Efficacy of a Combined Transcranial Direct Current Stimulation and Virtual Reality Intervention

NCT ID: NCT03528018

Last Updated: 2018-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2016-09-17

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

Conditions

Stroke; Hemiparesis; Chronic Stroke; Upper Limb Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control

Conventional physical therapy

Group Type: OTHER

Physical therapy

Intervention Type: OTHER

Physical therapy included passive and active mobilization of the paretic upper limb. Passive range of motion exercises were provided in those segments where no active movement was detected to meticulously reproduce a range of articular movements and muscle and soft tissue elongation. In case of residual active movement capability, participants were encouraged to perform the movements with the assistance of the therapists

Experimental

Combined tDCS and VR-based intervention

Group Type: EXPERIMENTAL

REACt system

Intervention Type: DEVICE

The REACt system is a virtual reality-based paradigm for upper limb rehabilitation that allows for interaction of individuals with restricted movements from active responses triggered when they attempt to perform a movement. The experimental system also provides multisensory stimulation in the visual, auditory, and tactile channels, and transcranial direct current stimulation coherent to the observed movements

Physical therapy

Intervention Type: OTHER

Physical therapy included passive and active mobilization of the paretic upper limb. Passive range of motion exercises were provided in those segments where no active movement was detected to meticulously reproduce a range of articular movements and muscle and soft tissue elongation. In case of residual active movement capability, participants were encouraged to perform the movements with the assistance of the therapists

Interventions

REACt system

The REACt system is a virtual reality-based paradigm for upper limb rehabilitation that allows for interaction of individuals with restricted movements from active responses triggered when they attempt to perform a movement. The experimental system also provides multisensory stimulation in the visual, auditory, and tactile channels, and transcranial direct current stimulation coherent to the observed movements

Intervention Type: DEVICE

Physical therapy

Physical therapy included passive and active mobilization of the paretic upper limb. Passive range of motion exercises were provided in those segments where no active movement was detected to meticulously reproduce a range of articular movements and muscle and soft tissue elongation. In case of residual active movement capability, participants were encouraged to perform the movements with the assistance of the therapists

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitat Politècnica de València

OTHER

Sponsor Role: collaborator

Hospitales Nisa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roberto Llorens, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitat Politècnica de València

Locations

Servicio de Neurorrehabilitación y Daño Cerebral de los Hospitales NISA

Valencia, , Spain

Countries

Spain

Other Identifiers

TIN2014-61975-EXP

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

BES-2014-068218

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NISA-PHYS-2016/1

Identifier Type: -

Identifier Source: org_study_id