Predictors Factors and Time of Onset of Spasticity and Their Relationship With the Functionality and Quality of Life.

Predictive Factors and Time of Onset of Spasticity in Post-stroke Patients and Their Relationship With the Functionality and Quality of Life.

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.

Study Overview

• Status: Completed
• Conditions: Post Stroke Spasticity
• Intervention / Treatment: Diagnostic test: Institution-Group

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Chile
  • Temuco, Chile, 4780000
    • Universidad de La Frontera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: 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.	Diagnostic test: 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.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ashworth Scale	Instrument used in the assessment of spasticity. 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 (in the clinical setting it is use 1 second to perform the complete joint travel) and perceive the resistance that a muscle offers when stretched.	6 months
Action Research Arm	This Instrument was constructed to determine the functional recovery of the upper limb. It is composed of 19 items grouped in 4 subtest, including each subtest: 6 items of grip, 4 items taken, 6 items of clip, 3 items of thick movement. All the items are evaluated with a scale of 4 points from 0 to 3, where 0 represents no movement and 3 normal movement for the task.	6 months
Barthel Index	Scale that assesses the level of patient independence with respect to performing Activity Daily Life. 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.	6 months

Collaborators and Investigators

• Sponsor: Universidad de La Frontera

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ACTUAL): March 30, 2019
• Study Completion (ACTUAL): October 30, 2020

Study Registration Dates

• First Submitted: March 2, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (ACTUAL): March 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Stroke; Quality of life; Functionality; Spasticity; Predictors
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Stroke; Muscle Spasticity
• Other Study ID Numbers: Spasticity Factors

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We have not decided this item.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No