NCT02065505

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 19, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

4 months

First QC Date

February 7, 2014

Last Update Submit

February 14, 2014

Conditions

Stroke

Keywords

Spastic hemiparesisPosturePilatesRespiratory Capacity

Outcome Measures

Primary Outcomes (1)

  • muscle electrical activity before and after treatment

    The electrical activity of the postural muscles will be measured before and after treatment.

    4 weeks

Secondary Outcomes (2)

  • respiratory capacity before and after treatment

    4 weeks

  • higher functionality members before and after treatment

    4 weeks

Study Arms (2)

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).

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.

Other: Water Pilates

Interventions

Mat PilatesOTHER
Pilates Group Solo
Water PilatesOTHER
Water Pilates Group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Engineering Laboratory of Sensory Motor

São José dos Campos, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Tamires de Souza Moreira Prianti

CONTACT

5512991394476tamirescpv@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2014

First Posted

February 19, 2014

Study Start

October 1, 2013

Primary Completion

February 1, 2014

Study Completion

December 1, 2014

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations

BR(1)