The effects of repetitive peripheral magnetic stimulation on motor function and spasticity in patients with hemiparesis
Phase 4
- Conditions
- I64S06.9Stroke, not specified as haemorrhage or infarctionIntracranial injury, unspecified
- Registration Number
- DRKS00000798
- Lead Sponsor
- Schön Klinik Bad Aibling
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
• hemiparesis after stroke or traumatic brain injury
• grade 1 to 3 on Tardieu scale
Exclusion Criteria
• co-morbidity with other degenerative diseases
• implanted medical devices, i.e.
o cardiac pacemaker
o Cochlea- implant
• pregnancy
• metal implants (head and/or stimulation area)
• instabile fractures within stimulation area
• pathological intracraniel pressure
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome parameter is the function and spasticity of the paretic upper extremity. The Fugl-Mayer assessment is used to assess function, and the Tardieu scale to assess spasticity. <br>Both scales will be assessed before therapy, at the end of the 2-week treatment period, and 2 weeks after study treatment. Additionally the Tardieu Scale will be assessed after the first and before the third therapy session to determine any short-term effects.
- Secondary Outcome Measures
Name Time Method As secondary outcome the independance in activities of daily living, depression, and the tolerance to the stimulation will be documented. These aspects will assessed by means of the Barthel Index, the 7-item Hamilton Depression Scale, and a self-report questionnaire. Muscle activity of the paretic upper extremity will be measured with electromyography (EMG). All Parameters will be collected before and after the Intervention period, and 2 weeks after study treatment. <br>