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

Stroke Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02857803
• Other study ID #: 303891
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: January 10, 2019

Study information

• Verified date: October 2019
• Source: Universidade da Madeira
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 10, 2019
• Est. primary completion date: January 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• Virtual Reality
Intervention of 30 minutes, 3 times a week until reaching 12 sessions.
• Paper and Pencil
Intervention of 30 minutes, 3 times a week until reaching 12 sessions.
• Conventional Therapy
Intervention of 30 minutes, 3 times a week until reaching 12 sessions.

Locations

Country	Name	City	State
Portugal	Serviço de Saúde da Região Autónoma da Madeira	Funchal	Madeira

Sponsors (2)

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

Country where clinical trial is conducted

Portugal, 

References & Publications (3)

Faria, A. L., & Bermúdez i Badia, S. (2015). Development and evaluation of a web-based cognitive task generator for personalized cognitive training: a proof of concept study with stroke patients. In REHAB 2015: 3rd Workshop on ICTs for improving Patients Research Techniques. ACM.

Faria, A. L., Vourvopoulos, A., Cameirão, M. S., Fernandes, J. C., & Bermúdez i Badia, S. (2014). An integrative virtual reality cognitive-motor intervention approach in stroke rehabilitation: a pilot study. In 10th ICDVRAT, Gothenburg, Sweden, Sept. 2-4, 2014.

Vourvopoulos, A., Faria, A. L., Ponnam, K., & Bermúdez i Badia, S. (2014). RehabCity: Design and Validation of a Cognitive Assessment and Rehabilitation Tool through Gamified Simulations of Activities of Daily Living. In 11th International Conference on Advances in Computer Entertainment Technology. Funchal, Portugal.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Crystallised Intelligence as assesed by Comprehension from the WAIS III		Baseline
Primary	Change from baseline in the Montreal Cognitive Assessment		Baseline, End (4-6 weeks) and 8-weeks follow-up
Secondary	Change from baseline in the Trail Making Test A and B		Baseline, End (4-6 weeks) and 8-weeks follow-up
Secondary	Change from baseline in the Verbal Paired Associates (WMS III)		Baseline, End (4-6 weeks) and 8-weeks follow-up
Secondary	Change from baseline in the Digit Span (WAIS III)		Baseline, End (4-6 weeks) and 8-weeks follow-up
Secondary	Change from baseline in the Symbol Search and Coding (WAIS III)		Baseline, End (4-6 weeks) and 8-weeks follow-up

External Links

•   Task Generator