Positioning and electrical stimulation in stroke.
- Conditions
- strokecerebrovascular accident (CVA)1001076110007963
- Registration Number
- NL-OMON32161
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
1. A first ever or recurrent stroke except subarachnoid hemorrhages,
2. Age above 18,
3. Between 2 and 8 weeks post-stroke,
4. An apparent paralysis / severe paresis of the involved upper limb.
1. Any of the following contra indications for electrical stimulation: metal implants in the involved arm or shoulder, cardiac pacemaker, thrombosis, (thrombo)phlebitis, cancerous lesions, skin infections on forearm or shoulder blade, epileptic seizures six months previous to and/or since the stroke, pregnancy and myasthenia gravis/myotonia,
2. Pre-existent impairments of the affected arm (e.g. peripheral neuropathy, frozen shoulder),
3. The ability to make selective movements of the hemiplegic arm (more than 18 points on the shoulder-and elbow sections of the Fugl-Meyer Assessment arm score),
4. Severe cognitive deficits and/or severe language comprehension difficulties (more than one of four questions wrong on the verbal items of the AbilityQ),
5. Severe neglect (a difference of more than three on the letter cancellation test),
6. Severe loss of pain sensation. This criterium is tested by administering electrical stimulation to the extensor muscles of the forearm arm of the subject. If a patient shows a good motor response during stimulation, but does not feel the stimulation, he/she is excluded if (any) skin irritation occurs after a test-session of 10 minutes using the parameters of the experimental procedure. Patients with severe loss of pain sensation who tolerate the test session well will, for extra safety purposes, receive checks after each electrical stimulation session during participation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Passive range of motion of the shoulder, elbow, forearm and wrist using a<br /><br>masked fluid-filled goniometer.<br /><br>2. Shoulder pain using a Dutch translation of the AbilityQ/ShoulderQ. This is a<br /><br>questionnaire.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Impact of arm spasticity on arm activities in daily life using the Leeds Arm<br /><br>Spasticity Impact Scale (LASIS). This is a questionnaire.<br /><br>2. Spasticity/hypertonia of the shoulder internal rotators, elbow flexors and<br /><br>extensors and the long finger flexors using the Modified Tardieu Scale.<br /><br>3. The amount of use of spasticity and pain medication.<br /><br>4. Selective movement ability of the hemiplegic arm using the 66-point arm<br /><br>section of the Fugl-Meyer Assessment.<br /><br>5. The degree of shoulder subluxation using a simple clinical scale.</p><br>