Home-based Exercises for Patients With Stroke

Not Applicable

Completed

• Conditions: Cerebrovascular Disorders; Brain Infarction; Brain Ischemia; Stroke
• Interventions: Behavioral: home-based group (HBG); Behavioral: supervised exercise group (SEG)

• Registration Number: NCT01674452
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2011-02
• Study Completion: 2012-07
• Status Verified: 2012-08
• Study First Submitted: 2012-08-13
• Study First Submitted QC: 2012-08-24
• Last Update Submitted: 2012-08-24
• Study First Posted: 2012-08-28
• Last Update Posted: 2012-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
home-based group	home-based group (HBG)	-
supervised exercise group	supervised exercise group (SEG)	-

Primary Outcome Measures

Name	Time	Method
Functional Independence Measure	6 months	Functional Independence Measure (FIM) it is an 18-item ordinal scale with seven levels ranging from 1 (total dependence) to 7 (total independence).FIM can be subdivided into a 13-item motor subscale (eating, grooming, bathing, dressing upper body, dressing lower body, personal hygiene, bladder control, bowel control, transfer to tub/shower, walk or wheelchair, stairs) and 5-item cognitive subscale (comprehension, expression, social interaction, problem solving, memory).The motor and cognitive sub-scales scores range from 13 to 91(motor-FIM) and from 5 to 35 (cognitive-FIM). The maximum total score is 126.

Secondary Outcome Measures

Name	Time	Method
motor performance, Fugl-Meyer scale	6 months	The Fugl-Meyer physical performance scale assesses five dimensions of impairment, including three aspects of motor control, such as the amplitude of joint movement, pain, sensitivity, motor impairment of the upper and lower extremities and balance. The data are scored in an ordinal scale of 3 (0=no performance; 2=complete performance) applied to each item7. The total motor score is equal to the classification of the upper limb (UL) plus the lower limb (LL), corresponding to 100 total scores (UL=66, LL=34). The total FM score, including the other items, corresponds to 226 scores in the final sum.

Trial Locations

Locations (1)

Department of Physical therapy, Medicine School of University of São Paulo; 🇧🇷 São Paulo, Brazil