Trial document
DRKS00007899
Trial Description
Title
The effects of repetitive peripheral magnetic stimulation in patient with spastic hemiparesis after stroke: A randomized-controlled study
Trial Acronym
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URL of the Trial
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Brief Summary in Lay Language
In this study, the effectiveness of repetitive peripheral magnet stimulation (rPMS) is compared to peripheral electrical stimulation.
rPMS improves the functional status of a paretic hand/arm and spasticity after stroke. Since now it is unclear how effective rPMS is.
Patients were randomly assigned to “magnetic stimulation group” or “electrical stimulation group.
The stimulation is applied every day from monday to friday for 3 weeks. In regular intervals assessments were performed for the function of the upper limb and mobility to find out how effective rPMS is.
We hypothesized that rPMS is the more effective stimulation method to improve lost functions in the affected upper limb and the activities of daily living.
Brief Summary in Scientific Language
Repetitive peripheral magnetic stimulation (rPMS) is a stimulation method with strong and rapidly changed magnetic fields that's applicated on a muscle to produce repetitive muscle contractions.
The first rPMS trials by patients after stroke were performed in the 90s by the research group by Albrecht Struppler. These first trials indicated an improvement of voluntary activity, spasticity and perception after rPMS.
In this randomized-controlled trial the effect of rPMS will be examined in patients after stroke. The patients are randomly assigned in the intervention group(magnetic stimulation) and the control group (electrical stimulation). The intervention /controllintervention be applied daily (mon-fri) over three weeks.
To investigate the short- and long-term effects standardized the assessments will be evaluated at different times.
Organizational Data
- DRKS00007899
- 2015/03/24
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- yes
- Approved
- 4147-07/14, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
Secondary IDs
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Health Condition or Problem studied
- I60-I69 - Cerebrovascular diseases
- G81.1 - Spastic hemiplegia
Interventions/Observational Groups
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repetitive peripheral magnetic stimulation (rPMS) (interventiongroup):
The stimulation is 15 minutes daily for three weeks with a total of 15 sessions.
The stimulation intensity is adjusted individually for each patient, so that a joint movement resulting from the muscle contraction.
Muscles of the upper arm and forearm are stimulated with a butterfly coil;
The patient takes a sitting position with raised feet in the wheelchair or on a chair with backrest;
The arm is placed to be stimulated or maintained by the therapist
magnetic stimulator: Magstim Rapid²
Instruction:
Patients are asked to relax and observe their arm -
peripheral electrical stimulation (controlgroup):
The stimulation is 15 minutes daily for three weeks with a total of 15 sessions.
The stimulation intensity is adjusted individually for each patient, so that a joint movement resulting from the muscle contraction.
Muscles of the upper arm and forearm are stimulated with electrodes;
The patient takes a sitting position with raised feet in the wheelchair or on a chair with backrest;
The arm is placed to be stimulated or maintained by the therapist;
Electrical device: wellcare digi stim
Instruction: Patients are asked to relax and observe their arm
Characteristics
- Interventional
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- Randomized controlled trial
- Blinded
- assessor
- Active control (effective treament of control group)
- Treatment
- Parallel
- N/A
- N/A
Primary Outcome
The primary outcome is the Fugl-Meyer Test of the upper extremity, a test that evaluated the function of the affected upper extremity. This test will be performed directly after the end of the three weeks intervention-/controllintervention.
Secondary Outcome
The secondary outcome is determined with a questionnaire, the Katz Index of Independence Activities of daily living (ADL). That questionnaire aims to identify the dependence in the performance in the activities of daily living and will be performed six months after the end of the intervention /controllintervention.
Countries of Recruitment
- Germany
Locations of Recruitment
- Medical Center
Recruitment
- Actual
- 2015/04/15
- 80
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- no minimum age
- no maximum age
Additional Inclusion Criteria
subacute stroke (incident not longer than six months back)
spastic hemiparesis of the upper limb (at least modified ashworth scale 1)
a slight function in the fingers or hand (at least 1 point in the Fugl-Meyer-test in subscore C)
Exclusion Criteria
Epilepsy,
implantated metal in the stimulation area
implantated medical devices
dysfunctional speech comprehension
pregnancy
Addresses
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start of 1:1-Block address primary-sponsor
- Moritz Klinik Bad Klosterlausnitz
- Hermann-Sachse-Straße 46
- 07639 Bad Klosterlausnitz
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- [---]*
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end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Moritz Klinik Bad Klosterlausnitz
- Ms. Kristin Pohl
- Hermann-Sachse-Straße 46
- 07639 Bad Klosterlausnitz
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 036601/49418
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- kristin.pohl at moritz-klinik.de
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end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Moritz Klinik Bad Klosterlausnitz
- Ms. Kristin Pohl
- Hermann-Sachse-Straße 46
- 07639 Bad Klosterlausnitz
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 036601/49418
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- kristin.pohl at moritz-klinik.de
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end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Moritz Klinik GmbH & Co.KG
- Hermann-Sachse-Straße 46
- 07639 Bad Klosterlausnitz
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
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- neuro at moritz-klinik.de
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end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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