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

Not Applicable

Completed

• Conditions: Chronic Stroke; Hemiparesis; Upper Limb Injury; Stroke
• Interventions: Other: Physical therapy; Device: REACt system

• Registration Number: NCT03528018
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-01
• Primary Completion: 2016-07-30
• Study Completion: 2016-09-17
• Study First Submitted: 2018-04-24
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-16
• Last Update Submitted: 2018-05-16
• Study First Posted: 2018-05-17
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Physical therapy	Conventional physical therapy
Experimental	REACt system	Combined tDCS and VR-based intervention
Experimental	Physical therapy	Combined tDCS and VR-based intervention

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
Intrinsic Motivation Inventory	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
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)	The Wolf Motor Function Test is a quantitative measure of upper extremity motor ability through timed and functional tasks. Score range: 0-1200
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)	The Wolf Motor Function Test is a quantitative measure of upper extremity motor ability through timed and functional tasks. Score range: 0-75
System Usability Scale	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
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)	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)

Trial Locations

Locations (1)

Servicio de Neurorrehabilitación y Daño Cerebral de los Hospitales NISA; 🇪🇸 Valencia, Spain