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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Virtual Reality
Paper and Pencil
Conventional Therapy
Sponsored by
Universidade da Madeira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Virtual Reality, Cognitive Rehabilitation, Motor Rehabilitation, Ecological validity, Personalisation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Serviço de Saúde da Região Autónoma da Madeira

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Virtual Reality

Paper and Pencil

Conventional Therapy

Arm Description

The Virtual Reality group will perform personalised activities of daily living in the context of a simulated city (Reh@City). The interaction with the virtual environment will be through a natural user interface.

The paper and pencil group will perform a set of cognitive paper and pencil tasks personalised to their deficits and generated automatically through a Task Generator.

The Conventional Therapy group will perform the activities offered by the public health system, which are motor-focused.

Outcomes

Primary Outcome Measures

Change from baseline in the Montreal Cognitive Assessment

Secondary Outcome Measures

Change from baseline in the Trail Making Test A and B
Change from baseline in the Verbal Paired Associates (WMS III)
Change from baseline in the Digit Span (WAIS III)
Change from baseline in the Symbol Search and Coding (WAIS III)

Full Information

First Posted
August 3, 2016
Last Updated
October 11, 2019
Sponsor
Universidade da Madeira
Collaborators
Serviço de Saúde da Região Autónoma da Madeira (SESARAM), E.P.E.
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1. Study Identification

Unique Protocol Identification Number
NCT02857803
Brief Title
A Randomised Controlled Trial Comparing the Impact of Virtual Reality, Paper and Pencil and Conventional Methods on Stroke Rehabilitation
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
January 8, 2019 (Actual)
Study Completion Date
January 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade da Madeira
Collaborators
Serviço de Saúde da Região Autónoma da Madeira (SESARAM), E.P.E.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Virtual Reality, Cognitive Rehabilitation, Motor Rehabilitation, Ecological validity, Personalisation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
The Virtual Reality group will perform personalised activities of daily living in the context of a simulated city (Reh@City). The interaction with the virtual environment will be through a natural user interface.
Arm Title
Paper and Pencil
Arm Type
Active Comparator
Arm Description
The paper and pencil group will perform a set of cognitive paper and pencil tasks personalised to their deficits and generated automatically through a Task Generator.
Arm Title
Conventional Therapy
Arm Type
Active Comparator
Arm Description
The Conventional Therapy group will perform the activities offered by the public health system, which are motor-focused.
Intervention Type
Procedure
Intervention Name(s)
Virtual Reality
Intervention Description
Intervention of 30 minutes, 3 times a week until reaching 12 sessions.
Intervention Type
Procedure
Intervention Name(s)
Paper and Pencil
Intervention Description
Intervention of 30 minutes, 3 times a week until reaching 12 sessions.
Intervention Type
Procedure
Intervention Name(s)
Conventional Therapy
Intervention Description
Intervention of 30 minutes, 3 times a week until reaching 12 sessions.
Primary Outcome Measure Information:
Title
Change from baseline in the Montreal Cognitive Assessment
Time Frame
Baseline, End (4-6 weeks) and 8-weeks follow-up
Secondary Outcome Measure Information:
Title
Change from baseline in the Trail Making Test A and B
Time Frame
Baseline, End (4-6 weeks) and 8-weeks follow-up
Title
Change from baseline in the Verbal Paired Associates (WMS III)
Time Frame
Baseline, End (4-6 weeks) and 8-weeks follow-up
Title
Change from baseline in the Digit Span (WAIS III)
Time Frame
Baseline, End (4-6 weeks) and 8-weeks follow-up
Title
Change from baseline in the Symbol Search and Coding (WAIS III)
Time Frame
Baseline, End (4-6 weeks) and 8-weeks follow-up
Other Pre-specified Outcome Measures:
Title
Crystallised Intelligence as assesed by Comprehension from the WAIS III
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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: Neglect Severe depressive symptoms as assessed by the Beck Depression Inventory
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergi Bermudez i Badia, PhD
Organizational Affiliation
Universidade da Madeira
Official's Role
Principal Investigator
Facility Information:
Facility Name
Serviço de Saúde da Região Autónoma da Madeira
City
Funchal
State/Province
Madeira
ZIP/Postal Code
9004-514
Country
Portugal

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
32546251
Citation
Faria AL, Pinho MS, Bermudez I Badia S. A comparison of two personalization and adaptive cognitive rehabilitation approaches: a randomized controlled trial with chronic stroke patients. J Neuroeng Rehabil. 2020 Jun 16;17(1):78. doi: 10.1186/s12984-020-00691-5.
Results Reference
derived
Links:
URL
http://neurorehabilitation.m-iti.org/TaskGenerator/
Description
Task Generator

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

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