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Smart Autonomous Neuro-Rehabilitation System (SANaR)

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ClinicalTrials.gov Identifier: NCT02816008
Recruitment Status : Completed
First Posted : June 28, 2016
Last Update Posted : May 23, 2018
Sponsor:
Collaborator:
Hospital de la Esperanza
Information provided by (Responsible Party):
Paul Verschure, Universitat Pompeu Fabra

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.

Condition or disease Intervention/treatment Phase
Cognition Disorders Cognitive Deficits Behavioral: Cognitive rehabilitation training with RGS in the clinic Behavioral: Passive/conventional cognitive training at home. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Cognitive rehabilitation group
Cognitive rehabilitation training with RGS in the clinic.
Behavioral: Cognitive rehabilitation training with RGS in the clinic
Daily cognitive training with the Rehabilitation Gaming System (RGS) in the clinic during 6 weeks (5 days per week a 30 minutes).

Active Comparator: Passive control group
Passive/conventional cognitive training at home.
Behavioral: Passive/conventional cognitive training at home.
Daily conventional cognitive rehabilitation at home as recommended by the neurologist during 6 weeks (5 days per week a 30 minutes).




Primary Outcome Measures :
  1. Change in Digit Span Forward WAIS-IV from baseline to end of treatment and to follow-up [ Time Frame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) ]
    Measurement of attention

  2. Change in Corsi block tapping test from baseline to end of treatment and to follow-up [ Time Frame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) ]
    Measurement of attention

  3. Change in Trail Making Test, Part A from baseline to end of treatment and to follow-up [ Time Frame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) ]
    Measurement of attention

  4. Change in Rey Auditory Verbal Learning Test from baseline to end of treatment and to follow-up [ Time Frame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) ]
    Measurement of episodic memory

  5. Change in Digit Span Backward WAIS-IV from baseline to end of treatment and to follow-up [ Time Frame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) ]
    Measurement of working memory

  6. Change in Corsi block-tapping test reversed from baseline to end of treatment and to follow-up [ Time Frame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) ]
    Measurement of working memory

  7. Change in Frontal Assessment Battery from baseline to end of treatment and to follow-up [ Time Frame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) ]
    Measurement of executive functioning

  8. Change in Trail Making Test, Part B from baseline to end of treatment and to follow-up [ Time Frame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) ]
    Measurement of set-shifting

  9. Change in Digit Symbol Coding in WAIS-IV from baseline to end of treatment and to follow-up [ Time Frame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) ]
    Measurement of processing speed

  10. Change in Star Cancellation test from baseline to end of treatment and to follow-up [ Time Frame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) ]
    Measurement of spatial neglect


Secondary Outcome Measures :
  1. Change in Montreal Cognitive Assessment from baseline to end of treatment and to follow-up [ Time Frame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) ]
    Measurement of global cognitive ability

  2. Change in Mini-Mental State Examination from baseline to end of treatment and to follow-up [ Time Frame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) ]
    Measurement of global health status

  3. Change in Barthel Index from baseline to end of treatment and to follow-up [ Time Frame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) ]
    Measurement of independent functioning and mobility in activities of daily living

  4. Change in Fugl-Meyer Assessment from baseline to end of treatment and to follow-up [ Time Frame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) ]
    Measurement of motor recovery after stroke



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02816008


Sponsors and Collaborators
Universitat Pompeu Fabra
Hospital de la Esperanza
Investigators
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Principal Investigator: Esther Duarte Oller, MD, PhD Parc de Salut Mar - Hospital de l'esperança
Study Director: Paul F.M.J. Verschure, PhD Director Specs
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paul Verschure, PhD, Universitat Pompeu Fabra
ClinicalTrials.gov Identifier: NCT02816008    
Other Study ID Numbers: SANaR
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Paul Verschure, Universitat Pompeu Fabra:
cognitive rehabilitation
memory
attention
spatial neglect
executive dysfunctioning
Additional relevant MeSH terms:
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Cognition Disorders
Cognitive Dysfunction
Neurocognitive Disorders
Mental Disorders