StrokeNCT02061371
Virtual Therapy in Rehabilitation Spastic Hemiparesis
A study testing virtual therapy and conventional physiotherapy in people with Stroke, run by Universidade do Vale do Paraíba at 1 site in Brazil.
Trial summary
Evaluate the effectiveness of virtual therapy and conventional physiotherapy in spastic muscles of patients with sequelae of stroke. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- virtual therapy and conventional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2013to Dec 2014
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical referral for physiotherapy;
- Maximum grade 2 spasticity in the upper and lower limbs according to the Modified Ashworth Scale;
- Total passive range of elbow joint and knee to the movement of flexion and extension;
- Independent ambulation, with or without support;
- Cognitive preserved, being able to respond to the command of the examiner;
- Least 6 months of injury;
Who cannot join
- Active infection, and rash at the site of application of NMES;
- Visual and hearing impairment;
- Joint stiffness and musculoskeletal injuries of the elbow and knee,
- Inability to interpret the therapeutic resources to be displayed;
- Presenting lesions in areas of Wernick and drill;
- Uncontrolled hypertension.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Lersm, Ip&D
São José dos Campos, São Paulo, 12244-000
Ana Carolina Borges, masters students, 5512981014448, carolborges.fisio@gmail.com
About this study
Official title: VIRTUAL THERAPY IN REHABILITATION SPASTIC HEMIPARESIS
Evaluate the effectiveness of virtual therapy and conventional physiotherapy in spastic muscles of patients with sequelae of stroke.
Read the detailed description
Considered the second most frequent cause of death worldwide , the stroke is also responsible for the largest number of functional disability in individuals. The socio - economic hardship that many patients face to perform a program of intensive rehabilitation sensorimotor, has led to functional limitations in many cases , promote irreversible consequences. Spasticity in the upper and lower limb after stroke results in loss of function and mobility being the key therapeutic approaches in order to restore its function. Currently, the Virtual therapy has been used in physical therapy, demonstrating safety, feasibility and potential to facilitate the effective rehabilitation treatment, promoting motor recovery. The objective of this study is to analyze and compare the effectiveness of virtual therapy and conventional physiotherapy in paretic upper and lower limbs of patients with sensory motor deficit after stroke. Virtual therapy will be based on a custom application using virtual reality projection, and conventional treatment will be based on cinesiotherapy for members upper and lower paretic. The evaluation will be performed by biomedical instrumentation using dynamometry, electromyography and analysis from functional movement. Statistical differences are based on t test with significance level of p 0 , 05 . As a result expected - scientifically proven the effectiveness of this new form of treatment aimed at improving quality of life and functional independence of patients with neurological sequel.
- Conditions
- Stroke
- Being tested
- virtual therapy, conventional physiotherapy
- Keywords
- stroke, spasticity, physiotherapy, virtual reality
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual therapyOther
conventional physiotherapyOther
| Study group | Role | What they receive |
|---|---|---|
| virtual therapy | Experimental | Group 1 (G1) included 20 patients who will carry out the virtual therapy. Receives: Other: virtual therapy |
| conventional physiotherapy | Experimental | Group 2 (G2) included 20 patients who hold conventional physiotherapy. Receives: Other: conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Espasticity
It is believed that this study achieves positive results regarding the adequacy of muscle tone associated with musculoskeletal better performance, so that the muscles normotônicos gain strength and overcome the resistance of the hypertonic muscles, improving range of motion and harmony of the affected limbs, leading the consequent improvement of balance and gait, after application of virtual therapy.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionFeb 2014
- Study completionDec 2014 (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
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061371
- Sponsor's protocol ID
- 20749113.5.0000.5503
- Status last verified
- Jan 2014
- First submitted
- 7 Feb 2014
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIRTUAL THERAPY IN REHABILITATION SPASTIC HEMIPARESIS
- ClinicalTrials.gov ID
- NCT02061371
- Acronym / sponsor ID
- 20749113.5.0000.5503
- Conditions
- Stroke
- Keywords
- stroke, spasticity, physiotherapy, virtual reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidade do Vale do ParaíbaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Dec 2014 (estimated)
- First posted
- 12 Feb 2014 (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.
Evaluate the effectiveness of virtual therapy and conventional physiotherapy in spastic muscles of patients with sequelae of stroke.
Detailed description
Considered the second most frequent cause of death worldwide , the stroke is also responsible for the largest number of functional disability in individuals. The socio - economic hardship that many patients face to perform a program of intensive rehabilitation sensorimotor, has led to functional limitations in many cases , promote irreversible consequences. Spasticity in the upper and lower limb after stroke results in loss of function and mobility being the key therapeutic approaches in order to restore its function. Currently, the Virtual therapy has been used in physical therapy, demonstrating safety, feasibility and potential to facilitate the effective rehabilitation treatment, promoting motor recovery. The objective of this study is to analyze and compare the effectiveness of virtual therapy and conventional physiotherapy in paretic upper and lower limbs of patients with sensory motor deficit after stroke. Virtual therapy will be based on a custom application using virtual reality projection, and conventional treatment will be based on cinesiotherapy for members upper and lower paretic. The evaluation will be performed by biomedical instrumentation using dynamometry, electromyography and analysis from functional movement. Statistical differences are based on t test with significance level of p 0 , 05 . As a result expected - scientifically proven the effectiveness of this new form of treatment aimed at improving quality of life and functional independence of patients with neurological sequel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual therapy | Experimental | Other: virtual therapyGroup 1 (G1) included 20 patients who will carry out the virtual therapy. |
| conventional physiotherapy | Experimental | Other: conventional physiotherapyGroup 2 (G2) included 20 patients who hold conventional physiotherapy. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Medical referral for physiotherapy;
- Maximum grade 2 spasticity in the upper and lower limbs according to the Modified Ashworth Scale;
- Total passive range of elbow joint and knee to the movement of flexion and extension;
- Independent ambulation, with or without support;
- Cognitive preserved, being able to respond to the command of the examiner;
Key exclusion criteria (6 listed)
- Active infection, and rash at the site of application of NMES;
- Visual and hearing impairment;
- Joint stiffness and musculoskeletal injuries of the elbow and knee,
- Inability to interpret the therapeutic resources to be displayed;
- Presenting lesions in areas of Wernick and drill;
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 therapy | Other | virtual therapy |
| conventional physiotherapy | Other | conventional physiotherapy |
Primary outcome
Espasticity
Time frame: 4 months
It is believed that this study achieves positive results regarding the adequacy of muscle tone associated with musculoskeletal better performance, so that the muscles normotônicos gain strength and overcome the resistance of the hypertonic muscles, improving range of motion and harmony of the affected limbs, leading the consequent improvement of balance and gait, after application of virtual therapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
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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.
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 therapy and conventional physiotherapy in people with Stroke, run by Universidade do Vale do Paraíba 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 6 inclusion and 6 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 12 Feb 2014. 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 Ana Carolina Borges, masters students (5512981014448, carolborges.fisio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Espasticity (time frame: 4 months). 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 12 Feb 2014.