Radial Shock Waves for Functional Disability in Stroke

Marta Imamura22 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Ischemic Stroke

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Fugl-Meyer Assessment (FMA)

Mean change in Fugl Meyer Assessment score after four sessions of Radial Shockwave Therapy (RSWT) as compared to baseline.

Time frame: Change from baseline to 8 weeks

Secondary Outcomes

Visual Analogue Scale (VAS)

Multiple changes in VAS

Time frame: Baseline, one and two months

Esthesiometry - Von Frey Scale

Multiple changes in Von Frey Scale

Time frame: Baseline, one and two months

Upper Limb Modified Ashworth Scale (MAS)

Multiple changes in MAS

Time frame: Baseline, one week, two weeks, three weeks, four weeks and two months

Fugl-Meyer Assessment

Changes in Fugl-Meyer Assessment compared to baseline

Time frame: Baseline and two months

Medical Research Council scale (MRC)

Multiple changes in MRC scale

Time frame: Baseline, one and two months

Hand grip

Multiple changes in Hand grip

Time frame: Baseline, one and two months

Change in fine motor function measured with Finger Tapping (FT)

Multiple changes in FT

Time frame: Baseline, one and two months

Jebsen-Taylor Hand Function Test (JTHFT)

Multiple changes in JTHFT

Time frame: Baseline, one and two months

Purdue Pegboard Test (PPBT)

Multiple changes in PPBT

Time frame: Baseline, one and two months

Robotic kinematic evaluation (RKE)

Multiple changes in RKE

Time frame: Baseline, one and two months

Corticospinal excitability measures with transcranial magnetic stimulation (TMS)

Multiple changes in Corticospinal excitability

Time frame: Baseline, one and two months

Pinch strength testing

Time frame: Baseline, one and two months

Radial Shock Waves for Functional Disability in Stroke

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes