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Counteracting Learned Non-use Through Augmented Visuomotor Feedback in Virtual Reality (RGS)

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ClinicalTrials.gov Identifier: NCT02657070
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : January 15, 2016
Sponsor:
Collaborator:
Hospital Universitari Joan XXIII de Tarragona.
Information provided by (Responsible Party):
Paul Verschure, Universitat Pompeu Fabra

Study Description
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Brief Summary:
The purpose of this study is to determine if Reinforcement-Induced Movement Therapy (RIMT), a novel rehabilitation method that augments visuomotor feedback of movements of the patient in virtual reality, is effective in treating hemiparesis resp. learned non-use.

Condition or disease Intervention/treatment Phase
Hemiparesis Behavioral: Reinforcement-Induced Movement Therapy (RIMT) Behavioral: VR-based motor rehabilitation in RGS without augmented feedback Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Desaprendiendo la parálisis Aprendida Con RGS en Pacientes Afectos de Ictus
Study Start Date : March 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Group
Virtual reality based therapy with augmented visuomotor feedback.
 Behavioral: Reinforcement-Induced Movement Therapy (RIMT)
6 weeks, 1 session a day, 30min per sessions, of physical therapy using a VR rehabilitation gaming system (RGS) with augmented visuomotor feedback
Other Name: VR-based motor rehabilitation in RGS with amplified visuomotor feedback
Active Comparator: Control Group
Virtual reality based therapy without augmentation.
 Behavioral: VR-based motor rehabilitation in RGS without augmented feedback
6 weeks, 1 session a day, 30min per sessions, of physical therapy using a VR rehabilitation gaming system (RGS)


Outcome Measures
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Primary Outcome Measures :
  1. The upper extremity Fugl-Meyer Assessment [ Time Frame: at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up ]
    change from baseline in motor function


Secondary Outcome Measures :
  1. Chedoke Arm Hand Inventory [ Time Frame: at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up ]
    change from baseline in functional recovery

  2. Barthel Index [ Time Frame: at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up ]
    change from baseline in activities of daily living

  3. Hamilton Scale [ Time Frame: at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up ]
    change from baseline in measurement of depression


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild-to-moderate upper-limbs hemiparesis (Proximal Medical Research Council Scale > 2) due to ischemic or hemorrhagic stroke
  • Spasticity in the affected limb (Modified Ashworth Scale <3)
  • First-ever ischemic or hemorrhagic stroke (>4 weeks post-stroke)
  • Sufficient cognitive capacity for following the instruction of the intervention (Mini-Mental State Evaluation >24)

Exclusion Criteria:

  • Cognitive impairment that impede the correct execution or understanding of the intervention
  • Severe impairments in vision or visual perception abilities (such as vision loss or spatial neglect), in spasticity, in communication abilities (such as aphasia or apraxia), severe pain as well as other neuromuscular or orthopedic changes that impede the correct execution of the intervention training
  • Mental dysfunctioning during the acute or subacute phase after the stroke.
Contacts and Locations
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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): NCT02657070


Sponsors and Collaborators
Universitat Pompeu Fabra
Hospital Universitari Joan XXIII de Tarragona.
Investigators
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Principal Investigator: Rosa Maria San Segundo Mozo, Dra. Medico Especialista en Medician Fisica y Rehabilitation, Doctora por al Universitat Rovira i Virgili de Tarragona
Study Director: Paul F.M.J. Verschure, Prof. Director SPECS
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Paul Verschure, Prof., Universitat Pompeu Fabra
ClinicalTrials.gov Identifier: NCT02657070    
Other Study ID Numbers: CEIC 53/2013
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016
Keywords provided by Paul Verschure, Universitat Pompeu Fabra:
Stroke
learned non-use
Virtual Reality
Hemiparesis
Additional relevant MeSH terms:
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Paresis
Neurologic Manifestations
Nervous System Diseases