Clinical trial NCT02816008: Smart Autonomous Neuro-Rehabilitation System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognition Disorders
Cognitive Deficits
Keywords: cognitive rehabilitation
memory
attention
spatial neglect
executive dysfunctioning
Lead sponsor: Universitat Pompeu Fabra
Sponsor class: OTHER
Collaborators: name: Hospital de la Esperanza
First posted: 2016-06-28
Enrollment: 59
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Digit Span Forward WAIS-IV from baseline to end of treatment and to follow-up
timeFrame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
measure: Change in Corsi block tapping test from baseline to end of treatment and to follow-up
timeFrame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
measure: Change in Trail Making Test, Part A from baseline to end of treatment and to follow-up
timeFrame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
measure: Change in Rey Auditory Verbal Learning Test from baseline to end of treatment and to follow-up
timeFrame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
measure: Change in Digit Span Backward WAIS-IV from baseline to end of treatment and to follow-up
timeFrame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
measure: Change in Corsi block-tapping test reversed from baseline to end of treatment and to follow-up
timeFrame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
measure: Change in Frontal Assessment Battery from baseline to end of treatment and to follow-up
timeFrame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
measure: Change in Trail Making Test, Part B from baseline to end of treatment and to follow-up
timeFrame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
measure: Change in Digit Symbol Coding in WAIS-IV from baseline to end of treatment and to follow-up
timeFrame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
measure: Change in Star Cancellation test from baseline to end of treatment and to follow-up
timeFrame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Secondary outcomes:
measure: Change in Montreal Cognitive Assessment from baseline to end of treatment and to follow-up
timeFrame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
measure: Change in Mini-Mental State Examination from baseline to end of treatment and to follow-up
timeFrame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
measure: Change in Barthel Index from baseline to end of treatment and to follow-up
timeFrame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
measure: Change in Fugl-Meyer Assessment from baseline to end of treatment and to follow-up
timeFrame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Other outcomes:
Locations:
Study officials:
affiliation: Parc de Salut Mar - Hospital de l'esperança
name: Esther Duarte Oller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Director Specs
name: Paul F.M.J. Verschure, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.
citation: 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.
citation: 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.