StrokeNCT02539914
Feasibility Study of a Virtual Reality Cognitive-motor Task Based on Positive Stimuli for Stroke Rehabilitation
A study testing Virtual Reality and Standard in people with Stroke, run by Universidade da Madeira at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Virtual Reality and Standard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 sitePortugal
- Study dates
- Jun 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interactive System for Diagnostics and Rehabilitation of Cognitive-motor Deficits: Controlled Longitudinal Clinical Study With Stroke Patients
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Virtual Reality, Standard
- Keywords
- Virtual reality, Motor and cognitive rehabilitation, Positive emotion stimuli
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
Virtual reality based upper-limb motor and cognitive task
StandardOther
Standard upper-limb motor and cognitive rehabilitation tasks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Virtual Reality |
| Standard rehabilitation | Active comparator | The standard rehabilitation group will perform conventional motor and cognitive rehabilitation tasks. Receives: Other: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, End (4-6 weeks) and 4-weeks follow-up
Secondary outcomes (4)
Change from baseline in the Barthel Index
Assessment of change from baseline in independence in activities of daily living.
Measured: 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
Measured: 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.
Measured: 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
Measured: Baseline, End (4-6 weeks) and 4-weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade da Madeira
- Sponsor type
- University, hospital or other
- Collaborators
- Serviço de Saúde da Região Autónoma da Madeira (SESARAM), E.P.E.
- Responsible party
- Principal investigator, Sergi Bermúdez i Badia, Universidade da Madeira
- Investigators
- Sergi Bermudez i Badia, PhD, Principal investigator, Universidade da Madeira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539914
- Sponsor's protocol ID
- 303891- 47/2013
- Status last verified
- Mar 2017
- First submitted
- 27 Aug 2015
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27503215
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive System for Diagnostics and Rehabilitation of Cognitive-motor Deficits: Controlled Longitudinal Clinical Study With Stroke Patients
- ClinicalTrials.gov ID
- NCT02539914
- Acronym / sponsor ID
- 303891- 47/2013
- Conditions
- Stroke
- Keywords
- Virtual reality, Motor and cognitive rehabilitation, Positive emotion stimuli
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universidade da MadeiraUniversity, hospital or other
- Collaborators
- Serviço de Saúde da Região Autónoma da Madeira (SESARAM), E.P.E.
- Study start
- Jun 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 3 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR motor-cognitive task | Experimental | Other: Virtual RealityThe 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 | Other: StandardThe standard rehabilitation group will perform conventional motor and cognitive rehabilitation tasks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityVirtual reality based upper-limb motor and cognitive task | Other | VR motor-cognitive task |
| StandardStandard upper-limb motor and cognitive rehabilitation tasks | Other | Standard rehabilitation |
Primary outcome
Change from baseline in the Fugl-Meyer Assessment Test (upper extremity)
Time frame: 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
Time frame: 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
Time frame: 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.
4 secondary outcomes
Change from baseline in the Barthel Index
Time frame: Baseline, End (4-6 weeks) and 4-weeks follow-up
Change from baseline in the Modified Ashworth Scale
Time frame: Baseline, End (4-6 weeks) and 4-weeks follow-up
Change from baseline in the Motricity Index (upper extremity)
Time frame: Baseline, End (4-6 weeks) and 4-weeks follow-up
Change from baseline in cancellation tests (single letter, number, bells)
Time frame: Baseline, End (4-6 weeks) and 4-weeks follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Background: PubMed 27503215Cameirao 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergi Bermudez i Badia, PhD principal investigator
Universidade da Madeira
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Standard in people with Stroke, run by Universidade da Madeira at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Fugl-Meyer Assessment Test (upper extremity) (time frame: Baseline, End (4-6 weeks) and 4-weeks follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02539914, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.