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Robot/BTX trial

Clinical trial of robot rehabilitation combined with botulinum treatment in patients with post-stroke spasticity patients - Robot/BTX trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs062180094
Enrollment
60
Registered
2019-03-22
Start date
2017-05-25
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

spasticity stroke spasticity upper limb

Interventions

We will treat the subjects with 240 units of onabotulinumtoxinA (BOTOX) injected into muscles of the affected upper limb using EMG guide. We then perform robotics rehabilitation with Hybrid Assisted
robotics rehabilitation

Sponsors

Fujita Koji
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Those who can understand the significance and the risk of this study Those with upper limb spasticity after stroke with its onset more than 1 year prior to the study Those who have had no relapse of stroke after the initial onset Those who have no apparent decline in cognitive function (HDSR>23) Those who have no apparent deppressive symptoms Those who have no major physical and mental disorders

Exclusion criteria

Exclusion criteria: Those with pregnancy Those with major systemic diseases Those with progressive central nervous system diseases (such as brain tumor) Those with contractures of the elbow joint or with spasticity of modified Ashworth scale being 4

Design outcomes

Primary

MeasureTime frame
changes in active ROM of the elbow joint treated (more than 15 degrees are regarded as significant chang)

Secondary

MeasureTime frame
Fugel-Myer Assessment(FMA), Brunnstrom stage, Visual ,Analogue Scale, changes in sensory impairment (proprioception, kinesthesia)

Contacts

Public ContactKoji Fujita

Tokushima University Hospital

kfujita@tokushima-u.ac.jp+81-88-633-7207

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026