Smart Autonomous Neuro-Rehabilitation System

NCT ID: NCT02816008

Last Updated: 2018-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-02-28

Brief Summary

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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

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Conditions

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Cognition Disorders Cognitive Deficits

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive rehabilitation group

Cognitive rehabilitation training with RGS in the clinic.

Group Type EXPERIMENTAL

Cognitive rehabilitation training with RGS in the clinic

Intervention Type BEHAVIORAL

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

Passive control group

Passive/conventional cognitive training at home.

Group Type ACTIVE_COMPARATOR

Passive/conventional cognitive training at home.

Intervention Type BEHAVIORAL

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

Interventions

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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).

Intervention Type BEHAVIORAL

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de la Esperanza

UNKNOWN

Sponsor Role collaborator

Universitat Pompeu Fabra

OTHER

Sponsor Role lead

Responsible Party

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Paul Verschure

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Esther Duarte Oller, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Parc de Salut Mar - Hospital de l'esperança

Paul F.M.J. Verschure, PhD

Role: STUDY_DIRECTOR

Director Specs

References

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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.

Reference Type BACKGROUND
PMID: 21440699 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12425704 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25741721 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17636703 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32143674 (View on PubMed)

Other Identifiers

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SANaR

Identifier Type: -

Identifier Source: org_study_id

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