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Clinical Trial Summary

The general objective of this study was to evaluate the efficacy of the comprehensive protocol in improving post-stroke upper limb spasticity. The specific objectives were to evaluate pain improvement and changes in quality of life and functional capacity in patients who were subjected to the comprehensive protocol compared with those in the patients who underwent sham interventions.


Clinical Trial Description

Background: Managing post-stroke upper limb spasticity is a major challenge in the rehabilitation field. The objective of this study was to evaluate the efficacy of a comprehensive treatment protocol with four therapeutic modalities in the recovery of patients with chronic stroke by evaluating clinical, neurological and functional outcomes. Methodology: Thirty-two subjects diagnosed with a stroke at least six months prior to the study were randomized to receive ten sessions of either the treatment protocol or a sham intervention. The treatment protocol consisted of transcranial low-frequency electrical stimulation using subcutaneous needles over the scalp, paraspinous blocks, spastic muscle needling and functional electrical stimulation. Spasticity, range of motion, pain, functionality and quality of life were evaluated. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05940805
Study type Interventional
Source University of Sao Paulo General Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date November 3, 2019
Completion date December 3, 2023

See also
  Status Clinical Trial Phase
Completed NCT00432666 - IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Post-stroke Spasticity of the Upper Limb Phase 3
Completed NCT05382767 - Safety and Efficacy of CKDB-501A in Subjects With Post-stroke Upper Limb Spasticity Phase 1
Completed NCT03131791 - Comparing the Radial Extracorporeal Shock Waves and Botulinum Toxin Injection for Spasticity N/A