Predictors Factors and Time of Onset of Spasticity and Their Relationship With the Functionality and Quality of Life.
NCT ID: NCT03459066
Last Updated: 2020-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2018-10-01
2020-10-30
Brief Summary
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Identify times and characteristics of appearance; as well as its predictive factors can support an early intervention, orienting and strengthening the work of the rehabilitation team.
Determine the times of establishment, location and factors that favor the development of spasticity in acute stage and how it influences the functionality, quality of life and emotional level of post-stroke patients in hospital facilities.
Through this proposal, it is proposed to generate a new line of research that allows the development of scientific evidence in the area of neurorehabilitation, specifically in the field of spasticity, through the identification of establishment times, affected structures and predominant patterns in the extremities; as well as determining factors that favor the development of spasticity and its impact on post-stroke functionality and quality of life.
This information will strengthen the rehabilitative process of these subjects and the actions of the rehabilitation team, supporting the identification of preventive measures and implementing effective interventions that allow achieving better motor and functional results, in search of an optimal recovery.
Detailed Description
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The sample will consist of 150 subjects who meet the inclusion criteria, sign the informed consent and who will be treated during the year 2018 at the Hospital and the Clinic.
The study will include three measurement times: Time 1, during the first 10 days of hospitalization (T1); Time 2, at 3 months after T1; and Time 3, at 12 months after T1.
At each time of measurement, the study variables will be evaluated by 4 professionals trained in the following instruments: the Ashworth Scale to assess spasticity; To measure global functionality, the Barthel Index will be applied and, to assess functionality of the upper extremity, the Action Research Arm scale will be used; The Quality of Life Scale for Stroke-38 will be used to assess quality of life and emotional level. In addition, in time 1 the sociodemographic and clinical characteristics of the sample will be evaluated through a clinical record prepared for this purpose.
Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Institution-Group 8 district
Group of patients belonging to institutions of district 8. Patients will be evaluated in 3 different times with different assessment instruments for tone, functionality and quality of life.
Institution-Group
The study includes three measurement times:
* Time 1 (T1): corresponds to the first measurement, which will take place between the 3rd and 10th day of hospitalization.
* Time 2 (T2): corresponds to the second measurement, which will be carried out 3 months after the first measurement.
* Time 3 (T3): corresponds to the third measurement, which will be carried out 12 months after the first measurement.
The evaluations will be tone, functionality and quality of life.
Institution-Group 9 district
Group of patients belonging to institutions of district 9. Patients will be evaluated in 3 different times with different assessment instruments for tone, functionality and quality of life.
Institution-Group
The study includes three measurement times:
* Time 1 (T1): corresponds to the first measurement, which will take place between the 3rd and 10th day of hospitalization.
* Time 2 (T2): corresponds to the second measurement, which will be carried out 3 months after the first measurement.
* Time 3 (T3): corresponds to the third measurement, which will be carried out 12 months after the first measurement.
The evaluations will be tone, functionality and quality of life.
Institution-Group 10 district
Group of patients belonging to institutions of district 10. Patients will be evaluated in 3 different times with different assessment instruments for tone, functionality and quality of life.
Institution-Group
The study includes three measurement times:
* Time 1 (T1): corresponds to the first measurement, which will take place between the 3rd and 10th day of hospitalization.
* Time 2 (T2): corresponds to the second measurement, which will be carried out 3 months after the first measurement.
* Time 3 (T3): corresponds to the third measurement, which will be carried out 12 months after the first measurement.
The evaluations will be tone, functionality and quality of life.
Interventions
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Institution-Group
The study includes three measurement times:
* Time 1 (T1): corresponds to the first measurement, which will take place between the 3rd and 10th day of hospitalization.
* Time 2 (T2): corresponds to the second measurement, which will be carried out 3 months after the first measurement.
* Time 3 (T3): corresponds to the third measurement, which will be carried out 12 months after the first measurement.
The evaluations will be tone, functionality and quality of life.
Eligibility Criteria
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Inclusion Criteria
* Being hospitalized with a diagnosis of ischemic or hemorrhagic stroke in the acute period.
* Present a history with a single stroke event confirmed by Computerized Axial Tomography.
* Without severe cognitive commitment, that is, score greater than 14 on the MiniMental Abbreviated scale.
* Stable hemodynamically.
* Voluntarily accept participation in the study through the signing of informed consent, either personally or through a family member.
Exclusion Criteria
* Have a medical contraindication.
20 Years
80 Years
ALL
No
Sponsors
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Universidad de La Frontera
OTHER
Responsible Party
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ARLETTE PATRICIA DOUSSOULIN SANHUEZA
Dr. Arlette Doussoulin
Principal Investigators
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Arlette Doussoulin, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad de La Frontera
Locations
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Universidad de La Frontera
Temuco, , Chile
Countries
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Other Identifiers
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Spasticity Factors
Identifier Type: -
Identifier Source: org_study_id