StrokeNCT04550793
Using Shear Wave Ultrasound Elastography for Follow up After Anti-spastic Intervention Among Stroke Patients
An observational study of Stroke and Spasticity, Muscle, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke, Spasticity, Muscle, Botulism
- What is being tested?
- Botulinum toxin injection
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2020to Dec 2021
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patient aged above 20 years old with unilateral involvement.
Who may be able to join
- [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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Stroke, Spasticity, Muscle, Botulism, Ultrasound, Activity of Daily Living
- Being tested
- Botulinum toxin injection
- Medical subject headings
- Stroke, Muscle Spasticity, Botulism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin injectionDrug
Botulinum toxin injection at affected brachialis and/or biceps brachials.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | The stroke patients who receive botulinum toxin injection at affected brachialis and/or biceps brachials. Receives: Drug: Botulinum toxin injection | |
| Control | The stroke patients who do not receive botulinum toxin injection at affected brachialis and/or biceps brachials in the past 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shear Wave Ultrasound Elastography
Shear wave ultrasound elastography measurement of spastic upper limb muscles, including biceps brachii and brachialis
Measured: During each follow up visit within 12 weeks time frame
Secondary outcomes (10)
Barthel Index (Wade's version)
Barthel Index assessing activities of daily livings
Measured: 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
Measured: During each follow up visit within 12 weeks time frame
Stroke Rehabilitation Assessment of Movement (STREAM), brief version
STREAM assessing movement condition
Measured: During each follow up visit within 12 weeks time frame
Modified Ashworth Scale (MAS)
MAS scale for assessing spasticity
Measured: During each follow up visit within 12 weeks time frame
Tone Assessment Scale (TAS)
TAS scale for assessing spasticity
Measured: During each follow up visit within 12 weeks time frame
Global improvement scale
Global improvement scale for assessing symptoms related to stroke
Measured: During each follow up visit within 12 weeks time frame
Self-report spasticity symptoms
Self-report spasticity symptoms for assessing spasticity
Measured: During each follow up visit within 12 weeks time frame
EuroQol
EuroQol for evaluating quality of life
Measured: 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
Measured: 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
Measured: During each follow up visit within 12 weeks time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study startSep 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huey-Wen Liang, MD PHD, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550793
- Sponsor's protocol ID
- 202006138RINB
- Status last verified
- Jul 2020
- First submitted
- 9 Sep 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Shear Wave Ultrasound Elastography for Follow up After Anti-spastic Intervention Among Stroke Patients
- ClinicalTrials.gov ID
- NCT04550793
- Acronym / sponsor ID
- 202006138RINB
- Conditions
- Stroke, Spasticity, Muscle, Botulism, Ultrasound, Activity of Daily Living
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Drug: Botulinum toxin injectionThe stroke patients who receive 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patient aged above 20 years old with unilateral involvement.
Key inclusion criteria (7 listed)
- [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]
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin injectionBotulinum toxin injection at affected brachialis and/or biceps brachials. | Drug | Intervention |
Primary outcome
Shear Wave Ultrasound Elastography
Time frame: 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
10 secondary outcomes
Barthel Index (Wade's version)
Time frame: During each follow up visit within 12 weeks time frame
Revised Nottingham Extended Activities of Daily Livings Scale
Time frame: During each follow up visit within 12 weeks time frame
Stroke Rehabilitation Assessment of Movement (STREAM), brief version
Time frame: During each follow up visit within 12 weeks time frame
Modified Ashworth Scale (MAS)
Time frame: During each follow up visit within 12 weeks time frame
Tone Assessment Scale (TAS)
Time frame: During each follow up visit within 12 weeks time frame
Global improvement scale
Time frame: During each follow up visit within 12 weeks time frame
Self-report spasticity symptoms
Time frame: During each follow up visit within 12 weeks time frame
EuroQol
Time frame: During each follow up visit within 12 weeks time frame
Extended Activities of Daily Living
Time frame: During each follow up visit within 12 weeks time frame
Postural Assessment Scale for Stroke Patients (PASS), brief version
Time frame: During each follow up visit within 12 weeks time frame
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huey-Wen Liang, MD PHD study director
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Spasticity, Muscle, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huey-Wen Liang, MD PHD (886-2-23123456 ext. 66697, ntuhpmr.4124@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shear Wave Ultrasound Elastography (time frame: During each follow up visit within 12 weeks time frame). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.