UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060866 |
|---|---|
| Receipt number | R000069617 |
| Scientific Title | Multimodal characterization of post-stroke spasticity using neurophysiological testing and ultrasound-based muscle assessments: an observational study |
| Date of disclosure of the study information | 2026/03/07 |
| Last modified on | 2026/03/07 10:46:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Understanding post-stroke spasticity using neurophysiological testing and ultrasound-based muscle assessments
Acronym
PSS-MULTI Study
Scientific Title
Multimodal characterization of post-stroke spasticity using neurophysiological testing and ultrasound-based muscle assessments: an observational study
Scientific Title:Acronym
PSS-MULTI Study
Region
| Japan |
Condition
Condition
Stroke (ischemic stroke or intracerebral hemorrhage)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To characterize post-stroke spasticity by examining relationships between clinical spasticity scales, neurophysiological measures, and ultrasound-derived muscle/tissue properties.
Basic objectives2
Others
Basic objectives -Others
An observational study to investigate clinical and physiological determinants of post-stroke spasticity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical spasticity assessments: Modified Ashworth Scale (MAS), Modified Tardieu Scale (MTS)
Neurophysiological assessments: H-reflex and M-wave parameters, reciprocal inhibition (RI), motor evoked potentials (MEPs)
Ultrasound-based muscle and tissue assessments: muscle thickness, echo intensity, fascicle length, pennation angle, muscle perfusion (blood flow), shear-wave velocity (SWV), shear modulus (elastic modulus)
Key secondary outcomes
Physical activity: step count, MET-hours
Clinical assessments: Stroke Impairment Assessment Set (SIAS), Brunnstrom Recovery Stage (BRS), Fugl-Meyer Assessment (FMA), Functional Independence Measure (FIM), Functional Ambulation Categories (FAC), Ankle-Brachial Index (ABI)
Psychophysical measures: visual and auditory reaction times
Motion analysis: optical motion capture
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
First-ever stroke (ischemic stroke or intracerebral hemorrhage)
Age 50-85 years
Key exclusion criteria
Uncontrolled hypertension or hypotension
No motor paresis
History of other central nervous system disorders
History of fracture or peripheral neuropathy in the affected limb
Complete sensory loss in the affected limb
Severe peripheral arterial disease
Severe systemic medical comorbidity
Severe cognitive impairment/higher brain dysfunction or severe psychiatric disorder
History of traumatic brain injury, brain tumor, bilateral hemispheric lesions, cerebellar/brainstem lesions, or subarachnoid hemorrhage (including epilepsy/seizures, hydrocephalus, or surgical clipping)
Chronic headache
Use of medications known to lower the seizure threshold (e.g., tricyclic antidepressants, maprotiline, theophylline, methylphenidate, ketamine, clozapine, zotepine)
Current use of antiseizure medications (antiepileptic drugs)
Recent adjustment of antipsychotics or hypnotics
Alcohol or caffeine abuse, or current withdrawal
Implanted electronic/metal devices incompatible with neurophysiological testing (e.g., pacemaker/ICD, CSF shunt, aneurysm clip)
Use of antispastic medications or botulinum toxin type A injection within the past 3 months
Not approved for participation by the treating physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takatsugu |
| Middle name | |
| Last name | Sato |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Department of Rehabilitation Medicine
Zip code
275-0026
Address
4-1-1 Yatsu, Narashino-shi, Chiba, Japan
TEL
047-453-9000
t.sato1430@gmail.com
Public contact
Name of contact person
| 1st name | Takatsugu |
| Middle name | |
| Last name | Sato |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Department of Rehabilitation Medicine
Zip code
275-0026
Address
4-1-1 Yatsu, Narashino-shi, Chiba, Japan
TEL
047-453-9000
Homepage URL
t.sato1430@gmail.com
Sponsor or person
Institute
Tokyo Bay Rehabilitation Hospital
Institute
Department
Personal name
Takatsugu Sato
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Tokyo Bay Rehabilitation Hospital
Address
4-1-1 Yatsu, Narashino-shi, Chiba, Japan
Tel
047-453-9000
shinsakai@wanreha.net
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2028 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study designed to characterize post-stroke spasticity using clinical spasticity scales, neurophysiological measures, and ultrasound-derived muscle/tissue properties. Associations among these measures will be examined using correlation and multivariable regression analyses. Participants will also be stratified based on clinical features (e.g., severity of motor impairment/spasticity and time since stroke onset), and group differences in the assessment measures will be compared.
Management information
Registered date
| 2026 | Year | 03 | Month | 07 | Day |
Last modified on
| 2026 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069617
