Radial Shock Waves for Functional Disability in Stroke

NCT02924168 | Completed DMC

• 1 other identifier: 19109813.1.0000.0068
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Visual Analogue Scale (VAS)

  Baseline, one and two months

• Esthesiometry - Von Frey Scale

  Baseline, one and two months

• Upper Limb Modified Ashworth Scale (MAS)

  Baseline, one week, two weeks, three weeks, four weeks and two months

• Fugl-Meyer Assessment

  Baseline and two months

• Medical Research Council scale (MRC)

  Baseline, one and two months

Other Outcomes (1)

• Adverse Events (AE)

  Weekly for two months

Study Arms (2)

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.

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.

Device: Sham Radial Shockwave

Interventions

Active Radial Shockwave DEVICE

Four weekly sessions of active radial shockwave treatment.

Active Radial Shockwave

Sham Radial Shockwave DEVICE

Four weekly sessions of sham radial shockwave treatment.

Sham Radial Shockwave

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical and radiological diagnosis: Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan indicating Stroke in the territory of the middle cerebral artery;
• to 24 months after stroke date;
• Stability observed in clinical medical evaluation
• Granting of written informed consent to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Marta Imamura: lead

Study Sites (1)

Instituto de Medicina Fisica e Reabilitacao HCFMUSP

São Paulo, 04116-030, Brazil

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marta Imamura, MD

  Instituto de Medicina Física e Reabilitação HCFMUSP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: October 5, 2016
• Study Start: September 1, 2013
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: June 7, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)