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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Virtual Reality; Other: Standard

• Registration Number: NCT02539914
• Lead Sponsor: Universidade da Madeira

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-08-27
• Study First Submitted QC: 2015-08-31
• Study First Posted: 2015-09-03
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-04
• Last Update Posted: 2017-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR motor-cognitive task	Virtual Reality	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	Standard	The standard rehabilitation group will perform conventional motor and cognitive rehabilitation tasks.

Primary Outcome Measures

Name	Time	Method
Change from baseline in the Fugl-Meyer Assessment Test (upper extremity)	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.
Change form baseline in the Chedoke Arm and Hand Activity Inventory	Baseline, End (4-6 weeks) and 4-weeks follow-up	Assessment of change from baseline in the functionality of the paretic upper extremity.
Change from baseline in the Montreal Cognitive Assessment	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

SESARAM; 🇵🇹 Funchal, Madeira, Portugal