Smart Autonomous Neuro-Rehabilitation System

Not Applicable

Completed

• Conditions: Cognitive Deficits; Cognition Disorders
• Interventions: Behavioral: Cognitive rehabilitation training with RGS in the clinic; Behavioral: Passive/conventional cognitive training at home.

• Registration Number: NCT02816008
• Lead Sponsor: Universitat Pompeu Fabra

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-28
• Study Start: 2016-07
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-22
• Last Update Posted: 2018-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive rehabilitation group	Cognitive rehabilitation training with RGS in the clinic	Cognitive rehabilitation training with RGS in the clinic.
Passive control group	Passive/conventional cognitive training at home.	Passive/conventional cognitive training at home.

Primary Outcome Measures

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

Secondary Outcome Measures

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