Home-based Exercises for Patients With Stroke
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2010
Typical duration for not_applicable
1 active site
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
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 13, 2012
CompletedFirst Posted
Study publicly available on registry
August 28, 2012
CompletedAugust 28, 2012
August 1, 2012
1.1 years
August 13, 2012
August 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Functional Independence Measure
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.
6 months
Secondary Outcomes (1)
motor performance, Fugl-Meyer scale
6 months
Study Arms (3)
home-based group
EXPERIMENTALsupervised exercise group
ACTIVE COMPARATORcontrol
NO INTERVENTIONControl group:no intervention
Interventions
Participants in the home-based group (HBG) were advised to exercise, a minimum of 4 times per week, but they were encouraged to exercise a total of 5-7 days per week. After individual assessment, a group of home-exercise selected of the manual was explained and performed one by one. The home-exercises were re-executed at each fortnightly visit, when necessary corrections were made and the next step stipulated by manual was taken, according to the patient's progress.
Patients in the supervised exercise training group (SEG) participated in supervised individual exercise sessions 2 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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- severe cognitive impairment
- Commodity that preclude them from undergoing training and assessment
- Neurological disease other than stroke
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Physical therapy, Medicine School of University of São Paulo
São Paulo, São Paulo, 05360-000, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Maria Elisa P Piemonte
Department of Physical therapy,School of Medicine, University of Sao Paulo
- PRINCIPAL INVESTIGATOR
Tatiana P Oliveira
Department of Physical therapy, School of Medicine, University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PT; PhD
Study Record Dates
First Submitted
August 13, 2012
First Posted
August 28, 2012
Study Start
January 1, 2010
Primary Completion
February 1, 2011
Study Completion
July 1, 2012
Last Updated
August 28, 2012
Record last verified: 2012-08