Status:

COMPLETED

Repetitive Arm Training + FES on Upper Extremity Motor Recovery in Sub-acute Stroke Survivors

Lead Sponsor:

University Hospital of Ferrara

Conditions:

Stroke

Arm Motor Recovery

Eligibility:

All Genders

18-79 years

Phase:

NA

Brief Summary

Rehabilitation restores functions and reduces disabilities due to diseases sequelae. The relationship between intensity of rehabilitation and clinical outcomes, recently emphasized, has generated a gr...

Detailed Description

Primary endpoint: Fugl-Meyer Upper Extremity (FM-UE) Secondary endpoints: Box and Block Test (BBT), Modified Ashworth Scale (MAS); motor cortex excitability (TMS); Electromyography analysis of muscle ...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • males and females, age 18 to 79 years
  • diagnosis of first, single unilateral ischemic stroke verified by brain imaging \< 8 weeks
  • upper limb motor function defined by an FM-UE score \> 11 and \<55
  • Exclusion criteria:
  • medical conditions likely to interfere with the ability to safely complete the study protocol
  • impaired cognitive functioning: score less than 24 on the Mini Mental Status Examination (MMSE)
  • severe upper-limb pain, referred as \> 7 at Visual Analog Scale (VAS)
  • history of seizures or epilepsy

Exclusion

    Key Trial Info

    Start Date :

    September 1 2013

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2016

    Estimated Enrollment :

    64 Patients enrolled

    Trial Details

    Trial ID

    NCT02267798

    Start Date

    September 1 2013

    End Date

    November 1 2016

    Last Update

    February 3 2017

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Physical Medicine and Rehabilitation Department Ferrara

    Ferrara, Emilia-Romagna, Italy, 44100

    2

    Ferrara University Hospital

    Ferrara, Ferrara, Italy, 44124