- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02065505
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
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
Interventional
Enrollment (Anticipated)
60
Phase
- 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 Locations
-
-
São Paulo
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São José dos Campos, São Paulo, Brazil
- Recruiting
- Rehabilitation Engineering Laboratory of Sensory Motor
-
Contact:
- Tamires de Souza Moreira Prianti
- Phone Number: 5512991394476
- Email: tamirescpv@hotmail.com
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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
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 |
Intervention / Treatment |
|---|---|
|
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).
|
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
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
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
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
October 1, 2013
Primary Completion (Actual)
February 1, 2014
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
February 7, 2014
First Submitted That Met QC Criteria
February 14, 2014
First Posted (Estimate)
February 19, 2014
Study Record Updates
Last Update Posted (Estimate)
February 19, 2014
Last Update Submitted That Met QC Criteria
February 14, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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