A study of using a robot controlling finger movement and botulinum therapy in patients who suffered from stroke

Phase 1

• Conditions: pper limb spasticity after stroke; post-stroke, spasticity, upper limb, finger joints; spasticity

• Registration Number: JPRN-jRCTs062190016
• Lead Sponsor: Fujita Koji

Brief Summary

The study aimed to conduct a proof-of-concept (POF) trial to maximize the safety of the robot and its add-on effect to botulinum therapy. 4 patients used the robot, but the results were not encouraging. In addition,due to the impact of Covid19, the number of patient visits and rehabilitation time could not be sufficiently secured, and the study was terminated midway.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-24
• Study Completion: 2022-07-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

aged 20-90
more than 1 year after the onset of stroke
without any recurrence of stroke
cognitive function not decreased (HDSR>23)
No signs of depression
No other active diseases affecting other organs or mental disorders

Exclusion Criteria

Pregnancy
Serious systemic diseses
Progressive CNS disorders (e.g brain tumors)
contractures or severe spasticity of finger joint (MAS=4)

Study & Design

• Study Type: Interventional
• Study Design: Not specified