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Home-based Exercises for Patients With Stroke

U

University of Sao Paulo General Hospital

Status

Completed

Conditions

Brain Ischemia
Stroke
Brain Infarction
Cerebrovascular Disorders

Treatments

Behavioral: home-based group (HBG)
Behavioral: supervised exercise group (SEG)

Study type

Interventional

Funder types

Other

Identifiers

NCT01674452
USPNEC003

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 3 patient groups

home-based group
Experimental group
Treatment:
Behavioral: home-based group (HBG)
supervised exercise group
Active Comparator group
Treatment:
Behavioral: supervised exercise group (SEG)
control
No Intervention group
Description:
Control group:no intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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