- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02816008
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
Completed
Conditions
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.
Sponsor
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.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
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
Additional Relevant MeSH Terms
Other Study ID 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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