Combined Antagonistic Muscle Magnetic Stimulation and Selective Periferal Neurotomy to Improve Results on Spasticity
- Conditions
- STROKE
- Interventions
- Procedure: - Postoperative Antagonistic Peripheral Magnetic StimulationOther: KinesicsDevice: Selective Peripheral Magnetic Stimulation
- Registration Number
- NCT02226432
- Lead Sponsor
- Juan Carlos M. Andreani MD
- Brief Summary
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 15
- 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
- Severe cardiovascular disease
- Severe pulmonary disease
- Neoplasia advanced disease
- Joint anchylosis
- Irreversible retraction for muscle fibrosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Kinesics Kinesics - Classic Rehabilitation and Kinesic Therapy surgery - Postoperative Antagonistic Peripheral Magnetic Stimulation - 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 Kinesics - 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 Kinesics - Postoperative Antagonistic Peripheral Magnetic Stimulation - Classic Rehabilitation and Kinesic Therapy surgery Kinesics - 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 - Postoperative Antagonistic Peripheral Magnetic Stimulation - 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 Magnetic Stimulation Selective Peripheral Magnetic Stimulation - 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
- Primary Outcome Measures
Name Time Method Modified Ashworth Scale (MAS) Post operative Modified Ashworth Scale /MAS) setted up monthly for each patient taking into account the postoperative date, during six continued months. - Mean Preoperative and sequencial monthly postoperative evaluation of stiffness and ranges of joint pasive movements at the shoulder, elbow, wrist and fingers.
- Secondary Outcome Measures
Name Time Method 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. Pre and post operative evaluation of a set of active and pasive movements and articular angles in the upper limb
Barthel Scale Post operative Barthel Scale evaluation setted up monthly for each patient taking into account the postoperative date, during six continued months. 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