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

NCT ID: NCT02539914

Last Updated: 2017-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-12-31

Brief Summary

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.

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: OTHER

Virtual reality based upper-limb motor and cognitive task

Standard rehabilitation

The standard rehabilitation group will perform conventional motor and cognitive rehabilitation tasks.

Group Type: ACTIVE_COMPARATOR

Standard

Intervention Type: OTHER

Standard upper-limb motor and cognitive rehabilitation tasks

Interventions

Virtual Reality

Virtual reality based upper-limb motor and cognitive task

Intervention Type: OTHER

Standard

Standard upper-limb motor and cognitive rehabilitation tasks

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

UNKNOWN

Sponsor Role: collaborator

Universidade da Madeira

OTHER

Sponsor Role: lead

Responsible Party

Sergi Bermúdez i Badia

Professor Auxiliar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sergi Bermudez i Badia, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade da Madeira

Locations

SESARAM

Funchal, Madeira, Portugal

Countries

Portugal

References

Cameirao MS, Faria AL, Paulino T, Alves J, Bermudez I Badia S. The impact of positive, negative and neutral stimuli in a virtual reality cognitive-motor rehabilitation task: a pilot study with stroke patients. J Neuroeng Rehabil. 2016 Aug 9;13(1):70. doi: 10.1186/s12984-016-0175-0.

Reference Type: BACKGROUND

PMID: 27503215 (View on PubMed)

Other Identifiers

303891- 47/2013

Identifier Type: -

Identifier Source: org_study_id