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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Virtual Reality
Standard
Sponsored by
Universidade da Madeira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Virtual reality, Motor and cognitive rehabilitation, Positive emotion stimuli

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • SESARAM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VR motor-cognitive task

Standard rehabilitation

Arm 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.

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

Outcomes

Primary Outcome Measures

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.
Change form baseline in the Chedoke Arm and Hand Activity Inventory
Assessment of change from baseline in the functionality of the paretic upper extremity.
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.

Secondary Outcome Measures

Change from baseline in the Barthel Index
Assessment of change from baseline in independence in activities of daily living.
Change from baseline in the Modified Ashworth Scale
Assessment of change from baseline in muscle spasticity of the upper extremity
Change from baseline in the Motricity Index (upper extremity)
Assessment of change from baseline in muscle power of the paretic upper extremity.
Change from baseline in cancellation tests (single letter, number, bells)
Assessment of change from baseline in visual scanning deficits

Full Information

First Posted
August 27, 2015
Last Updated
March 4, 2017
Sponsor
Universidade da Madeira
Collaborators
Serviço de Saúde da Região Autónoma da Madeira (SESARAM), E.P.E.
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1. Study Identification

Unique Protocol Identification Number
NCT02539914
Brief Title
Feasibility Study of a Virtual Reality Cognitive-motor Task Based on Positive Stimuli for Stroke Rehabilitation
Official Title
Interactive System for Diagnostics and Rehabilitation of Cognitive-motor Deficits: Controlled Longitudinal Clinical Study With Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade da Madeira
Collaborators
Serviço de Saúde da Região Autónoma da Madeira (SESARAM), E.P.E.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Virtual reality, Motor and cognitive rehabilitation, Positive emotion stimuli

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VR motor-cognitive task
Arm Type
Experimental
Arm 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.
Arm Title
Standard rehabilitation
Arm Type
Active Comparator
Arm Description
The standard rehabilitation group will perform conventional motor and cognitive rehabilitation tasks.
Intervention Type
Other
Intervention Name(s)
Virtual Reality
Intervention Description
Virtual reality based upper-limb motor and cognitive task
Intervention Type
Other
Intervention Name(s)
Standard
Intervention Description
Standard upper-limb motor and cognitive rehabilitation tasks
Primary Outcome Measure Information:
Title
Change from baseline in the Fugl-Meyer Assessment Test (upper extremity)
Description
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
Title
Change form baseline in the Chedoke Arm and Hand Activity Inventory
Description
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
Title
Change from baseline in the Montreal Cognitive Assessment
Description
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
Secondary Outcome Measure Information:
Title
Change from baseline in the Barthel Index
Description
Assessment of change from baseline in independence in activities of daily living.
Time Frame
Baseline, End (4-6 weeks) and 4-weeks follow-up
Title
Change from baseline in the Modified Ashworth Scale
Description
Assessment of change from baseline in muscle spasticity of the upper extremity
Time Frame
Baseline, End (4-6 weeks) and 4-weeks follow-up
Title
Change from baseline in the Motricity Index (upper extremity)
Description
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
Title
Change from baseline in cancellation tests (single letter, number, bells)
Description
Assessment of change from baseline in visual scanning deficits
Time Frame
Baseline, End (4-6 weeks) and 4-weeks follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergi Bermudez i Badia, PhD
Organizational Affiliation
Universidade da Madeira
Official's Role
Principal Investigator
Facility Information:
Facility Name
SESARAM
City
Funchal
State/Province
Madeira
ZIP/Postal Code
9000-012
Country
Portugal

12. IPD Sharing Statement

Citations:
PubMed Identifier
27503215
Citation
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.
Results Reference
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Feasibility Study of a Virtual Reality Cognitive-motor Task Based on Positive Stimuli for Stroke Rehabilitation

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