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

Stroke Clinical Trial

Official title:

METHOD PILATES x PILATES IN WATER POSTURAL ALIGNMENT AND ITS CORRELATION WITH RESPIRATORY CAPACITY WITH HEMIPARESIS SPASTIC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02065505
• Other study ID #: 19284013.6.0000.5503
• Status: Recruiting
• Phase: N/A
• First received: February 7, 2014
• Last updated: February 14, 2014
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2014
• Source: Universidade do Vale do Paraíba
• Contact: Tamires de Souza Moreira Prianti
• Phone: 5512991394476
• Email: tamirescpv[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Mat Pilates

• Water Pilates

Locations

Country	Name	City	State
Brazil	Rehabilitation Engineering Laboratory of Sensory Motor	São José dos Campos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Vale do Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle electrical activity before and after treatment	The electrical activity of the postural muscles will be measured before and after treatment.	4 weeks	No
Secondary	respiratory capacity before and after treatment	Will be measured respiratory capacity of the participants (tidal volume, residual volume, etc.) before and after treatment.	4 weeks	No
Secondary	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.	4 weeks	No