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Smart Autonomous Neuro-Rehabilitation System (SANaR)

Primary Purpose

Cognition Disorders, Cognitive Deficits

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive rehabilitation training with RGS in the clinic
Passive/conventional cognitive training at home.
Sponsored by
Universitat Pompeu Fabra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognition Disorders focused on measuring cognitive rehabilitation, memory, attention, spatial neglect, executive dysfunctioning

Eligibility Criteria

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

Inclusion Criteria:

  • Score on Mini-Mental State Examination between 18 - 24
  • Score on Montreal Cognitive Assessment less than 26
  • More than 2 points in upper limb motor scale MRC
  • Sufficient cognitive ability to understand and follow the experimental instructions

Exclusion Criteria:

  • Score on Mini-Mental State Examination below 18 or above 24
  • Score on Montreal Cognitive Assessment of 26 or above
  • Below 2 point in upper limb motor scale MRC
  • Hemianopia
  • Cognitive capacity that prohibits the execution of the experiment
  • Severe impairment like spasticity, aphasia or apraxia, major pain or other neuromuscular impairments or dependent on use of orthopedic devices that would interfere with the correct execution of understanding of the experiment
  • History of serious mental-health problems in acute or subacute phase
  • Patients that do not give their consent to participate in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Cognitive rehabilitation group

    Passive control group

    Arm Description

    Cognitive rehabilitation training with RGS in the clinic.

    Passive/conventional cognitive training at home.

    Outcomes

    Primary Outcome Measures

    Change in Digit Span Forward WAIS-IV from baseline to end of treatment and to follow-up
    Measurement of attention
    Change in Corsi block tapping test from baseline to end of treatment and to follow-up
    Measurement of attention
    Change in Trail Making Test, Part A from baseline to end of treatment and to follow-up
    Measurement of attention
    Change in Rey Auditory Verbal Learning Test from baseline to end of treatment and to follow-up
    Measurement of episodic memory
    Change in Digit Span Backward WAIS-IV from baseline to end of treatment and to follow-up
    Measurement of working memory
    Change in Corsi block-tapping test reversed from baseline to end of treatment and to follow-up
    Measurement of working memory
    Change in Frontal Assessment Battery from baseline to end of treatment and to follow-up
    Measurement of executive functioning
    Change in Trail Making Test, Part B from baseline to end of treatment and to follow-up
    Measurement of set-shifting
    Change in Digit Symbol Coding in WAIS-IV from baseline to end of treatment and to follow-up
    Measurement of processing speed
    Change in Star Cancellation test from baseline to end of treatment and to follow-up
    Measurement of spatial neglect

    Secondary Outcome Measures

    Change in Montreal Cognitive Assessment from baseline to end of treatment and to follow-up
    Measurement of global cognitive ability
    Change in Mini-Mental State Examination from baseline to end of treatment and to follow-up
    Measurement of global health status
    Change in Barthel Index from baseline to end of treatment and to follow-up
    Measurement of independent functioning and mobility in activities of daily living
    Change in Fugl-Meyer Assessment from baseline to end of treatment and to follow-up
    Measurement of motor recovery after stroke

    Full Information

    First Posted
    June 21, 2016
    Last Updated
    May 22, 2018
    Sponsor
    Universitat Pompeu Fabra
    Collaborators
    Hospital de la Esperanza
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02816008
    Brief Title
    Smart Autonomous Neuro-Rehabilitation System
    Acronym
    SANaR
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2016 (undefined)
    Primary Completion Date
    February 2018 (Actual)
    Study Completion Date
    February 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitat Pompeu Fabra
    Collaborators
    Hospital de la Esperanza

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Cognitive rehabilitation is defined as a systematic functionally oriented intervention of therapeutic cognitive activities based on the assessment and understanding of patient's brain behavior deficits. This project focuses on restoring cognitive functions in order to understand the underlying deficits in the patient's brain by developing integrated cognitive rehabilitation scenarios in virtual reality that combine memory, attention and problem solving training with context specific motor movements.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cognition Disorders, Cognitive Deficits
    Keywords
    cognitive rehabilitation, memory, attention, spatial neglect, executive dysfunctioning

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Cognitive rehabilitation group
    Arm Type
    Experimental
    Arm Description
    Cognitive rehabilitation training with RGS in the clinic.
    Arm Title
    Passive control group
    Arm Type
    Active Comparator
    Arm Description
    Passive/conventional cognitive training at home.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive rehabilitation training with RGS in the clinic
    Intervention Description
    Daily cognitive training with the Rehabilitation Gaming System (RGS) in the clinic during 6 weeks (5 days per week a 30 minutes).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Passive/conventional cognitive training at home.
    Intervention Description
    Daily conventional cognitive rehabilitation at home as recommended by the neurologist during 6 weeks (5 days per week a 30 minutes).
    Primary Outcome Measure Information:
    Title
    Change in Digit Span Forward WAIS-IV from baseline to end of treatment and to follow-up
    Description
    Measurement of attention
    Time Frame
    Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
    Title
    Change in Corsi block tapping test from baseline to end of treatment and to follow-up
    Description
    Measurement of attention
    Time Frame
    Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
    Title
    Change in Trail Making Test, Part A from baseline to end of treatment and to follow-up
    Description
    Measurement of attention
    Time Frame
    Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
    Title
    Change in Rey Auditory Verbal Learning Test from baseline to end of treatment and to follow-up
    Description
    Measurement of episodic memory
    Time Frame
    Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
    Title
    Change in Digit Span Backward WAIS-IV from baseline to end of treatment and to follow-up
    Description
    Measurement of working memory
    Time Frame
    Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
    Title
    Change in Corsi block-tapping test reversed from baseline to end of treatment and to follow-up
    Description
    Measurement of working memory
    Time Frame
    Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
    Title
    Change in Frontal Assessment Battery from baseline to end of treatment and to follow-up
    Description
    Measurement of executive functioning
    Time Frame
    Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
    Title
    Change in Trail Making Test, Part B from baseline to end of treatment and to follow-up
    Description
    Measurement of set-shifting
    Time Frame
    Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
    Title
    Change in Digit Symbol Coding in WAIS-IV from baseline to end of treatment and to follow-up
    Description
    Measurement of processing speed
    Time Frame
    Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
    Title
    Change in Star Cancellation test from baseline to end of treatment and to follow-up
    Description
    Measurement of spatial neglect
    Time Frame
    Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
    Secondary Outcome Measure Information:
    Title
    Change in Montreal Cognitive Assessment from baseline to end of treatment and to follow-up
    Description
    Measurement of global cognitive ability
    Time Frame
    Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
    Title
    Change in Mini-Mental State Examination from baseline to end of treatment and to follow-up
    Description
    Measurement of global health status
    Time Frame
    Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
    Title
    Change in Barthel Index from baseline to end of treatment and to follow-up
    Description
    Measurement of independent functioning and mobility in activities of daily living
    Time Frame
    Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
    Title
    Change in Fugl-Meyer Assessment from baseline to end of treatment and to follow-up
    Description
    Measurement of motor recovery after stroke
    Time Frame
    Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Score on Mini-Mental State Examination between 18 - 24 Score on Montreal Cognitive Assessment less than 26 More than 2 points in upper limb motor scale MRC Sufficient cognitive ability to understand and follow the experimental instructions Exclusion Criteria: Score on Mini-Mental State Examination below 18 or above 24 Score on Montreal Cognitive Assessment of 26 or above Below 2 point in upper limb motor scale MRC Hemianopia Cognitive capacity that prohibits the execution of the experiment Severe impairment like spasticity, aphasia or apraxia, major pain or other neuromuscular impairments or dependent on use of orthopedic devices that would interfere with the correct execution of understanding of the experiment History of serious mental-health problems in acute or subacute phase Patients that do not give their consent to participate in the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Esther Duarte Oller, MD, PhD
    Organizational Affiliation
    Parc de Salut Mar - Hospital de l'esperança
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Paul F.M.J. Verschure, PhD
    Organizational Affiliation
    Director Specs
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    21440699
    Citation
    Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley JP, Bergquist T, Azulay J, Cantor J, Ashman T. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil. 2011 Apr;92(4):519-30. doi: 10.1016/j.apmr.2010.11.015.
    Results Reference
    background
    PubMed Identifier
    12425704
    Citation
    Ball K, Berch DB, Helmers KF, Jobe JB, Leveck MD, Marsiske M, Morris JN, Rebok GW, Smith DM, Tennstedt SL, Unverzagt FW, Willis SL; Advanced Cognitive Training for Independent and Vital Elderly Study Group. Effects of cognitive training interventions with older adults: a randomized controlled trial. JAMA. 2002 Nov 13;288(18):2271-81. doi: 10.1001/jama.288.18.2271.
    Results Reference
    background
    PubMed Identifier
    25741721
    Citation
    Corbetta M, Ramsey L, Callejas A, Baldassarre A, Hacker CD, Siegel JS, Astafiev SV, Rengachary J, Zinn K, Lang CE, Connor LT, Fucetola R, Strube M, Carter AR, Shulman GL. Common behavioral clusters and subcortical anatomy in stroke. Neuron. 2015 Mar 4;85(5):927-41. doi: 10.1016/j.neuron.2015.02.027.
    Results Reference
    background
    PubMed Identifier
    17636703
    Citation
    Nair RD, Lincoln NB. Cognitive rehabilitation for memory deficits following stroke. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD002293. doi: 10.1002/14651858.CD002293.pub2.
    Results Reference
    background
    PubMed Identifier
    32143674
    Citation
    Maier M, Ballester BR, Leiva Banuelos N, Duarte Oller E, Verschure PFMJ. Adaptive conjunctive cognitive training (ACCT) in virtual reality for chronic stroke patients: a randomized controlled pilot trial. J Neuroeng Rehabil. 2020 Mar 6;17(1):42. doi: 10.1186/s12984-020-0652-3.
    Results Reference
    derived

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