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

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • 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

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
Intervention / Treatment
Experimental: Cognitive rehabilitation group
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.
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

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

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.

Collaborators

Investigators

  • 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.

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

July 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimate)

June 28, 2016

Study Record Updates

Last Update Posted (Actual)

May 23, 2018

Last Update Submitted That Met QC Criteria

May 22, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

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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