|- candidate number||5564|
|- NTR Number||NTR1748|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-apr-2009|
|- Secondary IDs||2008.107 / ABR no. 22402.042.08 Medical Ethical Committee University Medical Center Groningen / CCMO|
|- Public Title||Preventieve armpositionering en elektrostimulatie bij CVA-patiŽnten.|
|- Scientific Title||Positioning And Electrical Stimulation In Stroke.|
|- Healt Condition(s) or Problem(s) studied||Stroke|
|- 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||1. Any of the following contra indications for electrical stimulation:|
A. Metal implants in the involved arm or shoulder;
B. Cardiac pacemaker;
E. Cancerous lesions;
F. Skin infections on forearm or shoulder blade;
G. Epileptic seizures six months previous to and since the stroke;
H. 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 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).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||11-aug-2008|
|- planned closingdate||31-dec-2010|
|- Target number of participants||38|
|- Interventions||The experimental group receives a standardised therapeutic procedure for the hemiplegic arm and simultaneous therapeutic electrical stimulation (TES) with a motor response (i.e. joint movement is elicited) of the external rotators of the shoulder and extensors of the forearm twice a day for 45 minutes on working days. |
The control group receives a (sham) positioning procedure at half the available shoulder range of motion and simultaneous conventional transcutaneous electrical nerve stimulation (TENS) with a sensory response only (i.e. no movement is elicited) of the extensors of the forearm twice a day for 45 minutes on working days.
|- Primary outcome||1. Passive range of motion (PROM) of seven different arm movements will be assessed using a using a masked hydrogoniometer;|
2. Shoulder pain will be assessed using the ShoulderQ.
|- Secondary outcome||1. The degree of difficulty the patient and his/her primary carer have with activities related to the hemiplegic (spastic) arm is assessed with the Leeds Arm Spasticity Impact Scale (LASIS);|
2. Arm spasticity will be assessed using the Modified Tardieu Scale (MTS);
3. The 66-point arm section of the Fugl-Meyer Assessment (FMA) will be used to assess the ability to make selective movements of the hemiplegic arm;
4. The degree of shoulder inferior subluxation is clinically graded in (half) fingerbreadths palpable below the acromion process in both shoulders.
|- Timepoints||Measurements will be made at baseline, after 4 weeks (intermediate), after 8 weeks (outcome) and after 20 weeks (follow-up).|
|- Trial web site||www.vogellanden.nl|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MSc PT Lex D. Jong, de|
|- CONTACT for SCIENTIFIC QUERIES||MSc PT Lex D. Jong, de|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Department of Rehabilitation Medicine|
(Source(s) of Monetary or Material Support)
|- Brief summary||Each year more than 41.000 people are struck by a stroke in the Netherlands. In more than 60% of the cases the hemiplegic arm remains without function. Disuse of the arm makes it prone to the occurrence of contracture formation and spasticity. This results in hemiplegic shoulder pain, motor impairments and activity limitations (e.g. cleaning the arm, dressing). Available evidence based single-modality treatments are not suitable for patients with poor motor performance, and severely affected patients are underrepresented in the research literature. Positioning procedures and electrical stimulation both seem best suitable for severely affected stroke patients and combining these treatment modalities may even be more efficacious. We hypothesize that the electrical stimulation intensifies the effect of the positioning procedure, resulting in slowing down of contracture formation, less hemiplegic shoulder pain, less restrictions in the stroke patientís performance of activities of daily life, decreased levels of spasticity and prevention of subluxation.|
|- Main changes (audit trail)|
|- RECORD||7-apr-2009 - 17-jun-2010|