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Smart Autonomous Neuro-Rehabilitation System

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02816008
Acronym
SANaR
Enrollment
59
Registered
2016-06-28
Start date
2016-07-31
Completion date
2018-02-28
Last updated
2018-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognition Disorders, Cognitive Deficits

Keywords

cognitive rehabilitation, memory, attention, spatial neglect, executive dysfunctioning

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.

Interventions

BEHAVIORALCognitive 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).

BEHAVIORALPassive/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).

Sponsors

Hospital de la Esperanza
CollaboratorUNKNOWN
Universitat Pompeu Fabra
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Star Cancellation test from baseline to end of treatment and to follow-upMeasured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)Measurement of spatial neglect
Change in Corsi block-tapping test reversed from baseline to end of treatment and to follow-upMeasured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)Measurement of working memory
Change in Frontal Assessment Battery from baseline to end of treatment and to follow-upMeasured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)Measurement of executive functioning
Change in Trail Making Test, Part B from baseline to end of treatment and to follow-upMeasured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)Measurement of set-shifting
Change in Digit Symbol Coding in WAIS-IV from baseline to end of treatment and to follow-upMeasured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)Measurement of processing speed
Change in Digit Span Forward WAIS-IV from baseline to end of treatment and to follow-upMeasured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)Measurement of attention
Change in Corsi block tapping test from baseline to end of treatment and to follow-upMeasured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)Measurement of attention
Change in Trail Making Test, Part A from baseline to end of treatment and to follow-upMeasured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)Measurement of attention
Change in Rey Auditory Verbal Learning Test from baseline to end of treatment and to follow-upMeasured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)Measurement of episodic memory
Change in Digit Span Backward WAIS-IV from baseline to end of treatment and to follow-upMeasured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)Measurement of working memory

Secondary

MeasureTime frameDescription
Change in Mini-Mental State Examination from baseline to end of treatment and to follow-upMeasured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)Measurement of global health status
Change in Barthel Index from baseline to end of treatment and to follow-upMeasured 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
Change in Fugl-Meyer Assessment from baseline to end of treatment and to follow-upMeasured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)Measurement of motor recovery after stroke
Change in Montreal Cognitive Assessment from baseline to end of treatment and to follow-upMeasured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)Measurement of global cognitive ability

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026