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Completed

NCT Number: NCT06250478

Dynamic Ultrasound of the Calf Muscles After Stroke

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Fascicle dynamics measured with ultrasound during walking

    Time frame: single point assessment in one day during walking with the probe

    Lengthening and shortening of the fascicles of the medial gastrocnemius

  2. Muscle belly dynamics measured with ultrasound during walking

    Time frame: single point assessment in one day during walking with the probe

    Lengthening and shortening of the muscle belly of the medial gastrocnemius

  3. Tendon dynamics measured with ultrasound during walking

    Time frame: single point assessment in one day during walking with the probe

    Lengthening and shortening of the tendon of the medial gastrocnemius

Secondary outcomes

  1. gait speed

    Time frame: single point assessment in one day during walking with the probe

    walking velocity (m/s)

  2. gait speed

    Time frame: single point assessment in one day during walking without the probe

    walking velocity (m/s)

  3. step width

    Time frame: single point assessment in one day during walking with the probe

    step width (m)

  4. step width

    Time frame: single point assessment in one day during walking without the probe

    step width (m)

  5. Step length

    Time frame: single point assessment in one day during walking with the probe

    Step length (m) of the paretic and non paretic side

  6. Step length

    Time frame: single point assessment in one day during walking without the probe

    Step length (m) of the paretic and non paretic side

  7. stance phase

    Time frame: single point assessment in one day during walking with the probe

    time spend standing on the paretic and non-paretic leg (s) during walking

  8. stance phase

    Time frame: single point assessment in one day during walking without the probe

    time spend standing on the paretic and non-paretic leg (s) during walking

  9. swing phase

    Time frame: single point assessment in one day during walking with the probe

    time spend not standing on the paretic and non-paretic leg (s) during walking

  10. swing phase

    Time frame: single point assessment in one day during walking without the probe

    time spend not standing on the paretic and non-paretic leg (s) during walking

  11. lower limb kinematics

    Time frame: single point assessment in one day during walking with the probe

    joint angles (°) in the pelvis, hip, knee and ankle in the sagittal, frontal and transverse plane during walking

  12. lower limb kinematics

    Time frame: single point assessment in one day during walking without the probe

    joint angles (°) in the pelvis, hip, knee and ankle in the sagittal, frontal and transverse plane during walking

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Ghent

Registry information

Official study title

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

Acronym: Stroke_DynUS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 9, 2024
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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