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

Universidade da Madeira

Status: Completed

Conditions: Stroke

Treatments: Other: Standard; Other: Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT02539914

303891- 47/2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

VR motor-cognitive task

Experimental group

Description:

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.

Treatment:

Other: Virtual Reality

Standard rehabilitation

Active Comparator group

Description:

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

Treatment:

Other: Standard