Smart Autonomous Neuro-Rehabilitation System

Cognition Disorders Clinical Trial

— SANaR  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816008
• Other study ID #: SANaR
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: February 2018

Study information

• Verified date: May 2018
• Source: Universitat Pompeu Fabra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Deficits
• Cognitive Dysfunction

Intervention

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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universitat Pompeu Fabra	Hospital de la Esperanza

References & Publications (4)

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. — View Citation

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. Review. — View Citation

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. — View Citation

Nair RD, Lincoln NB. Cognitive rehabilitation for memory deficits following stroke. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD002293. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Digit Span Forward WAIS-IV from baseline to end of treatment and to follow-up	Measurement of attention	Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Primary	Change in Corsi block tapping test from baseline to end of treatment and to follow-up	Measurement of attention	Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Primary	Change in Trail Making Test, Part A from baseline to end of treatment and to follow-up	Measurement of attention	Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Primary	Change in Rey Auditory Verbal Learning Test from baseline to end of treatment and to follow-up	Measurement of episodic memory	Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Primary	Change in Digit Span Backward WAIS-IV from baseline to end of treatment and to follow-up	Measurement of working memory	Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Primary	Change in Corsi block-tapping test reversed from baseline to end of treatment and to follow-up	Measurement of working memory	Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Primary	Change in Frontal Assessment Battery from baseline to end of treatment and to follow-up	Measurement of executive functioning	Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Primary	Change in Trail Making Test, Part B from baseline to end of treatment and to follow-up	Measurement of set-shifting	Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Primary	Change in Digit Symbol Coding in WAIS-IV from baseline to end of treatment and to follow-up	Measurement of processing speed	Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Primary	Change in Star Cancellation test from baseline to end of treatment and to follow-up	Measurement of spatial neglect	Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Secondary	Change in Montreal Cognitive Assessment from baseline to end of treatment and to follow-up	Measurement of global cognitive ability	Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Secondary	Change in Mini-Mental State Examination from baseline to end of treatment and to follow-up	Measurement of global health status	Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Secondary	Change in Barthel Index from baseline to end of treatment and to 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)
Secondary	Change in Fugl-Meyer Assessment from baseline to end of treatment and to follow-up	Measurement of motor recovery after stroke	Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)