Radial Shock Waves for Functional Disability in Stroke

Ischemic Stroke Clinical Trial

Official title:

Effect of Radial Shock Waves for the Treatment of Upper Limb Functional Disability in Stroke Sequelae

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02924168
• Other study ID #: 19109813.1.0000.0068
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: February 2018

Study information

• Verified date: June 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Device:
• Active Radial Shockwave
Four weekly sessions of active radial shockwave treatment.
• Sham Radial Shockwave
Four weekly sessions of sham radial shockwave treatment.

Locations

Country	Name	City	State
Brazil	Instituto de Medicina Fisica e Reabilitacao HCFMUSP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Marta Imamura

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events (AE)	Accountability of occurences of Adverse Events	Weekly for two months
Primary	Fugl-Meyer Assessment (FMA)	Mean change in Fugl Meyer Assessment score after four sessions of Radial Shockwave Therapy (RSWT) as compared to baseline.	Change from baseline to 8 weeks
Secondary	Visual Analogue Scale (VAS)	Multiple changes in VAS	Baseline, one and two months
Secondary	Esthesiometry - Von Frey Scale	Multiple changes in Von Frey Scale	Baseline, one and two months
Secondary	Upper Limb Modified Ashworth Scale (MAS)	Multiple changes in MAS	Baseline, one week, two weeks, three weeks, four weeks and two months
Secondary	Fugl-Meyer Assessment	Changes in Fugl-Meyer Assessment compared to baseline	Baseline and two months
Secondary	Medical Research Council scale (MRC)	Multiple changes in MRC scale	Baseline, one and two months
Secondary	Hand grip	Multiple changes in Hand grip	Baseline, one and two months
Secondary	Change in fine motor function measured with Finger Tapping (FT)	Multiple changes in FT	Baseline, one and two months
Secondary	Jebsen-Taylor Hand Function Test (JTHFT)	Multiple changes in JTHFT	Baseline, one and two months
Secondary	Purdue Pegboard Test (PPBT)	Multiple changes in PPBT	Baseline, one and two months
Secondary	Robotic kinematic evaluation (RKE)	Multiple changes in RKE	Baseline, one and two months
Secondary	Corticospinal excitability measures with transcranial magnetic stimulation (TMS)	Multiple changes in Corticospinal excitability	Baseline, one and two months
Secondary	Pinch strength testing	Pinch strength testing	Baseline, one and two months