Stroke
Conditions
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
Interventions
OTHERstroke
task-oriented therapy: physical and occupational therapy emphasizing integration of the patients needs, environment and context
OTHERHealthy controls
no treatment
Sponsors
Carmeli Eli
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment. | T1 at the beginning of the hospital stay and folloew up at T2 one month later. | 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. |
| Muscle Onset Time. | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| % Maximum Voluntary Contraction. | 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. | T1 at the beginning of the hospital stay and folloew up at T2 one month later. |
| Muscle Co-activation Index. | T1 at the beginning of the hospital stay and folloew up at T2 one month later. | 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. |
| Handwriting Off-paper Time. | T1 at the beginning of the hospital stay and folloew up at T2 one mont... | 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. |
| Handwriting Pressure. | T1 at the beginning of the hospital stay and folloew up at T2 one mont... | 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. |
| Handwriting Velocity | T1 at the beginning of the hospital stay and follow up at T2 one month later. | 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. |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study patients after a stroke | 38 |
| Control healthy volunteers | 19 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 0 |
Baseline characteristics
| Characteristic | Control | Study | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 34 Participants | 50 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 4 Participants | 7 Participants |
| Age, Continuous | 71 years STANDARD_DEVIATION 10.58 | 75.15 years STANDARD_DEVIATION 8.69 | 74 years STANDARD_DEVIATION 9.4 |
| Region of Enrollment Israel | 19 participants | 38 participants | 57 participants |
| Sex: Female, Male Female | 11 Participants | 13 Participants | 24 Participants |
| Sex: Female, Male Male | 8 Participants | 25 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 57 |
| serious Total, serious adverse events | 0 / 57 |
Outcome results
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.
Time frame: T1 at the beginning of the hospital stay and folloew up at T2 one month later.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Group (T1) | Fugl-Meyer Assessment. | Fugl-Meyer assessment score (T1) | 38.32 units on a scale | Standard Deviation 13.77 |
| Study Group (T1) | Fugl-Meyer Assessment. | Fugl-Meyer assessment score (T2) | 47.6 units on a scale | Standard Deviation 11.06 |
| Control | Fugl-Meyer Assessment. | Fugl-Meyer assessment score (T1) | NA units on a scale | — |
| Control | Fugl-Meyer Assessment. | Fugl-Meyer assessment score (T2) | NA units on a scale | — |
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Group (T1) | Muscle Onset Time. | Deltoid T1 assessment | 1.33 seconds | Standard Deviation 0.7 |
| Study Group (T1) | Muscle Onset Time. | Deltoid T2 assessment | 0.9 seconds | Standard Deviation 0.38 |
| Study Group (T1) | Muscle Onset Time. | Trapezius T1 assessment | 1.09 seconds | Standard Deviation 0.46 |
| Study Group (T1) | Muscle Onset Time. | Trapezius T2 assessment | 0.8 seconds | Standard Deviation 0.36 |
| Study Group (T1) | Muscle Onset Time. | Biceps T1 assessment | 1.37 seconds | Standard Deviation 0.7 |
| Study Group (T1) | Muscle Onset Time. | Biceps T2 assessment | 0.82 seconds | Standard Deviation 0.4 |
| Study Group (T1) | Muscle Onset Time. | TricepsT1 assessment | 0.91 seconds | Standard Deviation 0.81 |
| Study Group (T1) | Muscle Onset Time. | Triceps T2 assessment | 1.12 seconds | Standard Deviation 0.74 |
| Control | Muscle Onset Time. | Triceps T2 assessment | NA seconds | — |
| Control | Muscle Onset Time. | Deltoid T1 assessment | 0.79 seconds | Standard Deviation 0.32 |
| Control | Muscle Onset Time. | Biceps T1 assessment | 0.79 seconds | Standard Deviation 0.31 |
| Control | Muscle Onset Time. | Deltoid T2 assessment | NA seconds | — |
| Control | Muscle Onset Time. | TricepsT1 assessment | 0.72 seconds | Standard Deviation 0.64 |
| Control | Muscle Onset Time. | Trapezius T1 assessment | 0.79 seconds | Standard Deviation 0.3 |
| Control | Muscle Onset Time. | Biceps T2 assessment | NA seconds | — |
| Control | Muscle Onset Time. | Trapezius T2 assessment | NA seconds | — |
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.
Time frame: T1 at the beginning of the hospital stay and folloew up at T2 one mont...
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.
Time frame: T1 at the beginning of the hospital stay and folloew up at T2 one mont...
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.
Time frame: T1 at the beginning of the hospital stay and follow up at T2 one month later.
Secondary
% Maximum Voluntary Contraction.
T1 at the beginning of the hospital stay and folloew up at T2 one month later.
Time frame: 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.
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.
Time frame: T1 at the beginning of the hospital stay and folloew up at T2 one month later.