Radial Shock Waves for Functional Disability in Stroke

Recruiting

Phase 2 Results N/A

Trial Description

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

Interventions

  • Active Radial Shockwave Device
    Intervention Desc: Four weekly sessions of active radial shockwave treatment.
    ARM 1: Kind: Experimental
    Label: Active Radial Shockwave
    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.
  • Sham Radial Shockwave Device
    Intervention Desc: Four weekly sessions of sham radial shockwave treatment.
    ARM 1: Kind: Experimental
    Label: Sham Radial Shockwave
    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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Assessment (FMA) change at 4 weeks Change from baseline at 4 weeks No
Secondary Visual Analogue Scale (VAS) Baseline, one and two months No
Secondary Esthesiometry - Von Frey Scale Baseline, one and two months No
Secondary Upper Limb Modified Ashworth Scale (MAS) Baseline, one week, two weeks, three weeks, four weeks and two months No
Secondary Fugl-Meyer Assessment Baseline and two months Yes
Secondary Medical Research Council scale (MRC) Baseline, one and two months No
Secondary Hand grip Baseline, one and two months No
Secondary Change in fine motor function measured with Finger Tapping (FT) Baseline, one and two months No
Secondary Jebsen-Taylor Hand Function Test (JTHFT) Baseline, one and two months No
Secondary Purdue Pegboard Test (PPBT) Baseline, one and two months No
Secondary Robotic kinematic evaluation (RKE) Baseline, one and two months No
Secondary Corticospinal excitability measures with transcranial magnetic stimulation (TMS) Baseline, one and two months No
Secondary Pinch strength testing Baseline, one and two months No

Sponsors