- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02924168
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
Intervention / Treatment
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
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Sao Paulo, Brazil, 04116-030
- Instituto de Medicina Fisica e Reabilitacao HCFMUSP
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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.
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Four weekly sessions of active radial shockwave treatment.
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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.
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Four weekly sessions of sham radial shockwave treatment.
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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
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Mean change in Fugl Meyer Assessment score after four sessions of Radial Shockwave Therapy (RSWT) as compared to baseline.
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Change from baseline to 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale (VAS)
Time Frame: Baseline, one and two months
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Multiple changes in VAS
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Baseline, one and two months
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Esthesiometry - Von Frey Scale
Time Frame: Baseline, one and two months
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Multiple changes in Von Frey Scale
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Baseline, one and two months
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Upper Limb Modified Ashworth Scale (MAS)
Time Frame: Baseline, one week, two weeks, three weeks, four weeks and two months
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Multiple changes in MAS
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Baseline, one week, two weeks, three weeks, four weeks and two months
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Fugl-Meyer Assessment
Time Frame: Baseline and two months
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Changes in Fugl-Meyer Assessment compared to baseline
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Baseline and two months
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Medical Research Council scale (MRC)
Time Frame: Baseline, one and two months
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Multiple changes in MRC scale
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Baseline, one and two months
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Hand grip
Time Frame: Baseline, one and two months
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Multiple changes in Hand grip
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Baseline, one and two months
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Change in fine motor function measured with Finger Tapping (FT)
Time Frame: Baseline, one and two months
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Multiple changes in FT
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Baseline, one and two months
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Jebsen-Taylor Hand Function Test (JTHFT)
Time Frame: Baseline, one and two months
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Multiple changes in JTHFT
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Baseline, one and two months
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Purdue Pegboard Test (PPBT)
Time Frame: Baseline, one and two months
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Multiple changes in PPBT
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Baseline, one and two months
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Robotic kinematic evaluation (RKE)
Time Frame: Baseline, one and two months
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Multiple changes in RKE
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Baseline, one and two months
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Corticospinal excitability measures with transcranial magnetic stimulation (TMS)
Time Frame: Baseline, one and two months
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Multiple changes in Corticospinal excitability
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Baseline, one and two months
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Pinch strength testing
Time Frame: Baseline, one and two months
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Pinch strength testing
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Baseline, one and two months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events (AE)
Time Frame: Weekly for two months
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Accountability of occurences of Adverse Events
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Weekly for two months
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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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19109813.1.0000.0068
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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