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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 October 2016 |
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Main ID: |
NCT02714478 |
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Date of registration:
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10/03/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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"Equistasi" and Gait in Hemiparesis
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Scientific title:
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Efficacy of "Equistasi" on the Gait of Patients Affected by Hemiparesis Due to Cerebrovascular Accident |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02714478 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Italy
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Contacts
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Name:
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Giuseppe Frazzitta, MD |
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Address:
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Telephone:
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+39033492705 |
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Email:
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frazzittag62@gmail.com |
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Affiliation:
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Name:
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Giuseppe Frazzitta, MD |
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Address:
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Telephone:
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+39033492705 |
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Email:
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frazzittag62@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- subacute hemiparesis
- Functional Ambulation Classification <4
Exclusion Criteria:
- previous neurological deficits
- Glasgow Coma Scale <13
- Complete sensory deficit in the lower limbs
- Levels of Cognitive Functioning =5
- polyneuropathy
- contraindications to mobilization/verticalization
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hemiparesis
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Intervention(s)
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Device: equistasi
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Device: placebo
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Primary Outcome(s)
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disability change assessed using Functional Independence Measure scale
[Time Frame: 0. 30. 60. 120 days]
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gait pattern change assessed using Functional Ambulation Classification scale
[Time Frame: 0. 30. 60. 120 days]
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balance change assessed using Berg Balance Scale
[Time Frame: 0. 30. 60. 120 days]
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gait speed change assessed using 10 meter walking test scale
[Time Frame: 0. 30. 60. 120 days]
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swaying of the center of gravity change assessed with stabilometric platform indexes
[Time Frame: 0. 30. 60. 120 days]
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gait speed change assessed using Timed Up and Go scale
[Time Frame: 0. 30. 60. 120 days]
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gait pattern change using Tinetti scale for gait
[Time Frame: 0. 30. 60. 120 days]
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Secondary ID(s)
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Equistasi.01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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