Dynamic Ultrasound of the Calf Muscles After Stroke

NCT06250478 | Completed

• 2 other identifiers: ONZ-2023-0497B6702023000632
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Muscle behaviour of calf muscles can be studied during dynamic conditions using dynamic ultrasound. In particular, the medial gastrocnemius is suitable for measurements with dynamic ultrasound due to its superficial location. With this measurement technique, the muscle behavior during walking can be observed gaining insight into the mechanism of action of this muscle during a functional task. This technique has already been used in other populations (such as children with cerebral palsy) but not yet in individuals after a stroke. Therefore, the aim of this study is to assess the muscle behavior of the medial gastrocnemius during walking in persons after stroke. There are 3 concrete objectives of the current study:

1. 1.is the technique feasible to perform in persons after stroke?
2. 2.does the use of the dynamic echoprobe change gait patterns?
3. 3.can differences between persons after stroke and healthy controls be detected? This data can be used as pilot data for project applications in the future that will allow to design larger studies.

Conditions

Stroke; Gait Disorders, Neurologic

Outcome Measures

Primary Outcomes (3)

• Fascicle dynamics measured with ultrasound during walking

  Lengthening and shortening of the fascicles of the medial gastrocnemius

  single point assessment in one day during walking with the probe

• Muscle belly dynamics measured with ultrasound during walking

  Lengthening and shortening of the muscle belly of the medial gastrocnemius

  single point assessment in one day during walking with the probe

• Tendon dynamics measured with ultrasound during walking

  Lengthening and shortening of the tendon of the medial gastrocnemius

  single point assessment in one day during walking with the probe

Secondary Outcomes (12)

• gait speed

  single point assessment in one day during walking with the probe

• gait speed

  single point assessment in one day during walking without the probe

• step width

  single point assessment in one day during walking with the probe

• step width

  single point assessment in one day during walking without the probe

• Step length

  single point assessment in one day during walking with the probe

Study Arms (2)

Stroke patient

EXPERIMENTAL

Diagnostic Test: Dynamic ultrasound of the calf muscles

Healthy controls

ACTIVE COMPARATOR

Diagnostic Test: Dynamic ultrasound of the calf muscles

Interventions

Dynamic ultrasound of the calf muscles DIAGNOSTIC_TEST

Dynamic changes of the calf muscles during walking will be assessed in persons after stroke and compared to healthy controls

Healthy controls; Stroke patient

Eligibility Criteria

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

You may qualify if:

• stroke adults
• no other neurologic conditions
• ability to walk independently on a treadmill

You may not qualify if:

• wearing ankle foot orthosis that inhibit the assessment
• had lower limb surgery in the past
• \- healthy adults
• suffering from any neurological condition
• had lower limb surgery in the past

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Both stroke patients and age and gender matched healthy controls will be included

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 9, 2024
• Study Start: February 27, 2024
• Primary Completion: April 4, 2024
• Study Completion: April 4, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)