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Completed

NCT Number: NCT02857803

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Serviço de Saúde da Região Autónoma da Madeira

Funchal, Madeira, 9004-514, Portugal

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality

Procedure

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

Paper and Pencil

Procedure

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

Conventional Therapy

Procedure

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

Primary outcomes

  1. Change from baseline in the Montreal Cognitive Assessment

    Time frame: Baseline, End (4-6 weeks) and 8-weeks follow-up

Secondary outcomes

  1. Change from baseline in the Trail Making Test A and B

    Time frame: Baseline, End (4-6 weeks) and 8-weeks follow-up

  2. Change from baseline in the Verbal Paired Associates (WMS III)

    Time frame: Baseline, End (4-6 weeks) and 8-weeks follow-up

  3. Change from baseline in the Digit Span (WAIS III)

    Time frame: Baseline, End (4-6 weeks) and 8-weeks follow-up

  4. Change from baseline in the Symbol Search and Coding (WAIS III)

    Time frame: Baseline, End (4-6 weeks) and 8-weeks follow-up

Other outcomes

  1. Crystallised Intelligence as assesed by Comprehension from the WAIS III

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Universidade da Madeira

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 5, 2016
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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