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Radial Shock Waves for Functional Disability in Stroke

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Active Radial Shockwave
Sham Radial Shockwave
Sponsored by
Marta Imamura
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto de Medicina Fisica e Reabilitacao HCFMUSP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active Radial Shockwave

Sham Radial Shockwave

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Visual Analogue Scale (VAS)
Multiple changes in VAS
Esthesiometry - Von Frey Scale
Multiple changes in Von Frey Scale
Upper Limb Modified Ashworth Scale (MAS)
Multiple changes in MAS
Fugl-Meyer Assessment
Changes in Fugl-Meyer Assessment compared to baseline
Medical Research Council scale (MRC)
Multiple changes in MRC scale
Hand grip
Multiple changes in Hand grip
Change in fine motor function measured with Finger Tapping (FT)
Multiple changes in FT
Jebsen-Taylor Hand Function Test (JTHFT)
Multiple changes in JTHFT
Purdue Pegboard Test (PPBT)
Multiple changes in PPBT
Robotic kinematic evaluation (RKE)
Multiple changes in RKE
Corticospinal excitability measures with transcranial magnetic stimulation (TMS)
Multiple changes in Corticospinal excitability
Pinch strength testing
Pinch strength testing

Full Information

First Posted
September 29, 2016
Last Updated
June 5, 2018
Sponsor
Marta Imamura
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1. Study Identification

Unique Protocol Identification Number
NCT02924168
Brief Title
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marta Imamura

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Radial Shockwave
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Radial Shockwave
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Active Radial Shockwave
Intervention Description
Four weekly sessions of active radial shockwave treatment.
Intervention Type
Device
Intervention Name(s)
Sham Radial Shockwave
Intervention Description
Four weekly sessions of sham radial shockwave treatment.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment (FMA)
Description
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 Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
Multiple changes in VAS
Time Frame
Baseline, one and two months
Title
Esthesiometry - Von Frey Scale
Description
Multiple changes in Von Frey Scale
Time Frame
Baseline, one and two months
Title
Upper Limb Modified Ashworth Scale (MAS)
Description
Multiple changes in MAS
Time Frame
Baseline, one week, two weeks, three weeks, four weeks and two months
Title
Fugl-Meyer Assessment
Description
Changes in Fugl-Meyer Assessment compared to baseline
Time Frame
Baseline and two months
Title
Medical Research Council scale (MRC)
Description
Multiple changes in MRC scale
Time Frame
Baseline, one and two months
Title
Hand grip
Description
Multiple changes in Hand grip
Time Frame
Baseline, one and two months
Title
Change in fine motor function measured with Finger Tapping (FT)
Description
Multiple changes in FT
Time Frame
Baseline, one and two months
Title
Jebsen-Taylor Hand Function Test (JTHFT)
Description
Multiple changes in JTHFT
Time Frame
Baseline, one and two months
Title
Purdue Pegboard Test (PPBT)
Description
Multiple changes in PPBT
Time Frame
Baseline, one and two months
Title
Robotic kinematic evaluation (RKE)
Description
Multiple changes in RKE
Time Frame
Baseline, one and two months
Title
Corticospinal excitability measures with transcranial magnetic stimulation (TMS)
Description
Multiple changes in Corticospinal excitability
Time Frame
Baseline, one and two months
Title
Pinch strength testing
Description
Pinch strength testing
Time Frame
Baseline, one and two months
Other Pre-specified Outcome Measures:
Title
Adverse Events (AE)
Description
Accountability of occurences of Adverse Events
Time Frame
Weekly for two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Imamura, MD
Organizational Affiliation
Instituto de Medicina Física e Reabilitação HCFMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Medicina Fisica e Reabilitacao HCFMUSP
City
Sao Paulo
ZIP/Postal Code
04116-030
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Radial Shock Waves for Functional Disability in Stroke

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