NCT06411587Completed
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
Source: ClinicalTrials.gov · Last updated 22 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 52 (actual)
- First submitted
- 8 Mar 2024
- Start date
- 27 Feb 2024
- Primary completion date
- 1 Dec 2024
- Lead sponsor
- Universidad de Zaragoza
- Diseases
- Stroke
- NCT number
- NCT06411587
What you commit to
- Study type: Observational
- Participants enrolled: 52
- From 27 Feb 2024 to the primary completion date, 1 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Surgical intervention in the lower limb.
- Previous diagnosis of stroke.
- Surgical intervention in the lower limb.
Other illness
- 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 medical conditions that may interfere with data interpretation.
- Group of non-stroke patients
- 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 medical conditions that may interfere with data interpretation.
Other
- Other neurological pathologies (e.g., ataxia or dystonia).
- Cognitive impairments that hinder study measurements.
- Presence of spasticity in any part of the body.
- Other neurological pathologies (e.g., ataxia or dystonia).
- Cognitive impairments that hinder study measurements.
Who the study is looking for
- 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.
- Age over 18 years
- Be able to walk independently with or without assistance
Criteria the registry did not label
- Group of patients diagnosed with ischemic or hemorrhagic stroke.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universidad de Zaragoza Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.