An interventional study of Virtual Reality and Standard in Stroke, sponsored by Universidade da Madeira. Completed at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-07.
Sponsored by Universidade da Madeira · Not applicable, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 18 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Universidade da Madeira is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
The standard rehabilitation group will perform conventional motor and cognitive rehabilitation tasks.
Other: Standard
Virtual reality based upper-limb motor and cognitive task
Standard upper-limb motor and cognitive rehabilitation tasks
Change from baseline in the Fugl-Meyer Assessment Test (upper extremity)
Assessment of change from baseline in motor and joint functioning of the paretic upper extremity.
Time frame: Baseline, End (4-6 weeks) and 4-weeks follow-up
Change form baseline in the Chedoke Arm and Hand Activity Inventory
Assessment of change from baseline in the functionality of the paretic upper extremity.
Time frame: Baseline, End (4-6 weeks) and 4-weeks follow-up
Change from baseline in the Montreal Cognitive Assessment
Assessment of change from baseline in cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
Time frame: Baseline, End (4-6 weeks) and 4-weeks follow-up
Change from baseline in the Barthel Index
Assessment of change from baseline in independence in activities of daily living.
Time frame: Baseline, End (4-6 weeks) and 4-weeks follow-up
Change from baseline in the Modified Ashworth Scale
Assessment of change from baseline in muscle spasticity of the upper extremity
Time frame: Baseline, End (4-6 weeks) and 4-weeks follow-up
Change from baseline in the Motricity Index (upper extremity)
Assessment of change from baseline in muscle power of the paretic upper extremity.
Time frame: Baseline, End (4-6 weeks) and 4-weeks follow-up
Change from baseline in cancellation tests (single letter, number, bells)
Assessment of change from baseline in visual scanning deficits
Time frame: Baseline, End (4-6 weeks) and 4-weeks follow-up
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Universidade da Madeira