Clinical trial NCT03588832: Prevalence of Postural Patterns of Upper Extremity.
Official title: Prevalence of Postural Patterns of Upper Extremity and Its Impact on the Quality of Life of Patients Sequelae of a Stroke.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spasticity as Sequela of Stroke
Stroke
Upper Extremity Paresis
Keywords: Stroke
Spasticity
Upper Extremity
Quality of Life
Lead sponsor: Universidad de La Frontera
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It will consist of 600 subjects with a diagnosis of stroke who attend comprehensive rehabilitation centers in regions V, VIII, IX and X in Chile.

Brief summary: A high number of patient with stroke develops spasticity of the upper extremity, this clinical sign of damage of 1 motoneuro (MN), causes postures and patterns of abnormal movement, due to the hyperexcitability of the MN and the rheological alterations that occur in the affected muscles. These alterations limit the use of upper extremity, restricting its use in functional activities and affecting the quality of life and social participation of the users. During the last few years the classification of the Hefter patterns for spasticity of the upper limb was created, with the end of having a common language and orienting the current therapeutic strategies oriented towards the arm.

Objective: To determine the prevalence of patterns and their impact on the quality of life of patients after a stroke.

Material and method: Descriptive design of cross section, the sample will be composed of 600 people who attend integral rehabilitation center of regions V, VIII, IX and X in Chile, that meet the inclusion criteria and sign the informed consent. The study will include a measurement made by a trained professional from each participating center using a registration form, the FIM scale and the Barthel index, to assess quality of life.

Results: It will be analyzed with the SPSS software through descriptive and inferential statistics considering the nature of the variables, all the analyzes will consider as statistically significant the results with p values less than or equal to 0.05. Depending on the interval or ordinal level of the measurements, the coefficients r of Pearson and rho of Spearman will be used to calculate the correlations.

Applicability: The results will determine the prevalence in this geographical sector, disseminate this classification and promote the use of a common language among professionals to enhance their daily work. In addition, it will allow to determine how the affectation of the upper extremity through the identification of a certain pattern alters the quality of life of the patient. This new information can be a fundamental input in the generation of future studies that seek to guide in relation to the use of therapeutic strategies in these people.

Detailed description: The impact generated by spasticity in the performance of functional activities in post-stroke patients is undeniable. Given the above, it is essential to evaluate this construct, considering the impact it has on the ADL. There are numerous scales that allow evaluating how spasticity affects post-stroke functionality, even helping to detect which beneficial aspects of spasticity should be considered when defining a therapeutic strategy. Among the most used scales are the Barthel Index, which assesses the level of patient independence with respect to the performance of some ADL. The scientific evidence suggests that patients with spasticity have low rates in Barthel.

The scientific evidence suggests that a careful and continuous evaluation of spasticity, would allow to identify establishment times and affected structures; as well as, to recognize predictive factors that assist rehabilitation professionals, identifying which patients are predisposed to develop spasticity, in order to reduce the risk of its establishment and influence its evolution, helping to identify preventive measures and effective interventions, that allow to achieve better motor and functional results, promoting its application in search of an optimal recovery.

Given the above, the purpose of the study is to determine the prevalence of patterns and their impact on the quality of life of patients after sequelae of a stroke. The generation of new scientific evidence acquires vital importance and are key to the management of these patients.

Eligibility criteria: Inclusion Criteria:

* Age between 20 and 85 years, with no previous history of motor disability.
* Diagnosis of ischemic or hemorrhagic stroke.
* Voluntarily accept participation in the study through the signing of informed consent, either personally or through a family member.

Exclusion Criteria:

* Presenting musculoskeletal pathology in the affected arm.

Primary outcomes:
measure: Clinical record
timeFrame: 3 months
Secondary outcomes:
measure: Evaluation of Quality of life.
timeFrame: 3 months
measure: Evaluation of functionality.
timeFrame: 3 months
Other outcomes:
measure: Spasticity evaluation
timeFrame: 3 months
Locations:
city: Temuco
country: Chile
facility: Universidad de La Frontera
Study officials:
affiliation: U Frontera
name: Arlette P Doussoulin, PhD
role: PRINCIPAL_INVESTIGATOR
References: