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Completed

NCT Number: NCT02924168

Radial Shock Waves for Functional Disability in Stroke

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Medicina Fisica e Reabilitacao HCFMUSP

São Paulo, 04116-030, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Radial Shockwave

Device

Four weekly sessions of active radial shockwave treatment.

Sham Radial Shockwave

Device

Four weekly sessions of sham radial shockwave treatment.

Primary outcomes

  1. Fugl-Meyer Assessment (FMA)

    Time frame: Change from baseline to 8 weeks

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

Secondary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: Baseline, one and two months

    Multiple changes in VAS

  2. Esthesiometry - Von Frey Scale

    Time frame: Baseline, one and two months

    Multiple changes in Von Frey Scale

  3. Upper Limb Modified Ashworth Scale (MAS)

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

    Multiple changes in MAS

  4. Fugl-Meyer Assessment

    Time frame: Baseline and two months

    Changes in Fugl-Meyer Assessment compared to baseline

  5. Medical Research Council scale (MRC)

    Time frame: Baseline, one and two months

    Multiple changes in MRC scale

  6. Hand grip

    Time frame: Baseline, one and two months

    Multiple changes in Hand grip

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

    Time frame: Baseline, one and two months

    Multiple changes in FT

  8. Jebsen-Taylor Hand Function Test (JTHFT)

    Time frame: Baseline, one and two months

    Multiple changes in JTHFT

  9. Purdue Pegboard Test (PPBT)

    Time frame: Baseline, one and two months

    Multiple changes in PPBT

  10. Robotic kinematic evaluation (RKE)

    Time frame: Baseline, one and two months

    Multiple changes in RKE

  11. Corticospinal excitability measures with transcranial magnetic stimulation (TMS)

    Time frame: Baseline, one and two months

    Multiple changes in Corticospinal excitability

  12. Pinch strength testing

    Time frame: Baseline, one and two months

    Pinch strength testing

Other outcomes

  1. Adverse Events (AE)

    Time frame: Weekly for two months

    Accountability of occurences of Adverse Events

Sponsors and collaborators

Lead sponsor

Marta Imamura

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Oct 5, 2016
Registry last updated
Jun 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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