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Clinical Trials/NCT02857803
NCT02857803
Completed
Not Applicable

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

Universidade da Madeira1 site in 1 country42 target enrollmentJune 2016
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Universidade da Madeira
Enrollment
42
Locations
1
Primary Endpoint
Change from baseline in the Montreal Cognitive Assessment
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

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).

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
January 10, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sergi Bermúdez i Badia

Professor Auxiliar

Universidade da Madeira

Eligibility Criteria

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

  • Severe depressive symptoms as assessed by the Beck Depression Inventory

Outcomes

Primary Outcomes

Change from baseline in the Montreal Cognitive Assessment

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

Secondary Outcomes

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

Study Sites (1)

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