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Positioning and electrical stimulation in stroke.

Positioning and electrical stimulation in stroke. - PAESIS-trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32161
Enrollment
36
Registered
2008-12-08
Start date
2008-09-10
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebrovascular accident (CVA) stroke

Interventions

In addition to the care as usual, subjects allocated to the experimental group will undergo 8 weeks of shoulder/arm positioning combined with therapeutic electrical stimulation of the extensor muscl

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
1. Passive range of motion of the shoulder, elbow, forearm and wrist using a masked fluid-filled goniometer. 2. Shoulder pain using a Dutch translation of the AbilityQ/ShoulderQ. This is a questionnaire.

Secondary

MeasureTime frame
1. Impact of arm spasticity on arm activities in daily life using the Leeds Arm Spasticity Impact Scale (LASIS). This is a questionnaire. 2. Spasticity/hypertonia of the shoulder internal rotators, elbow flexors and extensors and the long finger flexors using the Modified Tardieu Scale. 3. The amount of use of spasticity and pain medication. 4. Selective movement ability of the hemiplegic arm using the 66-point arm section of the Fugl-Meyer Assessment. 5. The degree of shoulder subluxation using a simple clinical scale.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)