Radial Shock Waves for Functional Disability in Stroke
- Conditions
- Ischemic Stroke
- Interventions
- Device: Active Radial ShockwaveDevice: Sham Radial Shockwave
- Registration Number
- NCT02924168
- Lead Sponsor
- Marta Imamura
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Radial Shockwave 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. Sham Radial Shockwave 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.
- Primary Outcome Measures
Name Time Method Fugl-Meyer Assessment (FMA) 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.
- Secondary Outcome Measures
Name Time Method Corticospinal excitability measures with transcranial magnetic stimulation (TMS) Baseline, one and two months Multiple changes in Corticospinal excitability
Jebsen-Taylor Hand Function Test (JTHFT) Baseline, one and two months Multiple changes in JTHFT
Change in fine motor function measured with Finger Tapping (FT) Baseline, one and two months Multiple changes in FT
Purdue Pegboard Test (PPBT) Baseline, one and two months Multiple changes in PPBT
Medical Research Council scale (MRC) Baseline, one and two months Multiple changes in MRC scale
Robotic kinematic evaluation (RKE) Baseline, one and two months Multiple changes in RKE
Pinch strength testing Baseline, one and two months Pinch strength testing
Visual Analogue Scale (VAS) Baseline, one and two months Multiple changes in VAS
Esthesiometry - Von Frey Scale Baseline, one and two months Multiple changes in Von Frey Scale
Fugl-Meyer Assessment Baseline and two months Changes in Fugl-Meyer Assessment compared to baseline
Hand grip Baseline, one and two months Multiple changes in Hand grip
Upper Limb Modified Ashworth Scale (MAS) Baseline, one week, two weeks, three weeks, four weeks and two months Multiple changes in MAS
Trial Locations
- Locations (1)
Instituto de Medicina Fisica e Reabilitacao HCFMUSP
🇧🇷Sao Paulo, Brazil