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

Stroke Clinical Trial

Official title:

Interactive System for Diagnostics and Rehabilitation of Cognitive-motor Deficits: Controlled Longitudinal Clinical Study With Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02539914
• Other study ID #: 303891- 47/2013
• Status: Completed
• Phase: N/A
• First received: August 27, 2015
• Last updated: March 4, 2017
• Start date: June 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: Universidade da Madeira
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Virtual Reality
Virtual reality based upper-limb motor and cognitive task
• Standard
Standard upper-limb motor and cognitive rehabilitation tasks

Locations

Country	Name	City	State
Portugal	SESARAM	Funchal	Madeira

Sponsors (2)

Lead Sponsor	Collaborator
Universidade da Madeira	Serviço de Saúde da Região Autónoma da Madeira (SESARAM), E.P.E.

Country where clinical trial is conducted

Portugal, 

References & Publications (1)

Faria AL, Cameirao MS, Paulino T, Bermudez i Badia S. The benefits of emotional stimuli in a virtual reality cognitive and motor rehabilitation task: Assessing the impact of positive, negative and neutral stimuli with stroke patients. International Conference on Virtual Rehabilitation (ICVR), 2015.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	Change from baseline in the Modified Ashworth Scale	Assessment of change from baseline in muscle spasticity of the upper extremity	Baseline, End (4-6 weeks) and 4-weeks follow-up
Secondary	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
Secondary	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