NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs062180094

Registered date:22/03/2019

Robot/BTX trial

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedspasticity
Date of first enrollment25/05/2017
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
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 Outcomechanges in active ROM of the elbow joint treated (more than 15 degrees are regarded as significant chang)
Secondary OutcomeFugel-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
GenderBoth
Include criteriaThose 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 criteriaThose 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

Contact

Public contact
Name Koji Fujita
Address Kuramotocho 3-18-15, Tokushima City Tokushima Japan 770-8503
Telephone +81-88-633-7207
E-mail kfujita@tokushima-u.ac.jp
Affiliation Tokushima University Hospital
Scientific contact
Name Koji Fujita
Address Kuramotocho 3-18-15, Tokushima City Tokushima Japan 770-8503
Telephone +81-88-633-7207
E-mail kfujita@tokushima-u.ac.jp
Affiliation Tokushima University Hospital