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Clinical Trials/JPRN-jRCTs062190016
JPRN-jRCTs062190016
Completed
Phase 1

A Study of Meltin Robot Hand Rehabilitation after Botulinum Therapy in Post-stroke Spasticity - MeltinRobot/BTX

Fujita Koji0 sites4 target enrollmentSeptember 24, 2019
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Conditionspper limb spasticity after strokepost-stroke, spasticity, upper limb, finger jointsspasticity

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
pper limb spasticity after stroke
Sponsor
Fujita Koji
Enrollment
4
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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.

Registry
who.int
Start Date
September 24, 2019
End Date
July 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Fujita Koji

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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