Dynamic Ultrasound of the Calf Muscles After Stroke (Stroke_DynUS)

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Gait Disorders, Neurologic
• Intervention / Treatment: Diagnostic test: Dynamic ultrasound of the calf muscles

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy controls	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
Experimental: Stroke patient	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
gait speed	walking velocity (m/s)	single point assessment in one day during walking with the probe
gait speed	walking velocity (m/s)	single point assessment in one day during walking without the probe
step width	step width (m)	single point assessment in one day during walking with the probe
step width	step width (m)	single point assessment in one day during walking without the probe
Step length	Step length (m) of the paretic and non paretic side	single point assessment in one day during walking with the probe
Step length	Step length (m) of the paretic and non paretic side	single point assessment in one day during walking without the probe
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Actual): April 4, 2024
• Study Completion (Actual): April 4, 2024

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID Numbers: ONZ-2023-0497; B6702023000632 (Registry Identifier: Belgium register)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No