Added-value of early post-stroke spasticity reduction during arm-hand rehabilitation treatment on improving functional arm-hand skill performance in sub acute stroke patients with a severely or moderately affected arm-hand
- Conditions
- 10007963subacute stroke spasticity
- Registration Number
- NL-OMON43425
- Lead Sponsor
- Adelante
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
- Age ><=18 years;
- supratentorial stroke, i.e. arteria cerebri media infarction;
- sub acute phase after stroke, i.e. between 2 weeks and 3 months post-stroke;
- severe paretic arm and hand: UAT score 1-3;
- eligible to participate in a specific arm-hand rehabilitation program (CARAS) for a period of 12 weeks;
- sufficient cognitive level, i.e. being able to understand the questionnaires and measurement instructions;
- functional disabling spasticity in the upper extremity: Modified Ashworth Scale (MAS) score 1+ to 3 (developing within 5 weeks after the start of CARAS).;As to functional disabling spasticity in the upper extremity, patients developing spasticity in the early subacute phase after stroke (i.e. within 5 weeks after the start of CARAS) with a Modified Ashworth Scale (MAS) score of 1+ to 3 will continue to participate in the study. In contrast, in patients who have a severe paretic arm and hand (UAT score 1-3) at admission to the rehabilitation centre, but who do not develop early signs of spasticity within 5 weeks after start of arm-hand treatment (thereby not being in the target group), measurements will cease.
- severe non-stroke related co-morbidity that may interfere with arm-hand function;
- additional orthopaedic, neurological or rheumatologic impairments of the arms and/or hands and or trunk that may interfere with the execution of the measurements;
- no informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Action Research Arm Test (ARAT), gauging functional capacity.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Fugl-Meyer Motor Assessment (FM), gauging arm-hand function level;<br /><br>- JAMAR strength test, gauging muscle strength;<br /><br>- Motricity Index (MI): Functional strength measurement during performance of<br /><br>daily tasks;<br /><br>- Modified Ashworth Scale (MAS): gauging spasticity levels in the upper<br /><br>extremity;<br /><br>- ABILHAND, gauging perceived level of arm-hand skill/activity proficiency;<br /><br>- Bilateral arm activity monitoring: As to actual arm-hand skill performance,<br /><br>bilateral activity monitors (3D accelerometry, AX3, Axivity Ltd) will be worn<br /><br>around both wrists.</p><br>