Efficacy of a Combined Transcranial Direct Current Stimulation and Virtual Reality Intervention (REACT01)

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

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

Study Overview

• Status: Completed
• Conditions: Stroke; Hemiparesis; Chronic Stroke; Upper Limb Injury
• Intervention / Treatment: Other: Physical therapy; Device: REACt system

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46011
    • Servicio de Neurorrehabilitación y Daño Cerebral de los Hospitales NISA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control; Conventional physical therapy	Other: 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
Experimental: Experimental; Combined tDCS and VR-based intervention	Other: 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; Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The Wolf Motor Function Test is a quantitative measure of upper extremity motor ability through timed and functional tasks. Score range: 0-1200	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.	The Wolf Motor Function Test is a quantitative measure of upper extremity motor ability through timed and functional tasks. Score range: 0-75	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.	The Nottingham Sensory Assessment is a multi-modal sensory examination that includes tests of tactile sensation (Score range: 0-2) (light, touch, touch localization, temperature discrimination, pinprick sensation, bilateral simultaneous stimulation), kinesthesia (Score range:0-3), and stereognosis (Score range: 0-2)	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	The Intrinsic Motivation Inventory is a multidimensional questionnaire structured into various subscales. In this study, this questionnaire was used to assess participant interest/enjoyment, perceived competence, pressure/tension, and value/usefulness measures. Score range for each subscale: 1-7	Post-intervention (within 5 days after intervention)
System Usability Scale	The System Usability Scale is a simple ten-item scale that serves as a global assessment of subjective usability. Score range: 0-100	Post-intervention (within 5 days after intervention)

Collaborators and Investigators

• Sponsor: Hospitales Nisa
• Collaborators: Universitat Politècnica de València
• Investigators: Principal Investigator: Roberto Llorens, PhD, Universitat Politécnica de Valéncia

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): July 30, 2016
• Study Completion (Actual): September 17, 2016

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (Actual): May 17, 2018

Study Record Updates

• Last Update Posted (Actual): May 17, 2018
• Last Update Submitted That Met QC Criteria: May 16, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Rehabilitation; Virtual Reality; Physical therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Stroke; Paresis; Arm Injuries
• Other Study ID Numbers: NISA-PHYS-2016/1; TIN2014-61975-EXP (Other Grant/Funding Number: Ministerio de Economía y Competitividad of Spain); BES-2014-068218 (Other Grant/Funding Number: Ministerio de Economía y Competitividad of Spain)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No