Skip to main content
OpenTrials
Completed

NCT Number: NCT03588832

Prevalence of Postural Patterns of Upper Extremity.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spasticity as Sequela of Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Upper Extremity Paresis Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad de La Frontera

Temuco, 4780000, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Evaluation Upper Extremity patterns.

Diagnostic Test

The procedure involves evaluating subjects who meet the eligibility criteria and agree to participate in the study by signing informed consent. The study includes a measurement, applying a registration form, the Barthel scale and the FIM scale.

Other names: Evaluation upper extremity patterns after stroke.

Primary outcomes

  1. Clinical record

    Time frame: 3 months

    Document created by the study team that seeks to collect clinical information from the sample, including the evaluation of the classification of patterns.

Secondary outcomes

  1. Evaluation of Quality of life.

    Time frame: 3 months

    These will be evaluated through the:

    Barthel Index that assesses the quality of life with respect to performing ADL. The values assigned to each activity depend on the time spent and help to carry it out.

    The activities are valued differently, being able to assign 0, 5, 10 or 15 points. The global range can vary between 0, completely dependent, and 100 points, completely independent.

  2. Evaluation of functionality.

    Time frame: 3 months

    These will be evaluated through the:

    Scale Functional Independence Measure (FIM) Evaluates the functional independence given through the activities of daily life (ADL). It consists of 18 items that cover two areas: motor activity (13 items) and cognitive skills (5 items). Each item is evaluated according to seven options ranging from 1 (total attendance) to 7 (total independence). The total score range goes from 18 to 126 points.

Other outcomes

  1. Spasticity evaluation

    Time frame: 3 months

    Evaluation using the Ashwort Scale. This graduates the tone from 0 (no increase in tone) to 4 (rigid extremity in flexion or extension), it is based on the examiner manually moving a limb of the patient, in the whole of the possible joint range and perceive the resistance that a muscle offers when stretched.

Sponsors and collaborators

Lead sponsor

Universidad de La Frontera

Other

Registry information

Official study title

Prevalence of Postural Patterns of Upper Extremity and Its Impact on the Quality of Life of Patients Sequelae of a Stroke.

Acronym: Patterns

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 17, 2018
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.