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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02857803
Enrollment
42
Registered
2016-08-05
Start date
2016-06-30
Completion date
2019-01-10
Last updated
2019-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Virtual Reality, Cognitive Rehabilitation, Motor Rehabilitation, Ecological validity, Personalisation

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).

Interventions

PROCEDUREVirtual Reality

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

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

PROCEDUREConventional Therapy

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

Sponsors

Serviço de Saúde da Região Autónoma da Madeira (SESARAM), E.P.E.
CollaboratorUNKNOWN
Universidade da Madeira
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change from baseline in the Montreal Cognitive AssessmentBaseline, End (4-6 weeks) and 8-weeks follow-up

Secondary

MeasureTime frame
Change from baseline in the Trail Making Test A and BBaseline, 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

Other

MeasureTime frame
Crystallised Intelligence as assesed by Comprehension from the WAIS IIIBaseline

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026