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

NCT03528018 | Completed

• 3 other identifiers: NISA-PHYS-2016/1TIN2014-61975-EXPBES-2014-068218
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Keywords

Virtual Reality; Rehabilitation; Physical therapy

Outcome Measures

Primary Outcomes (1)

• 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

  The Fugl-Meyer Assessment of Motor Recovery after Stroke evaluates and measures recovery in post-stroke hemiplegic patients in both clinical and research settings. Score range: 0-66

  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 (5)

• 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

  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)

• 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.

  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)

• Change in the Nottingham Sensory Assessment from baseline to the end of the intervention and from the end to one-month after the intervention.

  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)

• Intrinsic Motivation Inventory

  Post-intervention (within 5 days after intervention)

• System Usability Scale

  Post-intervention (within 5 days after intervention)

Study Arms (2)

Control

OTHER

Conventional physical therapy

Other: Physical therapy

Experimental

EXPERIMENTAL

Combined tDCS and VR-based intervention

Device: REACt system; Other: Physical therapy

Interventions

REACt system 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

Experimental

Physical therapy 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

Control; Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospitales Nisa: lead
• Universitat Politècnica de València: collaborator

Study Sites (1)

Servicio de Neurorrehabilitación y Daño Cerebral de los Hospitales NISA

Valencia, 46011, Spain

Location

MeSH Terms

Conditions

Stroke; Paresis; Arm Injuries

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Roberto Llorens, PhD

  Universitat Politècnica de València

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 17, 2018
• Study Start: June 1, 2015
• Primary Completion: July 30, 2016
• Study Completion: September 17, 2016
• Last Updated: May 17, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)