Stroke, Spasticity, Muscle, Botulism, Ultrasound, Activity of Daily Living
Conditions
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.
Interventions
Botulinum toxin injection at affected brachialis and/or biceps brachials.
Sponsors
National Taiwan University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Barthel Index (Wade's version) | During each follow up visit within 12 weeks time frame | Barthel Index assessing activities of daily livings |
| Stroke Rehabilitation Assessment of Movement (STREAM), brief version | During each follow up visit within 12 weeks time frame | STREAM assessing movement condition |
| Tone Assessment Scale (TAS) | During each follow up visit within 12 weeks time frame | TAS scale for assessing spasticity |
| Modified Ashworth Scale (MAS) | During each follow up visit within 12 weeks time frame | MAS scale for assessing spasticity |
| Self-report spasticity symptoms | During each follow up visit within 12 weeks time frame | Self-report spasticity symptoms for assessing spasticity |
| EuroQol | During each follow up visit within 12 weeks time frame | EuroQol for evaluating quality of life |
| 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 |
| 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 |
| Global improvement scale | During each follow up visit within 12 weeks time frame | Global improvement scale for assessing symptoms related to stroke |
Countries
Taiwan
Contacts
Primary ContactHuey-Wen Liang, MD PHD
Outcome results
None listed