Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-28 @ 12:39 PM
Study NCT ID:
NCT03459066
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2018-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors Factors and Time of Onset of Spasticity and Their Relationship With the Functionality and Quality of Life.
Sponsor:
Universidad de La Frontera
Organization:
Study Overview
Official Title:
Predictive Factors and Time of Onset of Spasticity in Post-stroke Patients and Their Relationship With the Functionality and Quality of Life.
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Spasticity is part of the syndrome motor neuron following a Stroke. It is a clinical sign of great complexity that generates disability, limiting the function and altering the quality of life of the subjects, generating great impact on families and society.
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.
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:
A correlational (non-experimental), longitudinal, prospective follow-up design will be used for descriptive and predictive purposes.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: