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

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ClinicalTrials.gov Identifier: NCT03528018
Recruitment Status : Completed
First Posted : May 17, 2018
Last Update Posted : May 17, 2018
Sponsor:
Collaborator:
Universitat Politècnica de València
Information provided by (Responsible Party):
Hospitales Nisa

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

Condition or disease Intervention/treatment Phase
Stroke Hemiparesis Chronic Stroke Upper Limb Injury Device: REACt system Other: Physical therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : July 30, 2016
Actual Study Completion Date : September 17, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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

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




Primary Outcome Measures :
  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 [ Time Frame: 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) ]
    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


Secondary Outcome Measures :
  1. 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 [ Time Frame: 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) ]
    The Wolf Motor Function Test is a quantitative measure of upper extremity motor ability through timed and functional tasks. Score range: 0-1200

  2. 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. [ Time Frame: 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) ]
    The Wolf Motor Function Test is a quantitative measure of upper extremity motor ability through timed and functional tasks. Score range: 0-75

  3. Change in the Nottingham Sensory Assessment from baseline to the end of the intervention and from the end to one-month after the intervention. [ Time Frame: 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) ]
    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)

  4. Intrinsic Motivation Inventory [ Time Frame: Post-intervention (within 5 days after intervention) ]
    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

  5. System Usability Scale [ Time Frame: Post-intervention (within 5 days after intervention) ]
    The System Usability Scale is a simple ten-item scale that serves as a global assessment of subjective usability. Score range: 0-100



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528018


Locations
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Spain
Servicio de Neurorrehabilitación y Daño Cerebral de los Hospitales NISA
Valencia, Spain, 46011
Sponsors and Collaborators
Hospitales Nisa
Universitat Politècnica de València
Investigators
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Principal Investigator: Roberto Llorens, PhD Universitat Politècnica de València
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Responsible Party: Hospitales Nisa
ClinicalTrials.gov Identifier: NCT03528018    
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 )
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospitales Nisa:
Virtual Reality
Rehabilitation
Physical therapy
Additional relevant MeSH terms:
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Stroke
Paresis
Arm Injuries
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Wounds and Injuries