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Completed

NCT Number: NCT04607486

Investigation of Changes in Lower Limb Muscles After Cerebrovascular Accident

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

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Key information

Conditions

Cerebrovascular Accident Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, 3000, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

3DfUS and IPSA of leg muscles

Diagnostic Test
  • 3DfUS technique enhances a conventional 2D US device into a platform capable of reconstructing 3D anatomical data sets.
  • IPSA for quantification of hyper-resistance and its underlying components. The sensors in the IPSa include gyroscopes and accelerometers to measure joint angle and angular velocity, EMG to measure muscle activity, and a 3 degrees-of freedom force sensor to measure torque applied on the joint.
  • clinical functional capacity = clinical evaluation of degree of independence, mobility and gait

Other names: clinical functional capacity

Primary outcomes

  1. Muscle volume

    Time frame: 1 day

    Estimation of muscle volume by 3D freehand ultrasonography.

  2. Muscle and Tendon Length

    Time frame: 1 day

    Estimation of muscle volume by 3D freehand ultrasonography

  3. Echogenicity intensity

    Time frame: 1 day

    Estimation of echogenicity intensity by 3D freehand ultrasonography on an 8-bit greyscale (256 values).

  4. Work [J] derived from the slow stretch

    Time frame: 1 day

    Measurement of Work [J] by Instrumented Spasticity Assessment

  5. Muscle activity EMG [uV] derived from the fast stretch

    Time frame: 1 day

    Measurement of Muscle activity EMG [uV] by Instrumented Spasticity Assessment

  6. Maximal velocity of performance (Vmax [deg/s])

    Time frame: 1 day

    Measurement of Maximal velocity of performance (Vmax [deg/s]) by Instrumented Spasticity Assessment

  7. Range of motion [deg] for slow stretch

    Time frame: 1 day

    Measurement of Range of motion [deg] by Instrumented Spasticity Assessment

  8. Stiffness [Nm/deg] for slow stretch

    Time frame: 1 day

    Measurement of Stiffness [Nm/deg] by Instrumented Spasticity Assessment

  9. Joint angle of catch [deg] from the fast stretch

    Time frame: 1 day

    Measurement of Joint angle of catch [deg] from the fast stretch by Instrumented Spasticity Assessment

  10. Angle of EMG threshold [deg] from the fast stretch

    Time frame: 1 day

    Measurement of Angle of EMG threshold [deg] by Instrumented Spasticity Assessment

  11. Intensity of catch derived from the fast stretch

    Time frame: 1 day

    Measurement of Intensity of catch by Instrumented Spasticity Assessment

Secondary outcomes

  1. Clinical assessment of spasticity at fast stretch

    Time frame: 1 day

    Estimation of spasticity by Modified Assessment Scale

  2. Clinical assessment of spasticity angle at slow and fast stretch

    Time frame: 1 day

    Estimation of spasticity by Tardieu Scale

Other outcomes

  1. Quantify the impairment caused by a stroke

    Time frame: 1 day

    Evaluation of impairment caused by stroke by National Institute Health Stroke Scale

  2. Assessments of functional independence in daily life in stroke patients and healthy subjects

    Time frame: 1 day

    Evaluation of functional independence in daily life is assessed by the Barthel Index

  3. Assessments of functional status after stroke

    Time frame: 1 day

    Evaluation of functional status after stroke is assessed by the Functional Independence Measure

  4. Assessesment of mobility in stroke patients

    Time frame: 1 day

    Evaluation of mobility after stroke is assessed by the Rivermead Mobility Index

  5. Assessment of transfer skills in stroke patients and healthy subjects

    Time frame: 1 day

    Measurement of functional lower extremity strength and/or identify movement strategies in stroke patients and healthy subjects by The Five Times Sit to Stand Test

  6. Assessment of the motor impairment in lower limbs of stroke patients

    Time frame: 1 day

    Measurement of lower limb strength in stroke patients by the Motricity Index

  7. Assessments of gait speed analysis in stroke patients and healthy subjects.

    Time frame: Measurement of gait speed in stroke patients and healthy subjects by 5-Meter Walk Test at comfortable or self-selected gait speed.

    1 day

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Oct 29, 2020
Registry last updated
May 8, 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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