Objective Assessment of Upper Extremity Functioning of Stroke Patients Before and After Rehabilitation

Stroke Clinical Trial

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Official title:

Objective Assessment of Upper Extremity Functioning of Stroke Patients Before and After Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092662
• Other study ID #: UHai920130001
• Status: Completed
• Phase: N/A
• First received: March 12, 2014
• Last updated: July 7, 2015
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: University of Haifa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• stroke
task-oriented therapy: physical and occupational therapy emphasizing integration of the patients needs, environment and context
• Healthy controls
no treatment

Locations

Country	Name	City	State
Israel	Fliman Geriatric Rehabilitation Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmeli Eli

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment.	zero to 66 points scale, measuring the impairment level of the upper extremity. Zero indicates a high level of impairment or minimum hand motor function, while 66 points indicates an increased motor function which is similar to normal upper extremity function.	T1 at the beginning of the hospital stay and folloew up at T2 one month later.	No
Primary	Muscle Onset Time.	Assessed by surface electromyography device. The time period it takes the muscle to be activated and contract from a voice prompting is measured. Shorter time onset probably charcterized healthy people compared to patients after a stroke.	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	No
Secondary	Muscle Co-activation Index.	Assessed by surface electromyography device. Indicate for the level by which muscles contract at the same time and amplitude. It will be calculated in percentage from 100%, as 100% indicate for complete co-activation between a pair of muscles.	T1 at the beginning of the hospital stay and folloew up at T2 one month later.	No
Secondary	Handwriting Velocity	Assessed by electronic tablet with specific software called ComPET. Patient make writing tasks. The velocity of his writing is measured and pass from the tablet to the computer to be processed by the software.	T1 at the beginning of the hospital stay and follow up at T2 one month later.	No
Secondary	% Maximum Voluntary Contraction.	T1 at the beginning of the hospital stay and folloew up at T2 one month later.	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.	No
Secondary	Handwriting Pressure.	Assessed by electronic tablet with specific software called ComPET. Patient make writing tasks, and the pressure exerted with the pen on the tablet is recorded. The data from the tablet passed to the computer to be processed by the software.	T1 at the beginning of the hospital stay and folloew up at T2 one mont...	No
Secondary	Handwriting Off-paper Time.	Assessed by electronic tablet with specific software called ComPET. Patient make writing tasks. The time the pen is on air is measured. The data from the tablet passed to the computer to be processed by the software.	T1 at the beginning of the hospital stay and folloew up at T2 one mont...	No