An observational study in Stroke, Spasticity, Muscle and Botulism, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-09-16.
Sponsored by National Taiwan University Hospital · Observational
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 100 is below the median of 152 across 1,968 observational studies indexed under Stroke.
Browse Stroke studies →National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Stroke patient aged above 20 years old with unilateral involvement.
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[Intervention group]
[Control group]
Exclusion Criteria:
The stroke patients who receive botulinum toxin injection at affected brachialis and/or biceps brachials.
Drug: Botulinum toxin injection
The stroke patients who do not receive botulinum toxin injection at affected brachialis and/or biceps brachials in the past 3 months.
Botulinum toxin injection at affected brachialis and/or biceps brachials.
Shear Wave Ultrasound Elastography
Shear wave ultrasound elastography measurement of spastic upper limb muscles, including biceps brachii and brachialis
Time frame: During each follow up visit within 12 weeks time frame
Barthel Index (Wade's version)
Barthel Index assessing activities of daily livings
Time frame: During each follow up visit within 12 weeks time frame
Revised Nottingham Extended Activities of Daily Livings Scale
Revised Nottingham Extended Scale assessing activities of daily livings
Time frame: During each follow up visit within 12 weeks time frame
Stroke Rehabilitation Assessment of Movement (STREAM), brief version
STREAM assessing movement condition
Time frame: During each follow up visit within 12 weeks time frame
Modified Ashworth Scale (MAS)
MAS scale for assessing spasticity
Time frame: During each follow up visit within 12 weeks time frame
Tone Assessment Scale (TAS)
TAS scale for assessing spasticity
Time frame: During each follow up visit within 12 weeks time frame
Global improvement scale
Global improvement scale for assessing symptoms related to stroke
Time frame: During each follow up visit within 12 weeks time frame
Self-report spasticity symptoms
Self-report spasticity symptoms for assessing spasticity
Time frame: During each follow up visit within 12 weeks time frame
EuroQol
EuroQol for evaluating quality of life
Time frame: During each follow up visit within 12 weeks time frame
Extended Activities of Daily Living
Extended Activities of Daily Living scale for evaluating activity of daily living
Time frame: During each follow up visit within 12 weeks time frame
Postural Assessment Scale for Stroke Patients (PASS), brief version
PASS for evaluating symptoms related to stroke
Time frame: During each follow up visit within 12 weeks time frame
Plan to share: No
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This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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