Domiciliary VR Rehabilitation

NCT ID: NCT02699398

Last Updated: 2016-03-04

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

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-07-31

Brief Summary

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The purpose of this study is to determine whether domiciliary VR-based telerehabilitation is superior than domiciliary occupational therapy for inducing functional gains, enhancing corticospinal excitability, and cortical reorganization.

Detailed Description

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Conditions

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Hemiparesis Functional Independence Movement Disorder Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VR-based therapy

3 weeks of home-based treatment for motor training using a virtual reality rehabilitation setup.

Group Type EXPERIMENTAL

Domiciliary VR-based motor rehabilitation

Intervention Type BEHAVIORAL

3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system.

Control

3 weeks of home-based occupational therapy for motor training.

Group Type ACTIVE_COMPARATOR

Domiciliary occupational therapy for motor rehabilitation

Intervention Type BEHAVIORAL

3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system.

Interventions

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Domiciliary VR-based motor rehabilitation

3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system.

Intervention Type BEHAVIORAL

Domiciliary occupational therapy for motor rehabilitation

3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of Hemorrhagic or ischemic stroke
* Subject had the stroke more than 12 months ago.
* Subject presents mild-to-moderate upper-limbs hemiparesis (Proximal Medial Research Council Scale\>2) secondary to a first-ever stroke.
* Age between 45 and 85 years old.
* Subject has previous experience using the RGS system in the clinic.

Exclusion Criteria

* Subject presents a major cognitive impairment (Mini-Mental State Evaluation\> 22).
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital del Mar

OTHER

Sponsor Role collaborator

Hospital Vall d'Hebron

OTHER

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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Paul Verschure, PhD

Role: PRINCIPAL_INVESTIGATOR

Synthetic Perceptive, Emotive and Cognitive Systems group, Department of Information and Communication Technologies at the Universitat Pompeu Fabra (UPF).

References

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Ballester BR, Nirme J, Camacho I, Duarte E, Rodriguez S, Cuxart A, Duff A, Verschure PFMJ. Domiciliary VR-Based Therapy for Functional Recovery and Cortical Reorganization: Randomized Controlled Trial in Participants at the Chronic Stage Post Stroke. JMIR Serious Games. 2017 Aug 7;5(3):e15. doi: 10.2196/games.6773.

Reference Type DERIVED
PMID: 28784593 (View on PubMed)

Other Identifiers

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AAL-2008-1-1191

Identifier Type: -

Identifier Source: org_study_id

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