StrokeNCT03583827
Motor Learning of Stroke Patients in Virtual Environments
A study testing Virtual reality and Conventional physical therapy in people with Stroke and Stroke Sequelae, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
The aim of this study is to assess the motor learning of patients with chronic stroke in virtual environments. Half the patients will undergo conventional therapy and half virtual reality training using virtual game. The study will also include healthy individuals matched for age, sex, schooling and hand laterality. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Stroke Sequelae
- What is being tested?
- Virtual reality and Conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Feb 2014to 1 Feb 2020
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects diagnosed with the first episode of stroke, confirmed by medical imaging examination, unilateral brain injury, lesion time of at least 6 months;
- Right-handed and able to complete the assessment instruments;
- Individuals with affected upper limb movement skills, such as drinking water from a glass;
- Subjects able to remain in the orthostatic position, with or without gait assistive device.
Who cannot join
- Unilateral neglect and uncorrected primary auditory or visual impairment.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Department of Physical Therapy-Federal University of Rio Grande do Norte
Natal, Rio Grande do Norte, 59078-970
Jacilda O Passos, MS, +55 84 987121765, jacilda_band@hotmail.com
Lorenna DM Borges, MS, +55 84 987234630, lorennamacedo@gmail.com
About this study
Official title: Motor Learning of Stroke Patients in Virtual Environments: Randomized Controlled Clinical Trial
The aim of this study is to assess the motor learning of patients with chronic stroke in virtual environments. Half the patients will undergo conventional therapy and half virtual reality training using virtual game. The study will also include healthy individuals matched for age, sex, schooling and hand laterality.
Read the detailed description
Stroke is the main cause of long-term disability in adults and motor learning is vital for recovering from motor sequelae. A number of approaches have been proposed to promote motor learning, including virtual reality, which simulates a real world environment and is based on the assumption that skills acquired in a virtual world will be transferred to the real world. Virtual reality induces use-dependent plastic changes in response to stimulation of higher motor areas, recruiting the memory system containing stored motor programs. As such, these interactive interventions of virtual reality are based on the idea that stimulating the action processing system activates the cortical areas involved in movement execution.
These game characteristics allow activation of the mirror neuron system during the execution or observation of actions. Recent evidence suggests an important role for this neuron system in the improvement or motor recovery of patients. In this respect, observing an action in association with physical training may enhance the effects of motor training on the recovery of patients with stroke.
- Conditions
- Stroke, Stroke Sequelae
- Being tested
- Virtual reality, Conventional physical therapy
- Keywords
- Cerebrovascular disorders, Upper extremity, Paresis, Electroencephalography, Psychomotor Performance
- Medical subject headings
- Stroke, Cerebrovascular Disorders, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityOther
Also called Virtual game
Virtual reality is a simulation of the real world generated by computer software and experienced by users via a man-machine interface, providing them with intensive repetition of complex tasks, directed by visual and auditory stimuli, creating dynamic individual-task interaction, a motivating environment and immediate feedback on performance and results, stimulating motor skill learning and motor control of complex behaviors.
Conventional physical therapyOther
Also called Traditional physical therapy
Exercises of stretching and strengthening of the upper and lower limbs, as well as coordination, gait and balance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Experimental group patients will be submitted to conventional therapy for 30 minutes and training of the affected upper limb using virtual reality, which will last 20 minutes over twelve sessions (4 weeks). Receives: Other: Virtual reality; Other: Conventional physical therapy |
| Control Group | Active comparator | The control group will undergo 30 minutes of Conventional physical therapy in twelve sessions (4 weeks). Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change the angle of movement
Angle of extension of the elbow joint (in degrees) measured before and after the intervention.
Measured: Change from baseline until 30 days.
Secondary outcomes (2)
Change the EEG power of alpha and beta waves
EEG power of alpha and beta waves (uV2) measured before and after the intervention.
Measured: Change from baseline until 30 days.
Change the Absolute error
Absolute error evaluated by score which may vary from 0 (no error, the dart hits the central target) to 5 (maximum error, the dart does not hits the target).
Measured: Change from 15 trials during 20 minutes over twelve sessions (4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start10 Feb 2014
- Primary completion20 Nov 2019
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Eighty unilaterally brain injured right-handed patients, with lesion time of 6 months or more, aged 70 years or younger, 40 with left-brain and 40 with right-brain injury, will take part in the study. They will be randomly divided into a control group (GC), which will undergo conventional therapy and an experimental group (EG), which will be submitted to conventional and virtual reality training using the game virtual. The study will also include 40 healthy individuals matched for age, sex, schooling and hand laterality.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Tania Campos, Universidade Federal do Rio Grande do Norte
- Investigators
- Tania F Campos, PhD, Study director, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583827
- Sponsor's protocol ID
- 475182/2012-0
- Status last verified
- Nov 2019
- First submitted
- 7 Jun 2018
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Learning of Stroke Patients in Virtual Environments: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03583827
- Acronym / sponsor ID
- 475182/2012-0
- Conditions
- Stroke, Stroke Sequelae
- Keywords
- Cerebrovascular disorders, Upper extremity, Paresis, Electroencephalography, Psychomotor Performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 10 Feb 2014 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 11 Jul 2018 (actual)
- 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 aim of this study is to assess the motor learning of patients with chronic stroke in virtual environments. Half the patients will undergo conventional therapy and half virtual reality training using virtual game. The study will also include healthy individuals matched for age, sex, schooling and hand laterality.
Detailed description
Stroke is the main cause of long-term disability in adults and motor learning is vital for recovering from motor sequelae. A number of approaches have been proposed to promote motor learning, including virtual reality, which simulates a real world environment and is based on the assumption that skills acquired in a virtual world will be transferred to the real world. Virtual reality induces use-dependent plastic changes in response to stimulation of higher motor areas, recruiting the memory system containing stored motor programs. As such, these interactive interventions of virtual reality are based on the idea that stimulating the action processing system activates the cortical areas involved in movement execution.
These game characteristics allow activation of the mirror neuron system during the execution or observation of actions. Recent evidence suggests an important role for this neuron system in the improvement or motor recovery of patients. In this respect, observing an action in association with physical training may enhance the effects of motor training on the recovery of patients with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eighty unilaterally brain injured right-handed patients, with lesion time of 6 months or more, aged 70 years or younger, 40 with left-brain and 40 with right-brain injury, will take part in the study. They will be randomly divided into a control group (GC), which will undergo conventional therapy and an experimental group (EG), which will be submitted to conventional and virtual reality training using the game virtual. The study will also include 40 healthy individuals matched for age, sex, schooling and hand laterality.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Virtual reality, Other: Conventional physical therapyExperimental group patients will be submitted to conventional therapy for 30 minutes and training of the affected upper limb using virtual reality, which will last 20 minutes over twelve sessions (4 weeks). |
| Control Group | Active comparator | Other: Conventional physical therapyThe control group will undergo 30 minutes of Conventional physical therapy in twelve sessions (4 weeks). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects diagnosed with the first episode of stroke, confirmed by medical imaging examination, unilateral brain injury, lesion time of at least 6 months;
- Right-handed and able to complete the assessment instruments;
- Individuals with affected upper limb movement skills, such as drinking water from a glass;
- Subjects able to remain in the orthostatic position, with or without gait assistive device.
Key exclusion criteria (1 listed)
- Unilateral neglect and uncorrected primary auditory or visual impairment.
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 realityAlso: Virtual gameVirtual reality is a simulation of the real world generated by computer software and experienced by users via a man-machine interface, providing them with intensive repetition of complex tasks, directed by visual and auditory stimuli, creating dynamic individual-task interaction, a motivating environment and immediate feedback on performance and results, stimulating motor skill learning and motor control of complex behaviors. | Other | Experimental Group |
| Conventional physical therapyAlso: Traditional physical therapyExercises of stretching and strengthening of the upper and lower limbs, as well as coordination, gait and balance. | Other | Control Group, Experimental Group |
Primary outcome
Change the angle of movement
Time frame: Change from baseline until 30 days.
Angle of extension of the elbow joint (in degrees) measured before and after the intervention.
2 secondary outcomes
Change the EEG power of alpha and beta waves
Time frame: Change from baseline until 30 days.
Change the Absolute error
Time frame: Change from 15 trials during 20 minutes over twelve sessions (4 weeks).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Tania F Campos, PhD study director
Universidade Federal do Rio Grande do Norte
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 Conventional physical therapy in people with Stroke and Stroke Sequelae, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 3 Dec 2019. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aline GS Fernandes, PhD (+55 84 999862403, linebraga_fisio@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change the angle of movement (time frame: Change from baseline until 30 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2019.