Clinical trial NCT06250478: Dynamic Ultrasound of the Calf Muscles After Stroke
Official title: Het Gebruik Van Dynamische Echografie om Spier-pees Veranderingen te Onderzoeken in de Kuitspieren Van Personen na Een CVA: Een Pilootstudie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Gait Disorders, Neurologic
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2024-02-09
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Both stroke patients and age and gender matched healthy controls will be included
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Stroke group Inclusion criteria

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

Exclusion criteria

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

Healthy volunteers Inclusion criteria

- healthy adults

Exclusion criteria

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

Primary outcomes:
measure: Fascicle dynamics measured with ultrasound during walking
timeFrame: single point assessment in one day during walking with the probe
measure: Muscle belly dynamics measured with ultrasound during walking
timeFrame: single point assessment in one day during walking with the probe
measure: Tendon dynamics measured with ultrasound during walking
timeFrame: single point assessment in one day during walking with the probe
Secondary outcomes:
measure: gait speed
timeFrame: single point assessment in one day during walking with the probe
measure: gait speed
timeFrame: single point assessment in one day during walking without the probe
measure: step width
timeFrame: single point assessment in one day during walking with the probe
measure: step width
timeFrame: single point assessment in one day during walking without the probe
measure: Step length
timeFrame: single point assessment in one day during walking with the probe
measure: Step length
timeFrame: single point assessment in one day during walking without the probe
measure: stance phase
timeFrame: single point assessment in one day during walking with the probe
measure: stance phase
timeFrame: single point assessment in one day during walking without the probe
measure: swing phase
timeFrame: single point assessment in one day during walking with the probe
measure: swing phase
timeFrame: single point assessment in one day during walking without the probe
measure: lower limb kinematics
timeFrame: single point assessment in one day during walking with the probe
measure: lower limb kinematics
timeFrame: single point assessment in one day during walking without the probe
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
References: