Feasibility Study of a Virtual Reality Cognitive-motor Task Based on Positive Stimuli for Stroke Rehabilitation

March 4, 2017 updated by: Sergi Bermúdez i Badia, Universidade da Madeira

Interactive System for Diagnostics and Rehabilitation of Cognitive-motor Deficits: Controlled Longitudinal Clinical Study With Stroke Patients

The purpose of this study is to determine whether it is feasible to use a virtual reality task for stroke rehabilitation for training motor and cognitive (attention and memory) domains based on the use of positive stimuli, and to evaluate the potential benefits in comparison to standard rehabilitation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is evidence that positive emotion stimuli can lead to improved performance in attention tasks and the investigators aim to understand the benefits of using this principle in cognitive and upper-limb motor rehabilitation following stroke. For this purpose, the investigators developed a VR attention task in which the user has to find a target image within a variable number of distractors by controlling a virtual arm. In some levels of the task the target has to be memorized, hence training both attention and memory. The target stimuli are positive images based on the individual preferences of each user.

40 participants within the first 6 months after stroke will be randomly allocated to one of two groups: 1) VR motor-cognitive task or 2) standard rehabilitation. The VR motor-cognitive task group will use the above described virtual task customized to each user in terms of the positive content. This also includes selected music that will be introduced in half of the sessions. The standard rehabilitation group will undergo conventional motor and cognitive rehabilitation. The intervention consists of 12 sessions of 45 minutes administered within a 4-6 weeks period. The participants will be evaluated using a number motor and cognitive assessment scales at baseline, end of the intervention and a 1-month follow-up.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
    • Madeira
      • Funchal, Madeira, Portugal, 9000-012
        • SESARAM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ischemic or hemorrhagic stroke within the first 6 months post-stroke
  • motor impairment of the upper extremity but with a minimum score of 28 in the Motricity Index (elbow flexion and shoulder abduction domains combined score)
  • 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

Exclusion Criteria:

  • previous motor and/or cognitive deficits
  • normal cognitive functioning with a score above 26 points in the Montreal Cognitive Assessment
  • unilateral spatial neglect
  • moderate to severe depressive symptomatology with a score above 20 points in the Geriatric Depression Scale
  • vision disorders that may interfere with the execution of the task

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VR motor-cognitive task
The VR motor-cognitive task group will perform a virtual reality motor and cognitive attention/memory task customized to each user in terms of the positive content.
Other: Virtual Reality
Virtual reality based upper-limb motor and cognitive task
Active Comparator: Standard rehabilitation
The standard rehabilitation group will perform conventional motor and cognitive rehabilitation tasks.
Other: Standard
Standard upper-limb motor and cognitive rehabilitation tasks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the Fugl-Meyer Assessment Test (upper extremity)
Time Frame: Baseline, End (4-6 weeks) and 4-weeks follow-up
Assessment of change from baseline in motor and joint functioning of the paretic upper extremity.
Baseline, End (4-6 weeks) and 4-weeks follow-up
Change form baseline in the Chedoke Arm and Hand Activity Inventory
Time Frame: Baseline, End (4-6 weeks) and 4-weeks follow-up
Assessment of change from baseline in the functionality of the paretic upper extremity.
Baseline, End (4-6 weeks) and 4-weeks follow-up
Change from baseline in the Montreal Cognitive Assessment
Time Frame: Baseline, End (4-6 weeks) and 4-weeks follow-up
Assessment of change from baseline in cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
Baseline, End (4-6 weeks) and 4-weeks follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the Barthel Index
Time Frame: Baseline, End (4-6 weeks) and 4-weeks follow-up
Assessment of change from baseline in independence in activities of daily living.
Baseline, End (4-6 weeks) and 4-weeks follow-up
Change from baseline in the Modified Ashworth Scale
Time Frame: Baseline, End (4-6 weeks) and 4-weeks follow-up
Assessment of change from baseline in muscle spasticity of the upper extremity
Baseline, End (4-6 weeks) and 4-weeks follow-up
Change from baseline in the Motricity Index (upper extremity)
Time Frame: Baseline, End (4-6 weeks) and 4-weeks follow-up
Assessment of change from baseline in muscle power of the paretic upper extremity.
Baseline, End (4-6 weeks) and 4-weeks follow-up
Change from baseline in cancellation tests (single letter, number, bells)
Time Frame: Baseline, End (4-6 weeks) and 4-weeks follow-up
Assessment of change from baseline in visual scanning deficits
Baseline, End (4-6 weeks) and 4-weeks follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade da Madeira

Collaborators

Serviço de Saúde da Região Autónoma da Madeira (SESARAM), E.P.E.

Investigators

  • Principal Investigator: Sergi Bermudez i Badia, PhD, Universidade da Madeira

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 27, 2015

First Submitted That Met QC Criteria

August 31, 2015

First Posted (Estimate)

September 3, 2015

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 4, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 303891- 47/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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