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The objective of the present trial is to demonstrate Magnetic stimulation as an useful complementary treatment in order to improve patients' evolution without the need of extensive surgical lesion.
Patients with refractory post stroke upper right limb spasticity will operated by Median nerve or Median/ Cubital selective neurotomy depending upon more affected territories.
Some of them could be also also operated with posterioris tibialis neurotomy to treat equine's foot whenever also clinically present. Preoperative motor blocks might be possitive in all cases.
A week later, they will be treated by magnetic stimulation on selected antagonistic muscles, related to pre - operative affected ones, mostly deltoids, triceps and finger extensors with an equipment Dipol Zeta D5 (Russian Federation), with 1.5 tesla of intensity.
Trials will be repeated twice a week in sessions of 30 minutes during 6 months with simultaneous intensive classic rehabilitation.
Patients will be monthly evaluated by the mean score of Modified Ashworth Scale, related to fingers, wrist, elbow and shoulder and also with Barthel Scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kinesics | Sham Comparator | - Classic Rehabilitation and Kinesic Therapy |
|
| surgery | Sham Comparator | - Surgery: Selective Peripheral Neurotomy is surgical a method of section on suplying peripheral nerves of motor fascicles to relieve harmful spasticity. An intraoperative stimulation of motor fascicles is done, and those which abnormal spreading on far placed myotomes are more evident are chosen to be sectioned. |
|
| Magnetic Stimulation | Active Comparator | - Postoperative Antagonistic Peripheral Magnetic Stimulation with 1.5 tesla intensity, infrathreshold 80 per cent of minimal intensity able to produce always muscle contraccion. Trials repeated twice a week in sessions of 30 minutes during 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| - Postoperative Antagonistic Peripheral Magnetic Stimulation | Procedure | Selected patients will be treated with Selective peripheral Neurotomy followed by an standartized cycle of Selective Peripheral Magnetic Stimulation and classic post operative Kinesic Therapy.
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Ashworth Scale (MAS) | - Mean Preoperative and sequencial monthly postoperative evaluation of stiffness and ranges of joint pasive movements at the shoulder, elbow, wrist and fingers. | Post operative Modified Ashworth Scale /MAS) setted up monthly for each patient taking into account the postoperative date, during six continued months. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl - Meyer Scale | Pre and post operative evaluation of a set of active and pasive movements and articular angles in the upper limb | Post operative Fugl - Meyer Scale evaluation, setted up monthly for each patient taking into account the postoperative date, during six continued months. |
| Barthel Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Carlos Mario Andreani, MD | Contact | 91150531392 | jcmandreani@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Juan Carlos Mario Andreani, MD | FundaciĂłn CENIT | Study Director |
| Fabián César Piedimonte, MD | Fundación CENIT - President | Principal Investigator |
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|
|
| Selective Peripheral Magnetic Stimulation | Device | Peripheral 1.5 tesla intensity, 10 Hz of Frequency, with "eight saped" bovine, of 30 minutes, aplied on antagonistic muscles, twice a week. Intensity will be infrathreshold, 80 per cent of the individual threshold (minimal amount of intensity producing always a muscle motor response in each particular patient) |
|
| Kinesics | Other | Session of classic Kinetic Rehabilitation and motor exercises, twice a week on Physicians´s office and dayly on patient´s home. |
|
|
Pre and post operative evaluation of ten basic current dayly life activities, scored 10, 5 or 0 points each one, a total of 100 points |
| Post operative Barthel Scale evaluation setted up monthly for each patient taking into account the postoperative date, during six continued months. |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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