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Studies

Interventional Recruiting

NCT05478434 on ClinicalTrials.gov

Cortico-cortical Stimulation and Robot-assisted Therapy for Upper Limb Recovery After Stroke (CCS&RAT)

Official title: Cortico-cortical Stimulation and Robot-assisted Therapy a New Approach of Upper Limb Functional Recovery After Stroke

  • Sponsor: Fondazione Santa Lucia
  • Collaborators: Università degli studi di Roma Foro Italico
  • Enrollment: 32 (Estimated)
  • Study start: 2022-08-21 (Actual)
  • Primary completion: 2025-08-01 (Estimated)
  • Study completion: 2025-10-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Randomised Clinical trial
  • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief Summary

The purpose of this study is to tested the effect of combination of a paired associative stimulation of two functional interconnected areas of the cerebral cortex (posterior-parietal cortex and primary motor cortex) with robot-assisted therapy in the recovery of upper limb after stroke.

Conditions

  • Stroke
  • Stroke, Ischemic

Intervention / Treatment

  • Device: Cortico-cortical stimulation plus robot-assisted therapy
  • Device: Sham cortico-cortical stimulation plus robot-assisted therapy

Primary Outcome Measures

  • Change in the Fugl-Meyer Assessment Scale for Upper Extremity (FMA-UE) (baseline; 3weeks (end of treatment); 7weeks (follow-up))
    Comprehensive clinical measurement tool of upper limb functions after stroke. Range score form 0 to 66 points, a higher score represents an improvement.

Countries

Italy

Locations and Investigators

  • Santa Lucia Foundation, Rome, Italy (Recruiting)
    • Sonia Bonnì, PhD
    • Giuseppe Vannozzi, Prof
    • Alex Martino Cinnera, MSc
    • Alessia D'Acunto, BSc

Study Officials