Smart Autonomous Neuro-Rehabilitation System

NCT02816008 | Completed

• 1 other identifier: SANaR
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cognition Disorders; Cognitive Deficits

Keywords

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

Outcome Measures

Primary Outcomes (10)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Cognitive rehabilitation group

EXPERIMENTAL

Cognitive rehabilitation training with RGS in the clinic.

Behavioral: Cognitive rehabilitation training with RGS in the clinic

Passive control group

ACTIVE COMPARATOR

Passive/conventional cognitive training at home.

Behavioral: Passive/conventional cognitive training at home.

Interventions

Cognitive rehabilitation training with RGS in the clinic BEHAVIORAL

Daily cognitive training with the Rehabilitation Gaming System (RGS) in the clinic during 6 weeks (5 days per week a 30 minutes).

Cognitive rehabilitation group

Passive/conventional cognitive training at home. BEHAVIORAL

Daily conventional cognitive rehabilitation at home as recommended by the neurologist during 6 weeks (5 days per week a 30 minutes).

Passive control group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat Pompeu Fabra: lead
• Hospital de la Esperanza: collaborator

Related Publications (5)

• 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.

  PMID: 21440699 BACKGROUND

• 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.

  PMID: 12425704 BACKGROUND

• 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.

  PMID: 25741721 BACKGROUND

• 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.

  PMID: 17636703 BACKGROUND

• 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.

  PMID: 32143674 DERIVED

MeSH Terms

Conditions

Cognition Disorders

Interventions

PITX2 protein, human

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Study Officials

• Esther Duarte Oller, MD, PhD

  Parc de Salut Mar - Hospital de l'esperança

  PRINCIPAL INVESTIGATOR

• Paul F.M.J. Verschure, PhD

  Director Specs

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 28, 2016
• Study Start: July 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: May 23, 2018

Record last verified: 2018-05