Radial Shock Waves for Functional Disability in Stroke

June 5, 2018 updated by: Marta Imamura

Effect of Radial Shock Waves for the Treatment of Upper Limb Functional Disability in Stroke Sequelae

This is a double blind randomized clinical trial to evaluate the effect of radial shock waves on functional recovery of the upper limb of patients with sequelae of ischemic strokes in the territory of the middle cerebral artery. A total of 20 patients will be enrolled and will undergo motor, functional and cortical excitability evaluations before and after four weekly sessions of radial shockwaves. 5,000 pulses with a frequency of 15 Hz and 3.5 to 4 bar of air pressure will be applied to the active group, resulting in an energy flux density (EFD) of approximately 0.07 mJ/mm2. The sham group will receive identical treatment, except for the fact that no energy flux will be applied.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

22

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

      • Sao Paulo, Brazil, 04116-030
        • Instituto de Medicina Fisica e Reabilitacao HCFMUSP

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical and radiological diagnosis: Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan indicating Stroke in the territory of the middle cerebral artery;
  • 6 to 24 months after stroke date;
  • Stability observed in clinical medical evaluation
  • Granting of written informed consent to participate in the study

Exclusion Criteria:

  • Individuals with a score lower than 24 on the Mini-mental test;
  • Previously documented strokes
  • Pregnancy
  • Patients treated with botulinum toxin, phenol, alcohol or previous surgeries six months before entering the study
  • Bone diseases, pre-existing joint damage, and deformities affecting the patient in a way to interfere with implementation of the proposed therapy
  • Psycho-affective disorder that prevents adherence
  • Joint pain that occurs within the movement range of therapies

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Radial Shockwave
Every patient will receive 5,000 continuous pulses per treatment session, at 3.5 to 4 bar air pressure (resulting in an energy flux density [EFD] of approximately 0.07 mJ/mm2) and at 15Hz frequency. A total of 4 sessions will be performed.
Four weekly sessions of active radial shockwave treatment.
Sham Comparator: Sham Radial Shockwave
Every patient will receive 5,000 continuous pulses per treatment session, without air pressure (resulting in no EFD) and at 15Hz frequency. A total of 4 sessions will be performed.
Four weekly sessions of sham radial shockwave treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment (FMA)
Time Frame: Change from baseline to 8 weeks
Mean change in Fugl Meyer Assessment score after four sessions of Radial Shockwave Therapy (RSWT) as compared to baseline.
Change from baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS)
Time Frame: Baseline, one and two months
Multiple changes in VAS
Baseline, one and two months
Esthesiometry - Von Frey Scale
Time Frame: Baseline, one and two months
Multiple changes in Von Frey Scale
Baseline, one and two months
Upper Limb Modified Ashworth Scale (MAS)
Time Frame: Baseline, one week, two weeks, three weeks, four weeks and two months
Multiple changes in MAS
Baseline, one week, two weeks, three weeks, four weeks and two months
Fugl-Meyer Assessment
Time Frame: Baseline and two months
Changes in Fugl-Meyer Assessment compared to baseline
Baseline and two months
Medical Research Council scale (MRC)
Time Frame: Baseline, one and two months
Multiple changes in MRC scale
Baseline, one and two months
Hand grip
Time Frame: Baseline, one and two months
Multiple changes in Hand grip
Baseline, one and two months
Change in fine motor function measured with Finger Tapping (FT)
Time Frame: Baseline, one and two months
Multiple changes in FT
Baseline, one and two months
Jebsen-Taylor Hand Function Test (JTHFT)
Time Frame: Baseline, one and two months
Multiple changes in JTHFT
Baseline, one and two months
Purdue Pegboard Test (PPBT)
Time Frame: Baseline, one and two months
Multiple changes in PPBT
Baseline, one and two months
Robotic kinematic evaluation (RKE)
Time Frame: Baseline, one and two months
Multiple changes in RKE
Baseline, one and two months
Corticospinal excitability measures with transcranial magnetic stimulation (TMS)
Time Frame: Baseline, one and two months
Multiple changes in Corticospinal excitability
Baseline, one and two months
Pinch strength testing
Time Frame: Baseline, one and two months
Pinch strength testing
Baseline, one and two months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events (AE)
Time Frame: Weekly for two months
Accountability of occurences of Adverse Events
Weekly for two months

Collaborators and Investigators

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

Sponsor

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)

September 1, 2013

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

September 29, 2016

First Submitted That Met QC Criteria

October 3, 2016

First Posted (Estimate)

October 5, 2016

Study Record Updates

Last Update Posted (Actual)

June 7, 2018

Last Update Submitted That Met QC Criteria

June 5, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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