Clinical trial NCT04607486: Investigation of Changes in Lower Limb Muscles After Cerebrovascular Accident
Official title: Reliability Study of a 3D Free-hand Ultrasonography Technique (3DfUS) in Combination With Instrumented Spasticity Assessment (ISA) for the Lower Limb in Chronic First-ever Stroke Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebrovascular Accident
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with first ever chronic stroke:

= First ever stroke subjects with established spasticity and without spasticity will be recruited on the stroke rehabilitation unit and outpatient rehabilitation clinic, University Hospital of Leuven.

Healthy control subjects

= Healthy age-and gender matched subjects will be recruited among healthy university staff of the University Hospital of Leuven, their family and friends.

Brief summary: The aim of this study is to investigate lower limb muscles after cerebrovascular accident

Detailed description: The aim of this study is to define and differentiate the changes in MMT properties related to the alterations in muscle tone of the lower limb in first-ever chronic stroke patients by using a 3D free-hand Ultrasonography (3DfUS) technique in combination with an instrumented spasticity assessment (IPSA). In these chronic stroke patients, the spontaneous neurological recovery is stabilized

Eligibility criteria: Inclusion Criteria:

* Definition of case population :

  o first ever stroke with spasticity of the lower limb.
* Definition of control :

  * first ever stroke without spasticity of the lower limb
  * healthy aged-matched subjects

Exclusion Criteria:

* Musculoskeletal or neurological problems affecting the lower limb
* Presence of other neurological pathology that could lead to spasticity, ataxia, dystonia
* Cognitive problems that impede measurements
* Severe co-morbidities
* Peripheral spastic medication

Primary outcomes:
measure: Muscle volume
timeFrame: 1 day
measure: Muscle and Tendon Length
timeFrame: 1 day
measure: Echogenicity intensity
timeFrame: 1 day
measure: Work [J] derived from the slow stretch
timeFrame: 1 day
measure: Muscle activity EMG [uV] derived from the fast stretch
timeFrame: 1 day
measure: Maximal velocity of performance (Vmax [deg/s])
timeFrame: 1 day
measure: Range of motion [deg] for slow stretch
timeFrame: 1 day
measure: Stiffness [Nm/deg] for slow stretch
timeFrame: 1 day
measure: Joint angle of catch [deg] from the fast stretch
timeFrame: 1 day
measure: Angle of EMG threshold [deg] from the fast stretch
timeFrame: 1 day
measure: Intensity of catch derived from the fast stretch
timeFrame: 1 day
Secondary outcomes:
measure: Clinical assessment of spasticity at fast stretch
timeFrame: 1 day
measure: Clinical assessment of spasticity angle at slow and fast stretch
timeFrame: 1 day
Other outcomes:
measure: Quantify the impairment caused by a stroke
timeFrame: 1 day
measure: Assessments of functional independence in daily life in stroke patients and healthy subjects
timeFrame: 1 day
measure: Assessments of functional status after stroke
timeFrame: 1 day
measure: Assessesment of mobility in stroke patients
timeFrame: 1 day
measure: Assessment of transfer skills in stroke patients and healthy subjects
timeFrame: 1 day
measure: Assessment of the motor impairment in lower limbs of stroke patients
timeFrame: 1 day
measure: Assessments of gait speed analysis in stroke patients and healthy subjects.
timeFrame: Measurement of gait speed in stroke patients and healthy subjects by 5-Meter Walk Test at comfortable or self-selected gait speed.
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Fabienne Schillebeeckx, MD
role: PRINCIPAL_INVESTIGATOR
References: