Completed

Home-based Exercises for Patients With Stroke

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

home-based group (HBG)

+ supervised exercise group (SEG)

Behavioral
Who is being recruted

Behavior+13

+ Brain Diseases

+ Cardiovascular Diseases

From 18 to 75 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2010
See protocol details

Summary

Principal SponsorUniversity of Sao Paulo General Hospital
Last updated: August 28, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2010

Actual date on which the first participant was enrolled.

Program Development: 27 exercises were selected, based on the most frequent motor alterations present in hemiparesis. Three modes were created for each exercise: assisted active, active and resisted active executions. Besides explanatory text, there were illustrative photos for all exercises and their modes. Program Execution: All groups were submitted to a motor evaluation utilizing the Fugl-Meyer Assessment (FMA) and functional evaluation utilizing the Functional independence measure (FIM). After assessment, for the patients of the home-based exercise group (HBG) a group of home exercises was selected for each patient; these exercises were explained and performed one by one. The home-exercises were re-executed at each fortnightly visit, when any necessary correction was made. The next steps stipulated by the manual were taken, providing the patients with more complex exercises according to their progress. The patients in the supervised exercise training group (SEG) participated in supervised individual exercise sessions two times per week. A physical therapist supervised these sessions. Exercise sessions included: 30 minutes of global exercises that involved stretching, range of motion, muscle strengthen and another 30 minutes of functional training (gait, balance and use of the arm in daily activities).The control group (CG) was assessed but reluctant or unable to regularly attend a supervised exercise program. The groups were reassessed after six months. Program assessment: The Fugl-Meyer Assessment score and the Functional independence measure score, measured at baseline and after six months, were compared between the groups.

Principal SponsorUniversity of Sao Paulo General Hospital
Last updated: August 28, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

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

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesInfarctionIschemiaNecrosisNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesBrain IschemiaCerebrovascular DisordersMotor ActivityBrain InfarctionStroke

Criteria

3 inclusion criteria required to participate
Ability to understand and follow commands

Diagnosis of stroke, confirmed by clinical and radiological evidence

willing and able to regularly attend a supervised exercise program

3 exclusion criteria prevent from participating
Commodity that preclude them from undergoing training and assessment

Neurological disease other than stroke

severe cognitive impairment

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Group III

No Intervention
Control group:no intervention

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Department of Physical therapy, Medicine School of University of São Paulo

São Paulo, BrazilOpen Department of Physical therapy, Medicine School of University of São Paulo in Google Maps
CompletedOne Study Center