Robot/BTX trial

Phase 1

• Conditions: spasticity; stroke spasticity upper limb; D009128

• Registration Number: JPRN-jRCTs062180094
• Lead Sponsor: Fujita Koji

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-22
• Study Completion: 2021-03-31
• Results First Posted: 2021-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Fugel-Myer Assessment(FMA), Brunnstrom stage, Visual ,Analogue Scale, changes in sensory impairment (proprioception, kinesthesia)