Clinical trial NCT03528018: Efficacy of a Combined Transcranial Direct Current Stimulation and Virtual Reality Intervention
Official title: Efficacy of a Combined Transcranial Direct Current Stimulation and Virtual Reality-based Paradigm for Upper Limb Rehabilitation in Individuals With Severe Hemiparesia. A Randomized Control Trial Survivor With Severe Hemiparesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiparesis
Chronic Stroke
Upper Limb Injury
Keywords: Virtual Reality
Rehabilitation
Physical therapy
Lead sponsor: Hospitales Nisa
Sponsor class: OTHER
Collaborators: name: Universitat Politècnica de València
First posted: 2018-05-17
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rehabilitation options for stroke survivors who present severe hemiparesis in chronic stages are limited and may end in compensation techniques that involve the use of the less affected arm to achieve some degree of functional independence. Transcranial direct current stimulation (tDCS) is a non-invasive technique that has been used after stroke to promote excitability of the surviving neural architecture in order to support functional recovery. Interestingly, cortical excitability has been reported to increase when tDCS is combined with virtual reality. This synergetic effect could explain the promising results achieved by preliminary experimental interventions that combined both approaches on upper limb rehabilitation after stroke. The objective of this study is to explore the use of these interventions in subjects with severe hemiparesis and to determine its efficacy in comparison to conventional physical therapy


Eligibility criteria: Inclusion Criteria:

* chronicity \> six months
* severe paresis of the upper limb defined by the Brunnstrom Approach as stages I or II and by the Upper Extremity subscale of the Fugl-Meyer Assessment as scores below 19
* ability to maintain a sitting position for at least 60 minutes
* fairly good cognitive condition defined by scores in the Mini-Mental State Examination above 23.

Exclusion Criteria:

* pacemakers
* brain implants or other metallic objects (valves, coils, etc.)
* impaired comprehension that hinder sufficient understanding of the instructions defined by Mississippi Aphasia Screening Test scores below 45
* severe visual impairments
* emotional or behavioral circumstances that impede adequate collaboration

Primary outcomes:
measure: Change in the Upper Extremity subscale of the Fugl-Meyer Assessment Scale from baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
timeFrame: Pre-intervention (within 5 days prior intervention), post-intervention (within 5 days after intervention), one-month follow-up (within 30 to 35 days after the intervention)
Secondary outcomes:
measure: Change in the Time subscale of the Wolf Motor Function Test from baseline to the end of the intervention and from the end to one-month after the intervention
timeFrame: Pre-intervention (within 5 days prior intervention), post-intervention (within 5 days after intervention), one-month follow-up (within 30 to 35 days after the intervention)
measure: Change in the Functional ability subscale of the Wolf Motor Function Test from baseline to the end of the intervention and from the end to one-month after the intervention.
timeFrame: Pre-intervention (within 5 days prior intervention), post-intervention (within 5 days after intervention), one-month follow-up (within 30 to 35 days after the intervention)
measure: Change in the Nottingham Sensory Assessment from baseline to the end of the intervention and from the end to one-month after the intervention.
timeFrame: Pre-intervention (within 5 days prior intervention), post-intervention (within 5 days after intervention), one-month follow-up (within 30 to 35 days after the intervention)
measure: Intrinsic Motivation Inventory
timeFrame: Post-intervention (within 5 days after intervention)
measure: System Usability Scale
timeFrame: Post-intervention (within 5 days after intervention)
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Servicio de Neurorrehabilitación y Daño Cerebral de los Hospitales NISA
Study officials:
affiliation: Universitat Politècnica de València
name: Roberto Llorens, PhD
role: PRINCIPAL_INVESTIGATOR
References: