A Randomised Controlled Trial Comparing the Impact of Virtual Reality, Paper and Pencil and Conventional Methods on Stroke Rehabilitation

NCT ID: NCT02857803

Last Updated: 2019-10-15

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-01-10

Brief Summary

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Virtual Reality allows the integration of both cognitive and motor rehabilitation in a more ecologically valid context. The purpose of this study is to determine whether this methodology has more impact on stroke rehabilitation than a paper and pencil personalised program and conventional therapy, which is motor-focused.

Detailed Description

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Cognitive impairments after stroke are not always given sufficient attention despite its limitations in activities-of-daily- living (ADL's). Current cognitive rehabilitation methods mostly rely on paper-and-pencil tasks targeting isolated domains, which is not consistent with everyday-life. Besides limited ecological-validity, paper-and-pencil tasks are not accessible for most stroke patients whose dominant arm is paretic. Virtual Reality (VR) has shown to be a solution for the development of accessible and ecologically valid systems, but, does it have more impact than a paper and pencil personalised intervention?

Through a participatory design approach, with health professionals, the investigators have developed:

* a motor-accessible and cognitive-personalized VR-based system, where conventional cognitive tasks were operationalized in meaningful simulations of ADL's (Reh@City) and;
* a web tool which generates personalised paper and pencil tasks( Task Generator).

The investigators objective is to have a sample of 60 stroke patients between 40 and 70 years old, randomly allocated in three groups: the experimental group 1 were participants will perform 30 minutes of the VR training with Reh@City; the experimental group 2 were participants will perform 30 minutes of the paper and pencil training with the Task Generator, and the control group were participants will perform 30 minutes of conventional therapy (occupational therapy).

Conditions

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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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Virtual Reality

The Virtual Reality group will perform personalised activities of daily living in the context of a simulated city (Reh@City). The interaction with the virtual environment will be through a natural user interface.

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type PROCEDURE

Intervention of 30 minutes, 3 times a week until reaching 12 sessions.

Paper and Pencil

The paper and pencil group will perform a set of cognitive paper and pencil tasks personalised to their deficits and generated automatically through a Task Generator.

Group Type ACTIVE_COMPARATOR

Paper and Pencil

Intervention Type PROCEDURE

Intervention of 30 minutes, 3 times a week until reaching 12 sessions.

Conventional Therapy

The Conventional Therapy group will perform the activities offered by the public health system, which are motor-focused.

Group Type ACTIVE_COMPARATOR

Conventional Therapy

Intervention Type PROCEDURE

Intervention of 30 minutes, 3 times a week until reaching 12 sessions.

Interventions

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Virtual Reality

Intervention of 30 minutes, 3 times a week until reaching 12 sessions.

Intervention Type PROCEDURE

Paper and Pencil

Intervention of 30 minutes, 3 times a week until reaching 12 sessions.

Intervention Type PROCEDURE

Conventional Therapy

Intervention of 30 minutes, 3 times a week until reaching 12 sessions.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ischemic stroke with more than 6 months post-stroke
* cognitive deficit but with enough capacity to understand the task and follow instructions with a minimum score of 11 over 17 in the Token Test (6-item version, Portuguese population)
* able to read and write

Exclusion Criteria

* Neglect
* Severe depressive symptoms as assessed by the Beck Depression Inventory
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Serviço de Saúde da Região Autónoma da Madeira (SESARAM), E.P.E.

UNKNOWN

Sponsor Role collaborator

Universidade da Madeira

OTHER

Sponsor Role lead

Responsible Party

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Sergi Bermúdez i Badia

Professor Auxiliar

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sergi Bermudez i Badia, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade da Madeira

Locations

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Serviço de Saúde da Região Autónoma da Madeira

Funchal, Madeira, Portugal

Site Status

Countries

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Portugal

References

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Faria, A. L., & Bermúdez i Badia, S. (2015). Development and evaluation of a web-based cognitive task generator for personalized cognitive training: a proof of concept study with stroke patients. In REHAB 2015: 3rd Workshop on ICTs for improving Patients Research Techniques. ACM.

Reference Type BACKGROUND

Faria, A. L., Vourvopoulos, A., Cameirão, M. S., Fernandes, J. C., & Bermúdez i Badia, S. (2014). An integrative virtual reality cognitive-motor intervention approach in stroke rehabilitation: a pilot study. In 10th ICDVRAT, Gothenburg, Sweden, Sept. 2-4, 2014.

Reference Type BACKGROUND

Vourvopoulos, A., Faria, A. L., Ponnam, K., & Bermúdez i Badia, S. (2014). RehabCity: Design and Validation of a Cognitive Assessment and Rehabilitation Tool through Gamified Simulations of Activities of Daily Living. In 11th International Conference on Advances in Computer Entertainment Technology. Funchal, Portugal.

Reference Type BACKGROUND

Faria AL, Pinho MS, Bermudez I Badia S. A comparison of two personalization and adaptive cognitive rehabilitation approaches: a randomized controlled trial with chronic stroke patients. J Neuroeng Rehabil. 2020 Jun 16;17(1):78. doi: 10.1186/s12984-020-00691-5.

Reference Type DERIVED
PMID: 32546251 (View on PubMed)

Related Links

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Other Identifiers

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303891

Identifier Type: -

Identifier Source: org_study_id

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