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

October 11, 2019 updated by: Sergi Bermúdez i Badia, Universidade da Madeira

The Impact of Using an Interactive System, a Paper and Pencil Program or Conventional Methodologies in the Rehabilitation of Stroke Patients: a Randomised Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
    • Madeira
      • Funchal, Madeira, Portugal, 9004-514
        • Serviço de Saúde da Região Autónoma da Madeira

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Virtual Reality
Intervention of 30 minutes, 3 times a week until reaching 12 sessions.
Active Comparator: 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.
Procedure: Paper and Pencil
Intervention of 30 minutes, 3 times a week until reaching 12 sessions.
Active Comparator: Conventional Therapy
The Conventional Therapy group will perform the activities offered by the public health system, which are motor-focused.
Procedure: Conventional Therapy
Intervention of 30 minutes, 3 times a week until reaching 12 sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the Montreal Cognitive Assessment
Time Frame: Baseline, End (4-6 weeks) and 8-weeks follow-up
Baseline, End (4-6 weeks) and 8-weeks follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the Trail Making Test A and B
Time Frame: Baseline, End (4-6 weeks) and 8-weeks follow-up
Baseline, End (4-6 weeks) and 8-weeks follow-up
Change from baseline in the Verbal Paired Associates (WMS III)
Time Frame: Baseline, End (4-6 weeks) and 8-weeks follow-up
Baseline, End (4-6 weeks) and 8-weeks follow-up
Change from baseline in the Digit Span (WAIS III)
Time Frame: Baseline, End (4-6 weeks) and 8-weeks follow-up
Baseline, End (4-6 weeks) and 8-weeks follow-up
Change from baseline in the Symbol Search and Coding (WAIS III)
Time Frame: Baseline, End (4-6 weeks) and 8-weeks follow-up
Baseline, End (4-6 weeks) and 8-weeks follow-up

Other Outcome Measures

Outcome Measure
Time Frame
Crystallised Intelligence as assesed by Comprehension from the WAIS III
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade da Madeira

Collaborators

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

Investigators

  • Principal Investigator: Sergi Bermudez i Badia, PhD, Universidade da Madeira

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

January 8, 2019

Study Completion (Actual)

January 10, 2019

Study Registration Dates

First Submitted

August 3, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 5, 2016

Study Record Updates

Last Update Posted (Actual)

October 15, 2019

Last Update Submitted That Met QC Criteria

October 11, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 303891

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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