Understanding post-stroke spasticity using neurophysiological testing and ultrasound-based muscle assessments

Multimodal characterization of post-stroke spasticity using neurophysiological testing and ultrasound-based muscle assessments: an observational study - PSS-MULTI Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060866

Enrollment

Registered

2026-03-07

Start date

2026-03-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke (ischemic stroke or intracerebral hemorrhage)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: First-ever stroke (ischemic stroke or intracerebral hemorrhage) Age 50-85 years

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactTakatsugu Sato

Tokyo Bay Rehabilitation Hospital Department of Rehabilitation Medicine

t.sato1430@gmail.com047-453-9000

Outcome results