An observational study in Stroke, sponsored by Carmeli Eli. Completed at 1 site in Israel. Open to participants aged 30 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-06.
Sponsored by Carmeli Eli · Observational
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.
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
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 57 is below the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →This is the only study on the registry with Carmeli Eli as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Cohort will be selected from Fliman Rehabilitation Geriatric Center. Healthy subjects, age and gender-matched will be served as a control group.
Exclusion Criteria:
Stroke patients at the subacute phase
Other: stroke
healthy age-matched voluntiers
Other: Healthy controls
task-oriented therapy: physical and occupational therapy emphasizing integration of the patients needs, environment and context
no treatment
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.
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
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.
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.
% 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.
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...
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...
| Milestone | Patients After a Stroke | Control |
|---|---|---|
| Started | 38 | 19 |
| Recruited | 38 | 19 |
| Completed | 25 | 19 |
| Not completed | 13 | 0 |
| Withdrew: Lost to follow-up | 13 | 0 |
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.
| units on a scale | Study Group (T1) | Control |
|---|---|---|
| Fugl-Meyer assessment score (T1) | 38.32 ± 13.77 | NA ± NA |
| Fugl-Meyer assessment score (T2) | 47.6 ± 11.06 | NA ± NA |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
| seconds | Stroke | Healthy Controls |
|---|---|---|
| Deltoid T1 assessment | 1.33 ± 0.7 | 0.79 ± 0.32 |
| Deltoid T2 assessment | 0.9 ± 0.38 | NA ± NA |
| Trapezius T1 assessment | 1.09 ± 0.46 | 0.79 ± 0.3 |
| Trapezius T2 assessment | 0.8 ± 0.36 | NA ± NA |
| Biceps T1 assessment | 1.37 ± 0.7 | 0.79 ± 0.31 |
| Biceps T2 assessment | 0.82 ± 0.4 | NA ± NA |
| TricepsT1 assessment | 0.91 ± 0.81 | 0.72 ± 0.64 |
| Triceps T2 assessment | 1.12 ± 0.74 | NA ± NA |
T1 at the beginning of the hospital stay and folloew up at T2 one month later.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over THere were no adverse events in the study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study | — | 0/57 (0%) | 0/57 (0%) |
groups were matched by age (p\>0.1)
| Age, Categorical(Participants) | Study | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 3 | 7 |
| >=65 years | 34 | 16 | 50 |
| Age, Continuous(years) | Study | Control | Total |
|---|---|---|---|
| Mean | 75.15 ± 8.69 | 71 ± 10.58 | 74 ± 9.4 |
| Sex: Female, Male(Participants) | Study | Control | Total |
|---|---|---|---|
| Female | 13 | 11 | 24 |
| Male | 25 | 8 | 33 |
| Region of Enrollment(participants) | Study | Control | Total |
|---|---|---|---|
| Israel | 38 | 19 | 57 |
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.