search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Improving standing balance after stroke with tDCS and postural feedback therapy.


- candidate number22374
- NTR NumberNTR5261
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-jun-2015
- Secondary IDsNL52021.029.15 
- Public TitleImproving standing balance after stroke with tDCS and postural feedback therapy.
- Scientific Title‘POTENTIAL: Postural feedback combined with Non-invasive Transcranial direct current stimulation in patients with stroke, a randomized controlled clinical trial.’
- ACRONYMPOTENTIAL RCT
- hypothesisVR-based postural feedback training combined with non-invasive cerebellar tDCS is more effective as compared to the same balance training program with sham-stimulation in improving postural balance control parameters and standing balance performance in sub-acute stroke patients
- Healt Condition(s) or Problem(s) studiedtDCS, Stroke, Balance
- Inclusion criteria1) A postural balance deficit as determined by a Berg Balance Scale score of 47 or lower, 2) a first ever ischemic lesion in the territory of the middle cerebral artery (MCA) as verified by CT of MRI scan, 3) age ≥ 30, 4) written informed consent, 5) be able to stand for 30 seconds without support 6) normal vision or corrected to normal with an optical aid, 7) able and sufficiently motivated to perform the required tests and intervention sessions.
- Exclusion criteria1) Any Presence of metallic implants (pacemaker etc.) , pacemaker, intracranial electrodes, implanted defibrillators, cranial pathologies (e.g. holes, plaques) or any other prosthesis, 2) orthopaedic limitations that interfere with the study, 3) not being able to communicate , 3) successful thrombolysis treatment ( no clinical sequel of the stroke) , 4) No neurological disease or condition (except from the stroke) 5) Cranial bone defects, 6) history of epileptic seizures, 7) diagnoses bipolar or psychiatric disorder 8) signs of depression (Hospital Anxiety and Depression Scale, HADS, sub score D≥10) (Zigmond and Snaith 1983) 9) insufficient cognitive function (Mini Mental State Examination, MMSE < 19), 10) sensory impairments prior to the ischemic lesion (patients will be asked if they have a medical history of neuropathy), 11) diagnosed diseases of the vestibular system, 12) not able to lie flat for 30 min or claustrophobia (MRI scan).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingTriple
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 24-sep-2016
- planned closingdate1-sep-2018
- Target number of participants46
- InterventionsA tree week VR-PFT intervention applied five days per week for one hour will be started within three weeks post-stroke, in addition to usual care. This intensive training will be given in order to test if VR-PFT in combination with cerebellar tDCS is more effective in improving standing balance than VR-PFT alone. Patients train in groups and go along workstations consisting of a virtual reality setup in which instantaneous visual feedback is given regarding centre of gravity or trunk movements during several balance tasks. These tasks requiring active control of body posture and equilibrium in a virtual environment. The training program is individually tailored and progressive with systematic increments in task difficulty. tDCS will be simultaneously applied with the training during the first 25 minutes of each session using a pre-programmed stimulation paradigm. Sham-tDCS starts with a ramped stimulation of 30s followed by 0 mA current without the subject knowing this.
- Primary outcomeBerg Balance scale, assessing functional balance performance.
- Secondary outcomePosturography and mean power frequency and amplitude in relevant frequency bands
- Timepoints3 months
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMsc. Sarah Zandvliet
- CONTACT for SCIENTIFIC QUERIES Erwin van Wegen
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Hersenstichting Nederland
- Publications
- Brief summaryPostural instability, balance problems and subsequent falls are very common in patients with a stroke and strongly associated with future functional recovery. The early period after stroke is characterized by a critical time window of neuroplasticity. Postural feedback training (PFT) is a common rehabilitative therapy to improve standing balance control in patients with stroke, and is equally effective to improve balance control as usual care. Studies suggest that a positive, reproducible effect on motor learning may be achieved by simultaneous non-invasive transcranial direct current stimulation (tDCS) and motor training. A combination of early applied tDCS and PFT by modern virtual reality techniques (VR-PFT) may therefore improve balance in patients with stroke to a level unattained by VR-PFT alone. To date, non-invasive brain stimulation has not been applied in combination with modern balance training techniques in stroke.
- Main changes (audit trail)27-aug-2017: Wijzigingen in inclusie, exclusie en interventie -MT:

INCLUSION CRITERIA:
1) A postural balance deficit as determined by a Berg Balance Scale score of 47 or lower, 2) a first ever ischemic lesion in the territory of the middle cerebral artery (MCA) as verified by CT of MRI scan, 3) age ≥ 30, 4) written informed consent, 5) be able to stand for 30 seconds without support 6) normal vision or corrected to normal with an optical aid, 7) able and sufficiently motivated to perform the required tests and intervention sessions.

Replaced by

1) A postural balance deficit as determined by a Berg Balance Scale score of 50 or lower, 2) less than five weeks after a first ever cortical or subcortical ischemic lesion, excluding lesions of the cerebellum, 3) age ≥ 30, 4) written informed consent, 5) be able to stand for 30 seconds with minimal support 6) normal vision or corrected to normal with an optical aid, 7) able and sufficiently motivated to perform the required tests and intervention sessions.

EXCLUSION CRITERIA: number 12 is removed because of expire of the MRI

INTERVENTIONS:
A tree week VR-PFT intervention applied five days per week for one hour will be started within three weeks post-stroke, in addition to usual care. This intensive training will be given in order to test if VR-PFT in combination with cerebellar tDCS is more effective in improving standing balance than VR-PFT alone. Patients train in groups and go along workstations consisting of a virtual reality setup in which instantaneous visual feedback is given regarding centre of gravity or trunk movements during several balance tasks. These tasks requiring active control of body posture and equilibrium in a virtual environment. The training program is individually tailored and progressive with systematic increments in task difficulty. tDCS will be simultaneously applied with the training during the first 25 minutes of each session using a pre-programmed stimulation paradigm. Sham-tDCS starts with a ramped stimulation of 30s followed by 0 mA current without the subject knowing this.

Replaced by:

A tree 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 test if VR-PFT in combination with cerebellar tDCS is more effective in improving standing balance than VR-PFT alone. Patients train in groups and go along workstations consisting of a virtual reality setup in which instantaneous visual feedback is given regarding centre of gravity or trunk movements during several balance tasks. These tasks requiring active control of body posture and equilibrium in a virtual environment. The training program is individually tailored and progressive with systematic increments in task difficulty. tDCS will be simultaneously applied with the training during the first 25 minutes of each session using a pre-programmed stimulation paradigm. Sham-tDCS starts with a ramped stimulation of 30s followed by 0 mA current without the subject knowing this.
- RECORD22-jun-2015 - 27-aug-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl