Dynamic Ultrasound of the Calf Muscles After Stroke

NCT ID: NCT06250478

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-27
• Study Completion Date: 2024-04-04

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. is the technique feasible to perform in persons after stroke?

2. does the use of the dynamic echoprobe change gait patterns?

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.

Therefore, 10 stroke patients and 10 age- and gender-matched healthy controls will walk on a treadmill for 3x2 minutes after a familiarisation period of 6 minutes.

During 1 x 2 minutes, subjects will walk without using the dynamic ultrasound. This recording aims to measure the normal gait pattern of the subjects.

During the other 2x2 minutes, subjects will walk using the dynamic ultrasound at 2 different locations on the calf. Once with the ultrasound probe on the centre of the muscle belly to visualise muscle fibre bundles and once on the muscle tendon transition, from which muscle belly and tendon length can be derived.

The use of ultrasound or not will be randomized to exclude the effect of fatigue on the outcome measures.

Conditions

Stroke; Gait Disorders, Neurologic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Stroke patient

Group Type: EXPERIMENTAL

Dynamic ultrasound of the calf muscles

Intervention Type: DIAGNOSTIC_TEST

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

Healthy controls

Group Type: ACTIVE_COMPARATOR

Dynamic ultrasound of the calf muscles

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Dynamic ultrasound of the calf muscles

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

• healthy adults

Exclusion Criteria

• wearing ankle foot orthosis that inhibit the assessment
• had lower limb surgery in the past

• suffering from any neurological condition
• had lower limb surgery in the past

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Ghent

OTHER

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ghent University Hospital

Ghent, , Belgium

Countries

Belgium

Other Identifiers

B6702023000632

Identifier Type: REGISTRY

Identifier Source: secondary_id

ONZ-2023-0497

Identifier Type: -

Identifier Source: org_study_id