Combined Antagonistic Muscle Magnetic Stimulation and Selective Periferal Neurotomy to Improve Results on Spasticity

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Use of Antagonistic Muscle Magnetic Stimulation to Avoid Extensive Lesions and Improve Results of Selective Peripheral Neurotomy on Refractory and I POost Stroke Spasticity With Exclusive or Predominant Right Upper Limb Arm

Conditions
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STROKE

Intervention / Treatment
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* Procedure: - Postoperative Antagonistic Peripheral Magnetic Stimulation
* Device: Selective Peripheral Magnetic Stimulation
* Other: Kinesics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe and refractory right Hemiparesia or Hemiplegia, affecting hand function. Failure of kinesic treatment 2 points or more Improvement on Modified Ashworth Scale after anestethic blockade Exclusion Criteria: Severe cardiovascular disease Severe pulmonary disease Neoplasia advanced disease Joint anchylosis Irreversible retraction for muscle fibrosis

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Kinesics<br>- Classic Rehabilitation and Kinesic Therapy | Procedure: - Postoperative Antagonistic Peripheral Magnetic Stimulation<br>* 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. Sham patients (n 10) will be treated with classic post operative Kinesic Therapy. Comparision of both groups will be statistified<br>* Other names: - Kinesic Rehabilitation Therapy;Other: Kinesics<br>* Session of classic Kinetic Rehabilitation and motor exercises, twice a week on Physicians´s office and dayly on patient´s home.<br>* Other names: Classic Rehabilitation Treatment;|
| Sham Comparator: surgery<br>- 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. | Procedure: - Postoperative Antagonistic Peripheral Magnetic Stimulation<br>* 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. Sham patients (n 10) will be treated with classic post operative Kinesic Therapy. Comparision of both groups will be statistified<br>* Other names: - Kinesic Rehabilitation Therapy;Other: Kinesics<br>* Session of classic Kinetic Rehabilitation and motor exercises, twice a week on Physicians´s office and dayly on patient´s home.<br>* Other names: Classic Rehabilitation Treatment;|
| Active Comparator: Magnetic Stimulation<br>- 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 | Procedure: - Postoperative Antagonistic Peripheral Magnetic Stimulation<br>* 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. Sham patients (n 10) will be treated with classic post operative Kinesic Therapy. Comparision of both groups will be statistified<br>* Other names: - Kinesic Rehabilitation Therapy;Device: Selective Peripheral Magnetic Stimulation<br>* 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)<br>Other: Kinesics<br>* Session of classic Kinetic Rehabilitation and motor exercises, twice a week on Physicians´s office and dayly on patient´s home.<br>* Other names: Classic Rehabilitation Treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Barthel Scale, Disability, Modified Ashworth Scale, Right Arm, Neuromodulation, Spasticity, Stroke