search
Back to results

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

Primary Purpose

Hemiparesis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Reinforcement-Induced Movement Therapy (RIMT)
VR-based motor rehabilitation in RGS without augmented feedback
Sponsored by
Universitat Pompeu Fabra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiparesis focused on measuring Stroke, learned non-use, Virtual Reality, Hemiparesis

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental Group

    Control Group

    Arm Description

    Virtual reality based therapy with augmented visuomotor feedback.

    Virtual reality based therapy without augmentation.

    Outcomes

    Primary Outcome Measures

    The upper extremity Fugl-Meyer Assessment
    change from baseline in motor function

    Secondary Outcome Measures

    Chedoke Arm Hand Inventory
    change from baseline in functional recovery
    Barthel Index
    change from baseline in activities of daily living
    Hamilton Scale
    change from baseline in measurement of depression

    Full Information

    First Posted
    January 13, 2016
    Last Updated
    January 14, 2016
    Sponsor
    Universitat Pompeu Fabra
    Collaborators
    Hospital Universitari Joan XXIII de Tarragona.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02657070
    Brief Title
    Counteracting Learned Non-use Through Augmented Visuomotor Feedback in Virtual Reality (RGS)
    Official Title
    Desaprendiendo la parálisis Aprendida Con RGS en Pacientes Afectos de Ictus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2014 (undefined)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitat Pompeu Fabra
    Collaborators
    Hospital Universitari Joan XXIII de Tarragona.

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemiparesis
    Keywords
    Stroke, learned non-use, Virtual Reality, Hemiparesis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    23 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group
    Arm Type
    Experimental
    Arm Description
    Virtual reality based therapy with augmented visuomotor feedback.
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    Virtual reality based therapy without augmentation.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Reinforcement-Induced Movement Therapy (RIMT)
    Other Intervention Name(s)
    VR-based motor rehabilitation in RGS with amplified visuomotor feedback
    Intervention Description
    6 weeks, 1 session a day, 30min per sessions, of physical therapy using a VR rehabilitation gaming system (RGS) with augmented visuomotor feedback
    Intervention Type
    Behavioral
    Intervention Name(s)
    VR-based motor rehabilitation in RGS without augmented feedback
    Intervention Description
    6 weeks, 1 session a day, 30min per sessions, of physical therapy using a VR rehabilitation gaming system (RGS)
    Primary Outcome Measure Information:
    Title
    The upper extremity Fugl-Meyer Assessment
    Description
    change from baseline in motor function
    Time Frame
    at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up
    Secondary Outcome Measure Information:
    Title
    Chedoke Arm Hand Inventory
    Description
    change from baseline in functional recovery
    Time Frame
    at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up
    Title
    Barthel Index
    Description
    change from baseline in activities of daily living
    Time Frame
    at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up
    Title
    Hamilton Scale
    Description
    change from baseline in measurement of depression
    Time Frame
    at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rosa Maria San Segundo Mozo, Dra.
    Organizational Affiliation
    Medico Especialista en Medician Fisica y Rehabilitation, Doctora por al Universitat Rovira i Virgili de Tarragona
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Paul F.M.J. Verschure, Prof.
    Organizational Affiliation
    Director SPECS
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    10714655
    Citation
    Ramachandran VS, Rogers-Ramachandran D. Phantom limbs and neural plasticity. Arch Neurol. 2000 Mar;57(3):317-20. doi: 10.1001/archneur.57.3.317.
    Results Reference
    background
    PubMed Identifier
    7886714
    Citation
    de Haan RJ, Limburg M, Van der Meulen JH, Jacobs HM, Aaronson NK. Quality of life after stroke. Impact of stroke type and lesion location. Stroke. 1995 Mar;26(3):402-8. doi: 10.1161/01.str.26.3.402.
    Results Reference
    background
    PubMed Identifier
    16480566
    Citation
    Thomas SA, Lincoln NB. Factors relating to depression after stroke. Br J Clin Psychol. 2006 Mar;45(Pt 1):49-61. doi: 10.1348/014466505X34183.
    Results Reference
    background
    PubMed Identifier
    26684921
    Citation
    Robinson RG, Jorge RE. Post-Stroke Depression: A Review. Am J Psychiatry. 2016 Mar 1;173(3):221-31. doi: 10.1176/appi.ajp.2015.15030363. Epub 2015 Dec 18.
    Results Reference
    background
    PubMed Identifier
    27506203
    Citation
    Ballester BR, Maier M, San Segundo Mozo RM, Castaneda V, Duff A, M J Verschure PF. Counteracting learned non-use in chronic stroke patients with reinforcement-induced movement therapy. J Neuroeng Rehabil. 2016 Aug 9;13(1):74. doi: 10.1186/s12984-016-0178-x.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs