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| Name | Class |
|---|---|
| Tel Aviv University | OTHER |
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The purpose of this study is to investigate learning transfer from the healthy hand to the paretic hand in stroke patients. EMG signals from the healthy hand - while performing wrist dorsi flexion movement - will be used to activate electric muscles stimulation of the dorsi flexors of the paretic hand.
14 post-stroke subjects will be recruited from neurological rehabilitation department at Loewenstein rehabilitation hospital, Ra'anana, Israel. The patients will be randomly assigned to one of two groups: 1) Experimental group. 2) Control group. The 3 weeks intervention (15 sessions) in each group will include electric muscles stimuli (pulse rate 35-100Hz pulse width 200 microseconds, 5 sec on and 10 sec rest ) of the hemiparetic hand for 15 minutes. The patients in the experimental group will wear a wireless Bluetooth EMG ("Myo" bracelet) on their healthy forearm and when they will execute wrist dorsi flexion, the data will be transmitted to a PC which will be used to activate (via Arduino controller) a Transcutaneous Electric Nerve Stimulator (TENS) that is attached to the paretic dorsi flexors (electrodes are placed on the paretic forearm). The control group will get only automatic stimuli on the paretic forearm via the TENS.
The assessments will be done before the intervention, at the end of three weeks of intervention, and after 1 month from the end of the intervention (follow up).
The outcomes will include: active range of motion of fingers and wrist dorsi flexion (using cybermin 5DT glove for digital measures), upper limb section of Fugl-Meyer test, Box and Blocks test and Jebsen Taylor Hand Function Test. Only before the beginning of the intervention the sensory ability of the patient will be assessed using the Sensory section of Fugl-Meyer (FM) and Semmes-Weinstein filaments for superficial sensation. Normalized lesion data will be computed using the ABLE module within MEDx software (Medical Numerics).
Differences between groups will be calculated using t-tests or Mann-Whitney, depending on distribution of normality with corrections for multiple comparisons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMG and TENS | Experimental | Wireless Bluetooth EMG ("Myo") bracelet will be placed on the healthy forearm. A voluntary dorsi flexion of the healthy wrist produces data that will be transmitted to a PC and will be used to activate (via Arduino controller) a Transcutaneous Electric Nerve Stimulator (TENS), placed on the paretic forearm, that will stimulate wrist dorsi flexors. 5 days per week, for 3 weeks, 15 minutes per day. |
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| TENS only | Active Comparator | Custom-built software & hardware: PC + Arduino controller and Transcutaneous Electric Nerve Stimulator (TENS) device, will be used to stimulate wrist dorsi flexors of the paretic forearm. 5 days per week, for 3 weeks, 15 minutes per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMG and TENS | Device | Healthy hand EMG signal measured while making voluntarily wrist dorsi flexion will activate TENS, which will be placed on the paretic forearm and will produce wrist dorsi flexion. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in active range of motion of wrist dorsi flexion and fingers extension | The ability of the paretic hand to produce active range of motion (ROM) of paretic fingers and wrist by using digital measurements with 5DT Cybermin glove. | Baseline, after 3 weeks of intervention and one month after the end of the intervention (follow up). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fugl-Meyer Assessment | Score of 66 point indicate normal motor functioning of upper limb | Baseline, after 3 weeks of intervention and one month after the end of the intervention (follow up). |
| Change in Box and Blocks test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silvi Frenkel-Toledo | Contact | 972545509413 | silvi197@bezeqint.net | |
| Nachum Soroker, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Sivi Frenkel-Toledo, PhD | Loewenstein Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loewenstain hospital | Recruiting | Raanana | Israel |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004576 | Electromyography |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004568 | Electrodiagnosis |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009213 | Myography |
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| TENS only | Device | Automatic TENS stimuli to the paretic dorsi flexors (i.e., producing wrist dorsi flexion). |
|
Number of cubes transferred from one side of cube (chamber) to the other side of the cube within a minute
| Baseline, after 3 weeks of intervention and one month after the end of the intervention (follow up). |
| Change in Jebsen Taylor Hand Function Test | Time of performance of different task, mimicking activity of daily living, is measured. | Baseline, after 3 weeks of intervention and one month after the end of the intervention (follow up). |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004599 |
| Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |