StrokeNCT02065505
Method Pilates X Pilates in Water Postural Alignment and Its Correlation With Respiratory Capacity With Hemiparesis Spastic
A study testing Mat Pilates and Water Pilates in people with Stroke, run by Universidade do Vale do Paraíba at 1 site in Brazil.
Trial summary
To evaluate the efficacy of treatment with the Pilates Method in postural alignment and its correlation with the respiratory capacity of individuals with hemiparesis, with the aid of biomedical instrumentation, comparing the method performed in soil and therapy pool. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Mat Pilates and Water Pilates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having suffered cerebrovascular accident for at least two years (chronic hemiparesis) with prevalence of upper limb (middle cerebral artery);
- Spasticity grade 1, 1 + 2 by the Modified Ashworth Scale;
- Good cognition;
- Get assume a standing position
- Sign the Consent form;
- Inclusion Criteria for Healthy individuals who will make up the control group:
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- People who may be standing upright;
- Understand the activities that will be proposed
- Subscribe to the disclaimer conscentimento.
Who cannot join
- Patients with severe cardiovascular disease;
- Patients with joint deformities;
- Patients with balance disorders;
- Patients with seizures;
- Patients with hypertension;
- Patients with uncontrolled diabetes;
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- Individuals with a restriction in the liquid medium;
- Individuals with cognitive impairment that prevents an understanding of the proposed activities.
- Individuals who do not meet the age range studied;
- Patients with uncontrolled hypertension and diabetes;
- Individuals with restrictions on liquid medium;
- Subjects with any neurological disorder;
- Individuals with severe respiratory diseases;
- Individuals who have been diagnosed with severe postural imbalance.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Rehabilitation Engineering Laboratory of Sensory Motor
São José dos Campos, São Paulo
Tamires de Souza Moreira Prianti, 5512991394476, tamirescpv@hotmail.com
Tamires de Souza Moreira Prianti
About this study
Official title: METHOD PILATES x PILATES IN WATER POSTURAL ALIGNMENT AND ITS CORRELATION WITH RESPIRATORY CAPACITY WITH HEMIPARESIS SPASTIC
To evaluate the efficacy of treatment with the Pilates Method in postural alignment and its correlation with the respiratory capacity of individuals with hemiparesis, with the aid of biomedical instrumentation, comparing the method performed in soil and therapy pool.
Read the detailed description
The hemiparesis, which corresponds to muscle weakness in hemisphere contralateral to injury, is the most common disorder after stroke Brain. The most obvious implication is postural asymmetry, having direct relation to respiratory pressures are also reduced due to muscle weakness, thus altering the respiratory capacity of these individuals. The Pilates Method is gaining prominence in clinical and scientific areas, contributing to restoring good posture and vertical alignment of the body. Therefore, this study aims assess muscle electrical activity, respiratory capacity and functionality of spastic hemiparetic patients before and after application the Pilates Method, soil and therapy pool. A randomized study where 60 hemiparetic participate will be held with brachial predominance and 30 healthy subjects (Control Group), of both sexes, ages 40 to 70 years. Individuals with hemiparesis will be randomly assigned through a lottery and half held 10 consecutive sessions of Pilates in the soil and the rest will the same protocol adapted for therapy pool. The control group will be treated by the Pilates Method in the soil. The exercises will aim to lengthen musculature shortened due to postural pattern of pathology ; strengthen selected muscles that give support and postural musculature more important upper limb for activities of daily living. Participants will undergo postural assessment, activity EMG, muscle strength, respiratory capacity analysis and evaluation of the functionality of the upper limbs on the first day of treatment and after doing all sessions. The Student's t test will be used, with a significance level of 5 % to compare results obtained before and after treatment. After the tests, the Pearson correlation will also be made between the data obtained in soil and therapy pool. Thus, it is expected that Pilates can improve postural alignment and the breathable hemiparetic and the strengthening of specific muscles of the upper limbs assist in improving the functionality of them in their daily activities.
- Conditions
- Stroke
- Being tested
- Mat Pilates, Water Pilates
- Keywords
- Spastic hemiparesis, Posture, Pilates, Respiratory Capacity
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mat PilatesOther
Water PilatesOther
| Study group | Role | What they receive |
|---|---|---|
| Pilates Group Solo | Experimental | participate in this group 30 individuals who will be treated with the Pilates Method performing the exercises on the ground, using the Swiss ball and elastic bands. The exercises will aim to lengthen the musculature that are shortened due to the characteristic postural pattern of pathology (major and minor pectoral, shoulder adductors, biceps, wrist flexors, trunk side chain); strengthen the musculature that provide postural support (abdominal, middle trapezius, rhomboids, gluteus maximus, erector spinae and latissimus dorsi) and the upper limb musculature important for activities of daily living (triceps, biceps, internal rotators, external rotators and abductors of the shoulder). Receives: Other: Mat Pilates |
| Water Pilates Group | Experimental | participate in this group 30 individuals who will be treated with the Pilates method, but doing the exercises in the therapy pool, with the aid of floats and weights. The protocol of stretches and exercises will work the same muscle groups than the G1, keeping the same decubitus whenever possible. The adaptations to the exercises are justified by the physical principles of water, which at one point may act for or against the activity being performed. Receives: Other: Water Pilates |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle electrical activity before and after treatment
The electrical activity of the postural muscles will be measured before and after treatment.
