Radial Shock Waves for Functional Disability in Stroke

NCT ID: NCT02924168

Last Updated: 2018-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2018-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Active Radial Shockwave

Intervention Type: DEVICE

Four weekly sessions of active radial shockwave treatment.

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.

Group Type: SHAM_COMPARATOR

Sham Radial Shockwave

Intervention Type: DEVICE

Four weekly sessions of sham radial shockwave treatment.

Interventions

Active Radial Shockwave

Four weekly sessions of active radial shockwave treatment.

Intervention Type: DEVICE

Sham Radial Shockwave

Four weekly sessions of sham radial shockwave treatment.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marta Imamura

OTHER

Sponsor Role: lead

Responsible Party

Marta Imamura

MD PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marta Imamura, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Medicina Física e Reabilitação HCFMUSP

Locations

Instituto de Medicina Fisica e Reabilitacao HCFMUSP

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

19109813.1.0000.0068

Identifier Type: -

Identifier Source: org_study_id