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Postural feedback combined with Non-invasive transcranial direct current stimulation in patients with stroke, a randomized controlled clinical trial.

Postural feedback combined with Non-invasive transcranial direct current stimulation in patients with stroke, a randomized controlled clinical trial. - POTENTIAL RCT

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47155
Enrollment
56
Registered
2015-06-09
Start date
2016-10-13
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Stroke

Interventions

A three week VR-PFT intervention applied five days per week for one hour will be started within five weeks post-stroke, in addition to usual care. This intensive training will be given in order to t

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Berg Balance scale, assessing functional balance performance.

Secondary

MeasureTime frame
(10mwt) 10 meter walk test, (FES) fall efficacy scale, (FM-MS) Fugl-Meyer Motor Score, (MI) motricity index, (EmNSA) Erasmus modification of the Nottingham sensory assessment, (BI) barthel index, (NEADL) Nottingham extended activity of daily living,(O-LCT) O letter cancelation task (SIS) stroke impact scale; assessing function, activity and participation. Postural balance control parameters and spatial-temporal changes in functional cortical networks and connectivity.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)