Analysis of the Correlation Between Ultrasound Imaging and Functional Parameters in the Medial Gastrocnemius Muscle in Post-stroke Patients With Spasticity in the Lower Limb

NCT06411587 | Completed

• 1 other identifier: US-function
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to understand the impact of spasticity on muscle changes and functional performance in stroke patients with lower limb spasticity in comparison to non-stroke individuals. The main questions it aims to answer are:

• How does spasticity affect muscle changes and lower limb functional performance in stroke patients?
• How do structural and textural parameters in ultrasound images differ between spastic stroke patients and non-stroke individuals? Participants will undergo ultrasound evaluation of their leg muscles to measure structural and textural parameters. They will also take part in functional assessments to assess their performance in activities related to lower limb mobility. Researchers will compare the structural and textural ultrasound parameters between stroke patients and non-stroke individuals to determine any notable differences. The study aims to identify the relationship between muscle changes, spasticity, and functional performance in stroke patients.

Conditions

Stroke; Spasticity, Muscle

Keywords

Stroke; Ultrasound imaging; Spasticity, muscle; Function

Outcome Measures

Primary Outcomes (1)

• Muscle thickness

  It is the distance between the superficial and deep layer of the fascia of the medial gastrocnemius. It is considered one of the 3 muscular architecture parameters that will be measured using ultrasound images collected with the Butterfly iQ+ portable device by Butterfly Network, Inc., a company located in the United Kingdom. The device is connected to a tablet from which the images are visualized and captured. For more information about the device, you can visit the following link: www.butterflynetwork.com/int/es-es/individual

  Through study completion, an average of 1 year

Secondary Outcomes (8)

• Fascicle length

  Through study completion, an average of 1 year

• Pennation angle

  Through study completion, an average of 1 year

• Concurrence matrices

  Through study completion, an average of 1 year

• Degree of spasticity

  Through study completion, an average of 1 year

• Functional capacity

  Through study completion, an average of 1 year

Study Arms (2)

Patients with stroke

Patients with a chronic stroke and spasticity in the ankle flexors muscles.

Diagnostic Test: Ultrasound imaging and functional assessment

Patients without stroke

Patients without stroke were matched with those with stroke based on age and sex.

Diagnostic Test: Ultrasound imaging and functional assessment

Interventions

Ultrasound imaging and functional assessment DIAGNOSTIC_TEST

Participants in this study will undergo two types of assessments: capturing muscle images using ultrasound and evaluating their function through clinical scales.

Patients with stroke; Patients without stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stroke group: patients diagnosed with ischemic or hemorrhagic stroke who follow the selection criteria. Non-stroke group: patients without a diagnosis of stroke matching with each member of the stroke group.

You may qualify if:

• Age over 18 years
• Present spasticity in the plantar flexor muscles of the ankle as a result of a first unilateral ischemic or hemorrhagic stroke (excluding subarachnoid hemorrhage, as it is not truly a stroke) diagnosed by computed tomography or magnetic resonance imaging.
• Have more than 6 months of evolution since the onset of the cerebrovascular accident (chronic stroke).
• Degree of spasticity on the Modified Ashworth Scale (MAS): 1, 1+, 2, or 3.
• Be able to walk independently with or without assistance.

You may not qualify if:

• Other musculoskeletal or neurological disorders affecting the lower limb (bilateral stroke, peripheral neuropathy, peripheral nerve injury, myopathy, severe osteoarthritis, recent muscle injury, recent bone fracture, joint replacement, fixed contractures involving the affected leg, bone deformities of the lower limbs).
• Other neurological pathologies (e.g., ataxia or dystonia).
• Surgical intervention in the lower limb.
• Cognitive impairments that hinder study measurements.
• Other medical conditions that may interfere with data interpretation.
• Group of non-stroke patients
• Age over 18 years
• Be able to walk independently with or without assistance
• Previous diagnosis of stroke.
• Presence of spasticity in any part of the body.
• Other musculoskeletal or neurological disorders affecting the lower limb (bilateral stroke, peripheral neuropathy, peripheral nerve injury, myopathy, severe osteoarthritis, recent muscle injury, recent bone fracture, joint replacement, fixed contractures involving the affected leg, bone deformities of the lower limbs).
• Other neurological pathologies (e.g., ataxia or dystonia).
• Surgical intervention in the lower limb.
• Cognitive impairments that hinder study measurements.
• Other medical conditions that may interfere with data interpretation.

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (1)

Universidad de Zaragoza

Zaragoza, Aragon, 50009, Spain

Location

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Interventions

Ultrasonography

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

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Pablo Herrero Gallego, Physical Therapist

  Universidad de Zaragoza

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and PhD

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: May 13, 2024
• Study Start: February 27, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 30, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-04

Locations

ES (1)