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

NCT03459066 | Completed DMC

• 1 other identifier: Spasticity Factors
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Stroke Spasticity

Keywords

Spasticity; Stroke; Predictors; Functionality; Quality of life

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

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

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

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

Interventions

Institution-Group DIAGNOSTIC_TEST

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; Institution-Group 8 district; Institution-Group 9 district

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Present sensitive aphasia.
• Have a medical contraindication.

Sponsors & Collaborators

• Universidad de La Frontera: lead

Study Sites (1)

Universidad de La Frontera

Temuco, 4780000, Chile

Location

MeSH Terms

Conditions

Muscle Spasticity; Stroke

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Arlette Doussoulin, PhD

  Universidad de La Frontera

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Arlette Doussoulin

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 8, 2018
• Study Start: October 1, 2018
• Primary Completion: March 30, 2019
• Study Completion: October 30, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Locations

CL (1)