Status:

RECRUITING

Dynamic Perturbation Training for Home-Based Upper Limb Rehabilitation in Chronic Stroke

Lead Sponsor:

University Hospital of Ferrara

Collaborating Sponsors:

Università degli Studi di Ferrara

Conditions:

Stroke

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Study procedures: After acquiring clinical-demographic, neurophysiological and clinical-functional data to describe the extent of upper limb impairment at baseline at the facilities of the Rehabilitat...

Eligibility Criteria

Inclusion

  • Males and females aged 18 years or older;
  • Diagnosis of first cerebral stroke (ischaemic or haemorrhagic) in the chronic phase (i.e. at least 6 months after the onset of the acute event) verified by brain imaging (brain computed tomography and/or magnetic resonance imaging);
  • Motor deficit in the upper limb - and in particular in the hand - caused by stroke, not attributable to other conditions or diseases and not such as to preclude the ability to perform movements with the fingers and to perform movements to grasp objects;
  • Ability to express informed consent correctly.
  • Availability of a webcam and Internet connection at home for remote supervision of activities by the staff involved in the study.

Exclusion

  • Medical conditions that may interfere with the ability to safely complete the study protocol;
  • Cognitive dysfunction that precludes informed consent;
  • Severe neuropsychological disorders;
  • Severe visual problems;
  • Upper limb pain assessed with Visual Analogue Scale (VAS) \> 7;
  • Severe internal diseases (e.g. cardiopulmonary, renal, hepatic);
  • Diseases with inflammatory skin lesions, wounds, sensory and circulatory disorders below the elbow and on the hand in the area of application;
  • Contraindications to transcranial magnetic stimulation (TMS) procedures, assessed as indicated by international reference, such as: presence of intracranial metal implants, positive history of epilepsy, frequent migraines, implantable devices (ventricular-peritoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants). It should be noted that the presence of this type of exclusion criterion will preclude the performance of TMS assessments, but not the remaining procedures of the study;
  • Pregnancy.

Key Trial Info

Start Date :

March 15 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2027

Estimated Enrollment :

52 Patients enrolled

Trial Details

Trial ID

NCT06992700

Start Date

March 15 2025

End Date

June 1 2027

Last Update

May 28 2025

Active Locations (1)

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Ferrara University Hospital

Ferrara, Emilia-Romagna, Italy, 44124