Combined Antagonistic Muscle Magnetic Stimulation and Selective Periferal Neurotomy to Improve Results on Spasticity "Andreani2"

Not yet recruiting

Phase N/A Results N/A

Trial Description

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

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.

Conditions

Interventions

  • - Postoperative Peripheral Magnetic Stimulation Procedure
    Other Names: - Preoperative Peripheral Nerve Blockade; - Selective Peripheral Neurotomy; - Kinesic Rehabilitation Therapy
    Intervention Desc: Sham patients (n 10) will be treated in a classic way with post operative Kinesic Rehabilitation Therapy. The other group will be treated the same way but adding Postoperative Peripheral Magnetic Stimulation. Comparision of both groups will be statistified
    ARM 1: Kind: Experimental
    Label: Motor function
    Description: Postoperative Peripheral Antagonistic Magnetic Stimulation with 1.5 tesla intensity. Trials were repeated twice a week in sessions of 30 minutes during 6 months
  • Magnetic Stimulation with 1.5 tesla intensity Device
    ARM 1: Kind: Experimental
    Label: Motor function
    Description: Postoperative Peripheral Antagonistic Magnetic Stimulation with 1.5 tesla intensity. Trials were repeated twice a week in sessions of 30 minutes during 6 months
  • - Postoperative Antagonistic Peripheral Magnetic Stimulation Procedure
    Other Names: - Preoperative Peripheral Nerve Blockade; - Selective Peripheral Neurotomy; - Kinesic Rehabilitation Therapy
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Kinesics
    Description: - Classic Rehabilitation and Kinesic Therapy
    ARM 2: Kind: Experimental
    Label: surgery
    Description: - Selective Peripheral Neurotomy is surgical a method of section on suplying of peripheral nerves motor fascicles to relieve harmful spasticity
    ARM 3: Kind: Experimental
    Label: Magnetic Stimulation
    Description: - Postoperative Antagonistic Peripheral Magnetic Stimulation with 1.5 tesla intensity. Trials repeated twice a week in sessions of 30 minutes during 6 months
  • Selected Peripheral Magnetic Stimulation Device
    Intervention Desc: 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)
    ARM 1: Kind: Experimental
    Label: Magnetic Stimulation
    Description: - Postoperative Antagonistic Peripheral Magnetic Stimulation with 1.5 tesla intensity. Trials repeated twice a week in sessions of 30 minutes during 6 months
  • Kinesics Other
    Other Names: Classic Rehabilitation Treatment
    Intervention Desc: Session of classic Kinetic Rehabilitation and motor exercises, twice a week on Physicians´s office and dayly on patient´s home.
    ARM 1: Kind: Experimental
    Label: Kinesics
    Description: - Classic Rehabilitation and Kinesic Therapy
    ARM 2: Kind: Experimental
    Label: surgery
    Description: - Selective Peripheral Neurotomy is surgical a method of section on suplying of peripheral nerves motor fascicles to relieve harmful spasticity
    ARM 3: Kind: Experimental
    Label: Magnetic Stimulation
    Description: - Postoperative Antagonistic Peripheral Magnetic Stimulation with 1.5 tesla intensity. Trials repeated twice a week in sessions of 30 minutes during 6 months
  • Selective Peripheral Magnetic Stimulation Device
    Intervention Desc: 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)
    ARM 1: Kind: Experimental
    Label: Magnetic Stimulation
    Description: - 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

Trial Design

  • Allocation: Non-Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Modified Ashworth Scale (MAS) Post operative Modified Ashworth Scale and Barthel Scale set up monthly for each patient taking into account the postoperative date, during six continued months. No
Secondary Fugl - Meyer Scale Post operative Fugl - Meyer Scale evaluation, setted up monthly for each patient taking into account the postoperative date, during six continued months. No
Secondary Barthel Scale Post operative Barthel Scale evaluation setted up monthly for each patient taking into account the postoperative date, during six continued months. No

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