Clinical trial NCT01674452: Home-based Exercises for Patients With Stroke
Official title: Home-based Exercises for Patients With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Disorders
Brain Infarction
Brain Ischemia
Stroke
Keywords: Stroke
Exercise and Physical Fitness
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2012-08-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the development and the implementation of a new protocol about home-based exercises, supported by an illustrated manual, for the treatment of individuals with stroke.

The hypothesis is that this group of patients who are going to carry out the training of this study protocol are going to show improvement in measured parameters (functionality and physical performance), which allows this protocol to be improved and published as a proposal of physiotherapeutic treatment.

Detailed description: 1. 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.
2. 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.
3. 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of stroke, confirmed by clinical and radiological evidence
* Ability to understand and follow commands
* willing and able to regularly attend a supervised exercise program

Exclusion Criteria:

* severe cognitive impairment
* Commodity that preclude them from undergoing training and assessment
* Neurological disease other than stroke

Primary outcomes:
measure: Functional Independence Measure
timeFrame: 6 months
Secondary outcomes:
measure: motor performance, Fugl-Meyer scale
timeFrame: 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Department of Physical therapy, Medicine School of University of São Paulo
Study officials:
affiliation: Department of Physical therapy,School of Medicine, University of Sao Paulo
name: Maria Elisa P Piemonte
role: STUDY_DIRECTOR
affiliation: Department of Physical therapy, School of Medicine, University of Sao Paulo
name: Tatiana P Oliveira
role: PRINCIPAL_INVESTIGATOR
References: