Robot/BTX trial

JRCT ID: jRCTs062180094

Registered date:22/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: spasticity
• Date of first enrollment: 25/05/2017
• Target sample size: 60
• Study type: Interventional

Intervention(s)

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 Limb (HAL) for 1 hour.
We perform the same session of robotics rehabilitation 1 month (28+-5 days) after the BOTOX injection.
We repeat this cycle of BOTOX injection every 3 moths (84+- 15 days)

Outcome(s)

• Primary Outcome: changes in active ROM of the elbow joint treated (more than 15 degrees are regarded as significant chang)
• Secondary Outcome: Fugel-Myer Assessment(FMA), Brunnstrom stage, Visual ,Analogue Scale, changes in sensory impairment (proprioception, kinesthesia)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 90age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Fujita Koji