Ischemic StrokeNCT02924168
Radial Shock Waves for Functional Disability in Stroke
A study testing Active Radial Shockwave in people with Ischemic Stroke, run by Marta Imamura at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Active Radial Shockwave
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2013to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Medicina Fisica e Reabilitacao HCFMUSP
São Paulo, 04116-030
About this study
Official title: 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.
- Conditions
- Ischemic Stroke
- Being tested
- Active Radial Shockwave, Sham Radial Shockwave
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Radial ShockwaveDevice
Four weekly sessions of active radial shockwave treatment.
Sham Radial ShockwaveDevice
Four weekly sessions of sham radial shockwave treatment.
| Study group | Role | What they receive |
|---|---|---|
| Active Radial Shockwave | Experimental | 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. Receives: Device: Active Radial Shockwave |
| Sham Radial Shockwave | Sham comparator | 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. Receives: Device: Sham Radial Shockwave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment (FMA)
Mean change in Fugl Meyer Assessment score after four sessions of Radial Shockwave Therapy (RSWT) as compared to baseline.
Measured: Change from baseline to 8 weeks
Secondary outcomes (12)
Visual Analogue Scale (VAS)
Multiple changes in VAS
Measured: Baseline, one and two months
Esthesiometry - Von Frey Scale
Multiple changes in Von Frey Scale
Measured: Baseline, one and two months
Upper Limb Modified Ashworth Scale (MAS)
Multiple changes in MAS
Measured: Baseline, one week, two weeks, three weeks, four weeks and two months
Fugl-Meyer Assessment
Changes in Fugl-Meyer Assessment compared to baseline
Measured: Baseline and two months
Medical Research Council scale (MRC)
Multiple changes in MRC scale
Measured: Baseline, one and two months
Hand grip
Multiple changes in Hand grip
Measured: Baseline, one and two months
Change in fine motor function measured with Finger Tapping (FT)
Multiple changes in FT
Measured: Baseline, one and two months
Jebsen-Taylor Hand Function Test (JTHFT)
Multiple changes in JTHFT
Measured: Baseline, one and two months
Purdue Pegboard Test (PPBT)
Multiple changes in PPBT
Measured: Baseline, one and two months
Robotic kinematic evaluation (RKE)
Multiple changes in RKE
Measured: Baseline, one and two months
Corticospinal excitability measures with transcranial magnetic stimulation (TMS)
Multiple changes in Corticospinal excitability
Measured: Baseline, one and two months
Pinch strength testing
Pinch strength testing
Measured: Baseline, one and two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startSep 2013
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marta Imamura
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marta Imamura, University of Sao Paulo
- Investigators
- Marta Imamura, MD, Principal investigator, Instituto de Medicina Física e Reabilitação HCFMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924168
- Sponsor's protocol ID
- 19109813.1.0000.0068
- Status last verified
- Jun 2018
- First submitted
- 29 Sep 2016
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Radial Shock Waves for the Treatment of Upper Limb Functional Disability in Stroke Sequelae
- ClinicalTrials.gov ID
- NCT02924168
- Acronym / sponsor ID
- 19109813.1.0000.0068
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Marta ImamuraUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Radial Shockwave | Experimental | Device: Active Radial ShockwaveEvery 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. |
| Sham Radial Shockwave | Sham comparator | Device: Sham Radial ShockwaveEvery 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Radial ShockwaveFour weekly sessions of active radial shockwave treatment. | Device | Active Radial Shockwave |
| Sham Radial ShockwaveFour weekly sessions of sham radial shockwave treatment. | Device | Sham Radial Shockwave |
Primary outcome
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.
12 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: Baseline, one and two months
Esthesiometry - Von Frey Scale
Time frame: 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
Fugl-Meyer Assessment
Time frame: Baseline and two months
Medical Research Council scale (MRC)
Time frame: Baseline, one and two months
Hand grip
Time frame: Baseline, one and two months
Change in fine motor function measured with Finger Tapping (FT)
Time frame: Baseline, one and two months
Jebsen-Taylor Hand Function Test (JTHFT)
Time frame: Baseline, one and two months
Purdue Pegboard Test (PPBT)
Time frame: Baseline, one and two months
Robotic kinematic evaluation (RKE)
Time frame: Baseline, one and two months
Corticospinal excitability measures with transcranial magnetic stimulation (TMS)
Time frame: Baseline, one and two months
Pinch strength testing
Time frame: Baseline, one and two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
- Individual participant dataSharing planned: No
Related trials for Ischemic Stroke
Not yet recruiting
Cardiac CT Angiography in Acute Stroke Imaging (SCOPE-CT)
Acute Ischemic Stroke and Transient Ischemic Attacks
Not yet recruitingPhase 3
Metformin in Acute Ischemic Stroke
Acute Ischemic Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingPhase 3
A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Person Was Last Seen Well
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Imamura, MD principal investigator
Instituto de Medicina Física e Reabilitação HCFMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Radial Shockwave in people with Ischemic Stroke, run by Marta Imamura at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (FMA) (time frame: Change from baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2018.