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| Name | Class |
|---|---|
| Serviço de Saúde da Região Autónoma da Madeira (SESARAM), E.P.E. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR motor-cognitive task | Experimental | 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. |
|
| Standard rehabilitation | Active Comparator | The standard rehabilitation group will perform conventional motor and cognitive rehabilitation tasks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Other | Virtual reality based upper-limb motor and cognitive task |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline, End (4-6 weeks) and 4-weeks follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the Barthel Index | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergi Bermudez i Badia, PhD | Universidade da Madeira | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SESARAM | Funchal | Madeira | 9000-012 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27503215 | Background | 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Standard | Other | Standard upper-limb motor and cognitive rehabilitation tasks |
|
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) | 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) | Assessment of change from baseline in visual scanning deficits | Baseline, End (4-6 weeks) and 4-weeks follow-up |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |