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Clinical Trials/NCT01828398
NCT01828398
Completed
Phase 2

tDCS and Robotic Therapy in Stroke

University Hospital of Ferrara1 site in 1 country40 target enrollmentNovember 2011
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ConditionsStrokeUpper Extremity Impairments

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Stroke
Sponsor
University Hospital of Ferrara
Enrollment
40
Locations
1
Primary Endpoint
Fugl-Meyer Upper Extremity
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

After stroke a limited motor recovery in the paretic upper limb accounts for a large proportion of the disabling sequelae. Only about 15% of those with initial complete upper limb paralysis after stroke recover functional use of their impaired arm in daily life.

The aim of this study is to test the effects of tDCS combined with upper extremity robot-assisted therapy on stroke survivors.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
November 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital of Ferrara
Responsible Party
Principal Investigator
Principal Investigator

Sofia Straudi, MD

MD

University Hospital of Ferrara

Eligibility Criteria

Inclusion Criteria

  • •Males and females subjects. Age \> 18 years.
  • •Diagnosis of first ischemic stroke
  • •Impairment of the upper limb
  • •Trunk control defined in the Trunk-Control Test (TCT), with a score \> 50.

Exclusion Criteria

  • •anyone who does not have adequate understanding of verbal or written information in Italian sufficient to complete any test
  • •Impaired cognitive functioning: score less than 24 on the Mini Mental Status Examination (MMSE)
  • •contraindications to single-pulse transcranial magnetic stimulation (TMS)(TMS will be used to measure cortical excitability): presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants)
  • •Contraindications to tDCS: intracranial metal implants that can be stimulated, incorrectly positioned or over-heated by the electric current
  • •Neurological or psychiatric pathology
  • •severe cardio-pulmonary, renal, hepatic diseases
  • •Pregnancy

Outcomes

Primary Outcomes

Fugl-Meyer Upper Extremity

Time Frame: A week prior to treatment beginning

Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.

Secondary Outcomes

  • Assessment of cortical excitability (TMS)(A week prior to treatment beginning)
  • Box and Block Test(A week prior to treatment beginning)
  • Ashworth Modified Scale(A week prior to treatment beginning)
  • Motor Activity Log (MAL)(A week prior to treatment beginning)

Study Sites (1)

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