No registrations found.
ID
Source
Brief title
Health condition
Stroke (CVA)
Sponsors and support
University Medical Center Groningen
Department of Rehabilitation Medicine
Postbus 30001
9700 RB Groningen
Telephone: 050-3612295
E-mail: k.postema@rev.umcg.nl
Intervention
Outcome measures
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.
Background 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 patient’s performance of activities of daily life, decreased levels of spasticity and prevention of subluxation.
Study objective
N/A
Study design
Measurements will be made at baseline, after 4 weeks (intermediate), after 8 weeks (outcome) and after 20 weeks (follow-up).
Intervention
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.
Lex D. Jong, de
Rehabilitation Center De Vogellanden
Department of Physical Therapy
Zwolle 8001 BB
The Netherlands
+31 (0)38 4981338
l.de.jong@vogellanden.nl
Lex D. Jong, de
Rehabilitation Center De Vogellanden
Department of Physical Therapy
Zwolle 8001 BB
The Netherlands
+31 (0)38 4981338
l.de.jong@vogellanden.nl
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;
C. Thrombosis;
D. (Thrombo)phlebitis;
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).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL1650 |
| NTR-old | NTR1748 |
| Other | Medical Ethical Committee University Medical Center Groningen / CCMO : 2008.107 / ABR no. 22402.042.08 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |