Morphological Characteristics of the Upper and Lower Extremities Using Ultrasound Examination After Stroke.

NCT07156760 | Completed

• 1 other identifier: DIUFRO FONDOS PROPIOS 240045
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Introduction A large number of stroke patients develop spasticity in the upper and lower extremities, which is one of the clinical signs of damage to motor neuron 1, causing abnormal postures and movement patterns due to motor neuron hyperexcitability and rheological alterations in the affected muscles. These alterations limit the use of the arm and leg, restricting their use in functional activities and affecting the quality of life and social participation of users. In recent years, the Heckmann scale has been used to evaluate spastic muscle alterations by ultrasound; however, evidence is limited regarding its benefits as an assessment tool for spastic hypertonia. Objective To describe the morphological characteristics of spastic muscles in the lower extremities using ultrasound examination in subjects after stroke. Method A prospective, multicenter descriptive study will be conducted. The sample will be non-probabilistic, consisting of 80 subjects who meet the eligibility criteria and provide informed consent. Analysis of results Using the SPSS 27 program, a descriptive analysis will be performed using statistical indices of central tendency, dispersion, and distribution according to the measurement scale of each variable. The normality of the distribution of continuous variables will be investigated. In addition, a bivariate correlation analysis (ANOVA) will be performed. The significance level will be 0.05. Expected Results It will provide updated evidence in the field of assessing the state of spastic muscles in subjects with neurological damage, a situation that will guide the therapeutic process and may improve the patient's prognosis and quality of life.

Conditions

Stroke

Keywords

stroke; Spasticity Muscle; Ultrasound diagnostics

Outcome Measures

Primary Outcomes (1)

• Spasticity

  Modified Ashworth Scale (MAS) The scale measures resistance during passive soft-tissue stretching. Lower values mean less spasticity Scoring: 0 - No increase in muscle tone. 1 - Slight increase in muscle tone, manifested by a catch and release at the end of the range of motion when the affected part(s) are moved in flexion or extension. 1+ - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion. 2 - More marked increase in muscle tone through most of the range of motion, but affected part(s) easily moved. 3 - Considerable increase in muscle tone, passive movement difficult. 4 - Affected part(s) rigid in flexion or extension.

  Outcome measure: Day 1, prior to the ultrasound scan. The results report will be issued 1 month after the analysis, sharing the analysis with participating centers and patients. On average, 1 year after the start of the study.

Secondary Outcomes (2)

• Spasticity

  Day 1, prior to the ultrasound scan. The results report will be issued 1 month after the analysis, sharing the analysis with participating centers and patients. On average, 1 year after the start of the study.

• Morphological characteristics

  Day 1, after the initial assessment. 5 patients per day, completing 15 per week at each center. Total intervention time, through study completion, an average of 6 months.

Interventions

Ultrasound diagnostics DIAGNOSTIC_TEST

Non-invasive ultrasound evaluation of the upper limb on the hemiplegic side (Ekipomed Portable Ultrasound) to determine its pathological morphology (thickness, fiber orientation, and echogenicity) using the modified Heckmatt scale. This procedure will be performed by a physician who is an expert in muscle ultrasound.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult stroke patients with spasticity.

You may qualify if:

• Patients over 18 years of age with a history of stroke more than three months ago.
• Who are undergoing or have undergone some type of rehabilitation in the acute and/or subacute stage.
• Who present spastic hypertonia in the upper and lower extremities detectable by Ashworth and Tardieu assessment.
• Presence of spastic pattern according to Hefter classification.
• Who agree to participate in the study and sign the consent form.

You may not qualify if:

• Structural joint involvement that prevents tone assessment.
• Patients who have been injected with antispastic drugs in the last 6 months.

Sponsors & Collaborators

• Universidad de La Frontera: lead

Study Sites (2)

Universidad de La Frontera

Temuco, Araucania, 4780000, Chile

Location

Universidad de La Frontera

Temuco, 478000, Chile

Location

Related Publications (3)

• Doussoulin A, Rivas R, Sabelle C. [Hospital discharges due to stroke in the period 2001-2010 in a southern Chilean region]. Rev Med Chil. 2016 May;144(5):571-6. doi: 10.4067/S0034-98872016000500003. Spanish.

  PMID: 27552006 BACKGROUND

• Trompetto C, Marinelli L, Mori L, Pelosin E, Curra A, Molfetta L, Abbruzzese G. Pathophysiology of spasticity: implications for neurorehabilitation. Biomed Res Int. 2014;2014:354906. doi: 10.1155/2014/354906. Epub 2014 Oct 30.

  PMID: 25530960 BACKGROUND

• Li S. Spasticity, Motor Recovery, and Neural Plasticity after Stroke. Front Neurol. 2017 Apr 3;8:120. doi: 10.3389/fneur.2017.00120. eCollection 2017.

  PMID: 28421032 BACKGROUND

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

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

Study Officials

• Arlette P. Doussoulin, PhD

  Universidad de La Frontera

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: September 5, 2025
• Study Start: March 1, 2025
• Primary Completion: April 1, 2025
• Study Completion: December 31, 2025
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

CL (2)