)
Time Frame: at 9 weeks (at the end of the last rESWT treatment)
to rate their degree of perceived benefit from treatment
at 9 weeks (at the end of the last rESWT treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stefano Brunelli

Investigators

  • Principal Investigator: Noemi Gentileschi, MD, Fondazione Santa Lucia Roma Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2020

Primary Completion (Actual)

September 20, 2021

Study Completion (Actual)

September 27, 2021

Study Registration Dates

First Submitted

April 20, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

April 1, 2022

Last Update Submitted That Met QC Criteria

March 19, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prot. CE/PROG.768 FSL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following article publication.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose; For individual participant data meta-analysis.Proposals should be directed to the personal author's mail address

IPD Sharing Supporting Information Type

  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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