Dynamic Ultrasound of the Calf Muscles After Stroke

Stroke Clinical Trial

— Stroke_DynUS  

Official title:

Het Gebruik Van Dynamische Echografie om Spier-pees Veranderingen te Onderzoeken in de Kuitspieren Van Personen na Een CVA: Een Pilootstudie

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06250478
• Other study ID #: ONZ-2023-0497
• Secondary ID: B6702023000632
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2024
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Nervous System Diseases
• Stroke

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	gait speed	walking velocity (m/s)	single point assessment in one day during walking with the probe
Secondary	gait speed	walking velocity (m/s)	single point assessment in one day during walking without the probe
Secondary	step width	step width (m)	single point assessment in one day during walking with the probe
Secondary	step width	step width (m)	single point assessment in one day during walking without the probe
Secondary	Step length	Step length (m) of the paretic and non paretic side	single point assessment in one day during walking with the probe
Secondary	Step length	Step length (m) of the paretic and non paretic side	single point assessment in one day during walking without the probe
Secondary	stance phase	time spend standing on the paretic and non-paretic leg (s) during walking	single point assessment in one day during walking with the probe
Secondary	stance phase	time spend standing on the paretic and non-paretic leg (s) during walking	single point assessment in one day during walking without the probe
Secondary	swing phase	time spend not standing on the paretic and non-paretic leg (s) during walking	single point assessment in one day during walking with the probe
Secondary	swing phase	time spend not standing on the paretic and non-paretic leg (s) during walking	single point assessment in one day during walking without the probe
Secondary	lower limb kinematics	joint angles (°) in the pelvis, hip, knee and ankle in the sagittal, frontal and transverse plane during walking	single point assessment in one day during walking with the probe
Secondary	lower limb kinematics	joint angles (°) in the pelvis, hip, knee and ankle in the sagittal, frontal and transverse plane during walking	single point assessment in one day during walking without the probe