Method Pilates X Pilates in Water Postural Alignment and Its Correlation With Respiratory Capacity With Hemiparesis Spastic

February 14, 2014 updated by: Universidade do Vale do Paraíba

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
    • São Paulo
      • São José dos Campos, São Paulo, Brazil
        • Recruiting
        • Rehabilitation Engineering Laboratory of Sensory Motor
        • Contact:
        • Principal Investigator:
          • Tamires de Souza Moreira Prianti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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:

  • People who may be standing upright;
  • Understand the activities that will be proposed
  • Subscribe to the disclaimer conscentimento.

Exclusion Criteria:

  • Patients with severe cardiovascular disease;
  • Patients with joint deformities;
  • Patients with balance disorders;
  • Patients with seizures;
  • Patients with hypertension;
  • Patients with uncontrolled diabetes;
  • Individuals with a restriction in the liquid medium;
  • Individuals with cognitive impairment that prevents an understanding of the proposed activities.

Exclusion criteria for the control group:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pilates Group Solo
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).
Other: Mat Pilates
Experimental: Water Pilates Group
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.
Other: Water Pilates

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
respiratory capacity before and after treatment
Time Frame: 4 weeks
Will be measured respiratory capacity of the participants (tidal volume, residual volume, etc.) before and after treatment.
4 weeks
higher functionality members before and after treatment
Time Frame: 4 weeks
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade do Vale do Paraíba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19284013.6.0000.5503

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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