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Completed

NCT Number: NCT02816008

Smart Autonomous Neuro-Rehabilitation System

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.

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Key information

Conditions

Cognition Disorders Cognitive Deficits Mental Disorders Neurocognitive Disorders

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive rehabilitation training with RGS in the clinic

Behavioral

Daily cognitive training with the Rehabilitation Gaming System (RGS) in the clinic during 6 weeks (5 days per week a 30 minutes).

Passive/conventional cognitive training at home.

Behavioral

Daily conventional cognitive rehabilitation at home as recommended by the neurologist during 6 weeks (5 days per week a 30 minutes).

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universitat Pompeu Fabra

Other

Collaborators

  • Hospital de la Esperanza

Registry information

Acronym: SANaR

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 28, 2016
Registry last updated
May 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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