Postural feedback combined with Non-invasive transcranial direct current stimulation in patients with stroke, a randomized controlled clinical trial.
Phase 2
Completed
- Conditions
- Stroke10007963
- Registration Number
- NL-OMON47155
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
1) A postural balance deficit as determined by a Berg Balance Scale score of 50 or lower
2) a first ever ischemic lesion in the territory of the middle cerebral artery (MCA) as verified by CT of MRI scan
Exclusion Criteria
1) Any metallic implants (pacemaker etc.)
2) Orthopedic limitations that interfere with the study
3) Cranial bone defects
4) History of epileptic seizures
5) Signs of depression (Hospital Anxiety and Depression Scale, HADS, sub score D >10)
6) Insufficient cognitive function (Mini Mental State Examination, MMSE < 19)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Berg Balance scale, assessing functional balance performance.</p><br>
- Secondary Outcome Measures
Name Time Method <p> (10mwt) 10 meter walk test, (FES) fall efficacy scale, (FM-MS) Fugl-Meyer<br /><br>Motor Score, (MI) motricity index, (EmNSA) Erasmus modification of the<br /><br>Nottingham sensory assessment, (BI) barthel index, (NEADL) Nottingham extended<br /><br>activity of daily living,(O-LCT) O letter cancelation task (SIS) stroke impact<br /><br>scale; assessing function, activity and participation.<br /><br>Postural balance control parameters and spatial-temporal changes in functional<br /><br>cortical networks and connectivity.</p><br>