Clinical trial NCT03459066: Predictors Factors and Time of Onset of Spasticity and Their Relationship With the Functionality and Quality of Life.
Official title: Predictive Factors and Time of Onset of Spasticity in Post-stroke Patients and Their Relationship With the Functionality and Quality of Life.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Stroke Spasticity
Keywords: Spasticity
Stroke
Predictors
Functionality
Quality of life
Lead sponsor: Universidad de La Frontera
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It will be constituted by all the subjects with a medical diagnosis of stroke in the acute phase, attended during 2018 at the Dr. Hernán Henríquez Aravena Hospital and the Alemana Clinic.

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.

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.

Eligibility criteria: Inclusion Criteria:

* Have an age between 20 and 80 years, with no previous history of motor disability.
* 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:

* Present sensitive aphasia.
* Have a medical contraindication.

Primary outcomes:
measure: Ashworth Scale
timeFrame: 6 months
measure: Action Research Arm
timeFrame: 6 months
measure: Barthel Index
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Temuco
country: Chile
facility: Universidad de La Frontera
Study officials:
affiliation: Universidad de La Frontera
name: Arlette Doussoulin, PhD
role: PRINCIPAL_INVESTIGATOR
References: