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Clinical Trials/NCT06755437
NCT06755437
Terminated
Not Applicable

Self Treatment With an Electronic Device for Cognitive Rehabilitation in Patients With Subacute Stroke: A Randomized Controlled Trial

Universita di Verona1 site in 1 country80 target enrollmentOctober 2, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Universita di Verona
Enrollment
80
Locations
1
Primary Endpoint
Trail Making Test Part A (TMT-A)
Status
Terminated
Last Updated
8 months ago

Overview

Brief Summary

The objective of this study is to evaluate whether the independent use of an electronic device by a patient with stroke outcomes can enhance the effectiveness of rehabilitative treatment for attentional functions compared to standard treatment.

Registry
clinicaltrials.gov
Start Date
October 2, 2017
End Date
July 31, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universita di Verona
Responsible Party
Principal Investigator
Principal Investigator

Valentina Varalta

Doctor

Universita di Verona

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of ischemic or hemorrhagic stroke
  • Within 2 weeks since stroke onset
  • Age under 85 years
  • Attention deficits as measured by the Trails task or the Broken Hearts subtest in the Oxford Cognitive Screen (OCS)
  • Exclusion criteria:
  • Visual impairment documented by clinical history (e.g., cataracts, diabetic retinopathy, glaucoma, hemianopia)
  • Uncompensated psychiatric disorders
  • Drug or alcohol abuse
  • History of dementia
  • Severe comprehension disorders as determined by the Semantics subtest in the Oxford Cognitive Screen (OCS)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Trail Making Test Part A (TMT-A)

Time Frame: From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment)

The Trail Making Test Part A (TMT-A) is a neuropsychological assessment that measures selective attention and processing speed. Participants connect a series of numbered circles in sequential order as quickly as possible. The score is determined by the time taken to complete the task, with shorter times indicating better performance. Errors may negatively impact the score.

Secondary Outcomes

  • Trail Making Test Part B (TMT-B)(From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment))
  • Dual task test(From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment))
  • short version of the Elithorn's Perceptual Maze Test(From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment))
  • Stroop Test(From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment))

Study Sites (1)

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