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

Fujita Koji0 sites15 target enrollmentMarch 22, 2019

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Fujita Koji
Enrollment: 15
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

We have studied the effect of a robot (HAL) designed for assisting in those patients who had BoNT injections for more than 12 months were measured for active ROM before and after the use of HAL for 40 minutes. In conclusion, the present study demonstrated immediate effects of improving active ROM of the elbow joint in patients with decreased spasticity due to stroke who had had BoNT injection for more than 1 year. Its long-term effects were promising in further ameliorating the active function of the limb.

Registry

who.int

Start Date

March 22, 2019

End Date

March 31, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Fujita Koji

Eligibility 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

•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