Clinical trial NCT02092662: Objective Assessment of Upper Extremity Functioning of Stroke Patients Before and After Rehabilitation
Official title: Objective Assessment of Upper Extremity Functioning of Stroke Patients Before and After Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2014-03-20
Enrollment: 57
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort will be selected from Fliman Rehabilitation Geriatric Center. Healthy subjects, age and gender-matched will be served as a control group.

Brief summary: The purpose of this study is to evaluate by objective measures the improvement in upper extremity functioning, as reflection of motor learning, in stroke patients in the sub acute phase. The investigators hypothesize that the improvements in daily functioning are partially due to compensation strategies and partially due to motor learning.

Detailed description: Background: Most stroke patients continue to suffer from upper extremity motor deficiencies even after prolonged and intense rehabilitation in hospital. Even though guidelines and other studies recommend to apply a rehabilitation programs as patient reception. As opposed to that there is a scarce evidence for the efficacy of the rehabilitation.

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

Eligibility criteria: Inclusion Criteria:

* diagnosis of cerebral stroke with upper extremity hemiparesis
* Ability to understand simple orders

Exclusion Criteria:

* Other orthopedic pathology
* Apraxia
* Bilateral Paresis
* Other neurologic pathology
* sensory aphasia

Primary outcomes:
measure: Fugl-Meyer Assessment.
timeFrame: T1 at the beginning of the hospital stay and folloew up at T2 one month later.
measure: Muscle Onset Time.
timeFrame: the study group was assessed T1 at the beginning of the hospital stay and follow up at T2 one month later. The control group assessed for the the time onset and compared to the study group at T1
Secondary outcomes:
measure: Muscle Co-activation Index.
timeFrame: T1 at the beginning of the hospital stay and folloew up at T2 one month later.
measure: Handwriting Velocity
timeFrame: T1 at the beginning of the hospital stay and follow up at T2 one month later.
measure: % Maximum Voluntary Contraction.
timeFrame: The outcome will be measured twice. First at the beginning of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average.
measure: Handwriting Pressure.
timeFrame: T1 at the beginning of the hospital stay and folloew up at T2 one mont...
measure: Handwriting Off-paper Time.
timeFrame: T1 at the beginning of the hospital stay and folloew up at T2 one mont...
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Fliman Geriatric Rehabilitation Center
Study officials:
affiliation: Fliman Geriatric Rehabilitation Center
name: Emanuel Markovich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Haifa
name: Sharon Israely, MSc.
role: STUDY_DIRECTOR
affiliation: University of Hifa
name: Eli Carmeli, PhD.
role: STUDY_CHAIR
References: