Objective Assessment of Upper Extremity Functioning of Stroke Patients Before and After Rehabilitation
NCT ID: NCT02092662
Last Updated: 2015-08-06
Study Results
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View full resultsBasic Information
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COMPLETED
57 participants
OBSERVATIONAL
2014-01-31
2015-05-31
Brief Summary
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Detailed Description
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Objectives: To evaluate by objective measures the improvement in motor performance of the upper extremity of stroke patients in the sub acute period. Secondary objective is to describe the correlation between proximal and distal motor deficiencies of the upper extremity.
Hypothesis: Patients will show better hand performance at the end of hospitalization. Part of it can be attributed to the rehabilitation and part to a spontaneous recovery. Correlation will be found for proximal and distal upper extremity motor deficiencies.
Methods:
Trial began only after the IRB research approval. All treatment sessions will implemented by the physical and occupational staff of the hospital. Assessments for the measures will be carry out by a certified physical therapist which is coinvestigator. The coinvestigator collect the raw data for analysis in Excel and than in SPSS.
20 stroke patients who meet the inclusion criteria will participate in the study, after signing an informed consent.Patients will undergo the first assessment of all measures, e.g: motor abilities by Fugl-Meyer test, handwriting kinematic and kinetic measures and surface electromyography for measurement of muscle synergy.Patients will be treated by standard rehabilitation of physical and occupational therapy for a period of 3-4 weeks. Before discharge from hospital patients will undergo another assessment of all measures, in order to evaluate the progression in their upper limb motor abilities from reception. Part of the patients will be assessed again two to three weeks after discharge as follow up.
Outcome Measures: upper limb Fugl-Meyer assessment, handwriting Air-time, pressure and velocity, EMG (i.e., muscle onset, muscle amplitude, muscle co-activation ratio).
Statistical analysis: ANOVA analysis will be used to measure time effect. Correlation between measures will be measured by Pearson's correlation. Sample size (n=20) was calculated based on 5 points improvement in Fugl-Meyer test as minimal significant change with power of 0.8 and p-level under 0.05 for significance.
Key words: Stroke, Muscle synergy, Handwriting, Fugl-Meyer
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Stroke
Stroke patients at the subacute phase
stroke
task-oriented therapy: physical and occupational therapy emphasizing integration of the patients needs, environment and context
Healthy controls
healthy age-matched voluntiers
Healthy controls
no treatment
Interventions
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stroke
task-oriented therapy: physical and occupational therapy emphasizing integration of the patients needs, environment and context
Healthy controls
no treatment
Eligibility Criteria
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Inclusion Criteria
* Ability to understand simple orders
Exclusion Criteria
* Apraxia
* Bilateral Paresis
* Other neurologic pathology
* sensory aphasia
30 Years
90 Years
ALL
Yes
Sponsors
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Carmeli Eli
OTHER
Responsible Party
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Carmeli Eli
Professor
Principal Investigators
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Emanuel Markovich, MD
Role: PRINCIPAL_INVESTIGATOR
Fliman Geriatric Rehabilitation Center
Sharon Israely, MSc.
Role: STUDY_DIRECTOR
University of Haifa
Eli Carmeli, PhD.
Role: STUDY_CHAIR
University of Hifa
Locations
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Fliman Geriatric Rehabilitation Center
Haifa, Israel, Israel
Countries
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Other Identifiers
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UHai920130001
Identifier Type: -
Identifier Source: org_study_id
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