Clinical trial NCT02924168: Radial Shock Waves for Functional Disability in Stroke
Official title: Effect of Radial Shock Waves for the Treatment of Upper Limb Functional Disability in Stroke Sequelae
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA)
timeFrame: Change from baseline to 8 weeks
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: Baseline, one and two months
measure: Esthesiometry - Von Frey Scale
timeFrame: Baseline, one and two months
measure: Upper Limb Modified Ashworth Scale (MAS)
timeFrame: Baseline, one week, two weeks, three weeks, four weeks and two months
measure: Fugl-Meyer Assessment
timeFrame: Baseline and two months
measure: Medical Research Council scale (MRC)
timeFrame: Baseline, one and two months
measure: Hand grip
timeFrame: Baseline, one and two months
measure: Change in fine motor function measured with Finger Tapping (FT)
timeFrame: Baseline, one and two months
measure: Jebsen-Taylor Hand Function Test (JTHFT)
timeFrame: Baseline, one and two months
measure: Purdue Pegboard Test (PPBT)
timeFrame: Baseline, one and two months
measure: Robotic kinematic evaluation (RKE)
timeFrame: Baseline, one and two months
measure: Corticospinal excitability measures with transcranial magnetic stimulation (TMS)
timeFrame: Baseline, one and two months
measure: Pinch strength testing
timeFrame: Baseline, one and two months
Other outcomes:
measure: Adverse Events (AE)
timeFrame: Weekly for two months
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto de Medicina Fisica e Reabilitacao HCFMUSP
Study officials:
affiliation: Instituto de Medicina Física e Reabilitação HCFMUSP
name: Marta Imamura, MD
role: PRINCIPAL_INVESTIGATOR
References: