Smart Autonomous Neuro-Rehabilitation System (SANaR)

May 22, 2018 updated by: Paul Verschure, Universitat Pompeu Fabra
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
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
Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
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
Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
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
Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
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
Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
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
Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
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
Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
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
Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
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
Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
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
Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
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
Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
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
Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
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
Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitat Pompeu Fabra

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital de la Esperanza

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SANaR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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