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

ConditionSTROKE
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25+
SponsorJuan Carlos M. Andreani MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Severe cardiovascular disease

Severe pulmonary disease

Neoplasia advanced disease

Joint anchylosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • - Postoperative Antagonistic Peripheral Magnetic Stimulation

    Procedure/Surgery

    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

  • 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 intervention

    Session of classic Kinetic Rehabilitation and motor exercises, twice a week on Physicians´s office and dayly on patient´s home.

Treatment groups

15 Participants
are divided into 3 treatment groups
Group A: KinesicsSham comparator 2 interventions
Group B: surgerySham comparator 2 interventions
Group C: Magnetic StimulationActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Post operative Modified Ashworth Scale /MAS) setted up monthly for each patient taking into account the postoperative date, during six continued months.

Secondary outcomes

1

Fugl - Meyer Scale

Pre and post operative evaluation of a set of active and pasive movements and articular angles in the upper limb

Time frame
Post operative Fugl - Meyer Scale evaluation, setted up monthly for each patient taking into account the postoperative date, during six continued months.
2

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

Time frame
Post operative Barthel Scale evaluation setted up monthly for each patient taking into account the postoperative date, during six continued months.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Juan Carlos M. Andreani MD

Lead sponsor

Sociedad Argenttina de Neuromodulación

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: