Using Shear Wave Ultrasound Elastography for Follow up After Anti-spastic Intervention Among Stroke Patients

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04550793
Collaborator
(none)
100
1
15
6.7

Study Details

Study Description

Brief Summary

Spasticity of stroke patient, a very common complication in clinical practice, affects performance of hand function and gait pattern. It also interferes with quality of life of patients severely. Currently first line clinical approach to spasticity consist of physical therapy and pharmacological management. However, there are still some refractory cases that needed local intervention such as Botox injection.

So far, we only can use subjective methods to measure muscle tension, such as modified Ashworth scale and Tone Assessment Scale. In our previous study, we found that ultrasound shear wave image could correlate with muscle stiffness caused by poststroke spasticity. With this new method, we aim to establish a more objective method in measuring abnormal poststroke muscle tension before and after treatments and further monitor therapeutic effect. We also include several assessment scales to evaluate the correlation between measured muscle spasm and activity of daily living.

We hypothesize that the rheological changes in muscles muscle spasm after Botox injection can be detected by ultrasound shear wave image. Therapeutic effect can also be seen in its effect on daily functions.

In this project, we will use shear wave imaging of ultrasound to investigate the elasticity (and hardness) of the biceps brachii and brachialis muscle in stroke patients with unilateral hemiplegia before and after Botox injection. The findings of this project will provide the objective evaluation of muscle spasticity and its correlation with functional status, which will provide new points of view toward treatment of spasticity.

Condition or Disease Intervention/Treatment Phase
  • Drug: Botulinum toxin injection

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Using Shear Wave Ultrasound Elastography for Follow up After Anti-spastic Intervention Among Stroke Patients
Anticipated Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Intervention

The stroke patients who receive botulinum toxin injection at affected brachialis and/or biceps brachials.

Drug: Botulinum toxin injection
Botulinum toxin injection at affected brachialis and/or biceps brachials.

Control

The stroke patients who do not receive botulinum toxin injection at affected brachialis and/or biceps brachials in the past 3 months.

Outcome Measures

Primary Outcome Measures

  1. Shear Wave Ultrasound Elastography [During each follow up visit within 12 weeks time frame]

    Shear wave ultrasound elastography measurement of spastic upper limb muscles, including biceps brachii and brachialis

Secondary Outcome Measures

  1. Barthel Index (Wade's version) [During each follow up visit within 12 weeks time frame]

    Barthel Index assessing activities of daily livings

  2. Revised Nottingham Extended Activities of Daily Livings Scale [During each follow up visit within 12 weeks time frame]

    Revised Nottingham Extended Scale assessing activities of daily livings

  3. Stroke Rehabilitation Assessment of Movement (STREAM), brief version [During each follow up visit within 12 weeks time frame]

    STREAM assessing movement condition

  4. Modified Ashworth Scale (MAS) [During each follow up visit within 12 weeks time frame]

    MAS scale for assessing spasticity

  5. Tone Assessment Scale (TAS) [During each follow up visit within 12 weeks time frame]

    TAS scale for assessing spasticity

  6. Global improvement scale [During each follow up visit within 12 weeks time frame]

    Global improvement scale for assessing symptoms related to stroke

  7. Self-report spasticity symptoms [During each follow up visit within 12 weeks time frame]

    Self-report spasticity symptoms for assessing spasticity

  8. EuroQol [During each follow up visit within 12 weeks time frame]

    EuroQol for evaluating quality of life

  9. Extended Activities of Daily Living [During each follow up visit within 12 weeks time frame]

    Extended Activities of Daily Living scale for evaluating activity of daily living

  10. Postural Assessment Scale for Stroke Patients (PASS), brief version [During each follow up visit within 12 weeks time frame]

    PASS for evaluating symptoms related to stroke

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

[Intervention group]

  • Stroke patients with unilateral involvement

  • Patient's spasticity over affected upper extremities scored at least 1+ with Modified Ashworth Scale

  • Patient required botulinum toxin injection at affected upper limb muscle per primary care physician.

[Control group]

  • Stroke patients with unilateral involvement

  • Patient's spasticity over affected upper extremities scored at least 1+ with Modified Ashworth Scale

Exclusion Criteria:
  • Patients ever diagnosed with cerebral diseases other than stroke, such as traumatic brain injury, encephalitis and brain tumor

  • Patients failed to cooperated due to cognition, consciousness or speech problem

  • Patients with illness that could affect muscle stiffness, such as spinal cord injury and Parkinson's disease

  • Patients with upper limb contracture

  • Patients receiving botulinum toxin injection or shock wave therapy over upper extremities during past three months

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Taiwan 100

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

  • Study Director: Huey-Wen Liang, MD PHD, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT04550793
Other Study ID Numbers:
  • 202006138RINB
First Posted:
Sep 16, 2020
Last Update Posted:
Sep 16, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2020