Measured: 4 weeks
Secondary outcomes (2)
respiratory capacity before and after treatment
Will be measured respiratory capacity of the participants (tidal volume, residual volume, etc.) before and after treatment.
Measured: 4 weeks
higher functionality members before and after treatment
Will be measured through a range of functionality, the functionality of the upper limbs of the subjects, seeking an improvement in their activities of daily living.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startOct 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
- 60 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
- NCT02065505
- Sponsor's protocol ID
- 19284013.6.0000.5503
- Status last verified
- Feb 2014
- First submitted
- 7 Feb 2014
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- METHOD PILATES x PILATES IN WATER POSTURAL ALIGNMENT AND ITS CORRELATION WITH RESPIRATORY CAPACITY WITH HEMIPARESIS SPASTIC
- ClinicalTrials.gov ID
- NCT02065505
- Acronym / sponsor ID
- 19284013.6.0000.5503
- Conditions
- Stroke
- Keywords
- Spastic hemiparesis, Posture, Pilates, Respiratory Capacity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidade do Vale do ParaíbaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Dec 2014 (estimated)
- First posted
- 19 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.
To evaluate the efficacy of treatment with the Pilates Method in postural alignment and its correlation with the respiratory capacity of individuals with hemiparesis, with the aid of biomedical instrumentation, comparing the method performed in soil and therapy pool.
Detailed description
The hemiparesis, which corresponds to muscle weakness in hemisphere contralateral to injury, is the most common disorder after stroke Brain. The most obvious implication is postural asymmetry, having direct relation to respiratory pressures are also reduced due to muscle weakness, thus altering the respiratory capacity of these individuals. The Pilates Method is gaining prominence in clinical and scientific areas, contributing to restoring good posture and vertical alignment of the body. Therefore, this study aims assess muscle electrical activity, respiratory capacity and functionality of spastic hemiparetic patients before and after application the Pilates Method, soil and therapy pool. A randomized study where 60 hemiparetic participate will be held with brachial predominance and 30 healthy subjects (Control Group), of both sexes, ages 40 to 70 years. Individuals with hemiparesis will be randomly assigned through a lottery and half held 10 consecutive sessions of Pilates in the soil and the rest will the same protocol adapted for therapy pool. The control group will be treated by the Pilates Method in the soil. The exercises will aim to lengthen musculature shortened due to postural pattern of pathology ; strengthen selected muscles that give support and postural musculature more important upper limb for activities of daily living. Participants will undergo postural assessment, activity EMG, muscle strength, respiratory capacity analysis and evaluation of the functionality of the upper limbs on the first day of treatment and after doing all sessions. The Student's t test will be used, with a significance level of 5 % to compare results obtained before and after treatment. After the tests, the Pearson correlation will also be made between the data obtained in soil and therapy pool. Thus, it is expected that Pilates can improve postural alignment and the breathable hemiparetic and the strengthening of specific muscles of the upper limbs assist in improving the functionality of them in their daily activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates Group Solo | Experimental | Other: Mat Pilatesparticipate in this group 30 individuals who will be treated with the Pilates Method performing the exercises on the ground, using the Swiss ball and elastic bands. The exercises will aim to lengthen the musculature that are shortened due to the characteristic postural pattern of pathology (major and minor pectoral, shoulder adductors, biceps, wrist flexors, trunk side chain); strengthen the musculature that provide postural support (abdominal, middle trapezius, rhomboids, gluteus maximus, erector spinae and latissimus dorsi) and the upper limb musculature important for activities of daily living (triceps, biceps, internal rotators, external rotators and abductors of the shoulder). |
| Water Pilates Group | Experimental | Other: Water Pilatesparticipate in this group 30 individuals who will be treated with the Pilates method, but doing the exercises in the therapy pool, with the aid of floats and weights. The protocol of stretches and exercises will work the same muscle groups than the G1, keeping the same decubitus whenever possible. The adaptations to the exercises are justified by the physical principles of water, which at one point may act for or against the activity being performed. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Having suffered cerebrovascular accident for at least two years (chronic hemiparesis) with prevalence of upper limb (middle cerebral artery);
- Spasticity grade 1, 1 + 2 by the Modified Ashworth Scale;
- Good cognition;
- Get assume a standing position
- Sign the Consent form;
Key exclusion criteria (14 listed)
- Patients with severe cardiovascular disease;
- Patients with joint deformities;
- Patients with balance disorders;
- Patients with seizures;
- Patients with hypertension;
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 |
|---|---|---|
| Mat Pilates | Other | Pilates Group Solo |
| Water Pilates | Other | Water Pilates Group |
Primary outcome
muscle electrical activity before and after treatment
Time frame: 4 weeks
The electrical activity of the postural muscles will be measured before and after treatment.
2 secondary outcomes
respiratory capacity before and after treatment
Time frame: 4 weeks
higher functionality members before and after treatment
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 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 Mat Pilates and Water Pilates 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 9 inclusion and 14 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 19 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 Tamires de Souza Moreira Prianti (5512991394476, tamirescpv@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle electrical activity before and after treatment (time frame: 4 weeks). 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 19 Feb 2014.