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

Not Applicable

Completed

• Conditions: Stroke

• Registration Number: NCT02857803
• Lead Sponsor: Universidade da Madeira

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).

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-08-03
• Study First Submitted QC: 2016-08-03
• Study First Posted: 2016-08-05
• Primary Completion: 2019-01-08
• Study Completion: 2019-01-10
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-11
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in the Montreal Cognitive Assessment	Baseline, End (4-6 weeks) and 8-weeks follow-up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Serviço de Saúde da Região Autónoma da Madeira; 🇵🇹 Funchal, Madeira, Portugal