JPRN-jRCTs072180005
Completed
Phase 2
Clinical research for efficacy and safety of hand-finger rehabilitation robot SMOVE in the goods operation training for the patients with upper limb paresis after recovery stage stroke patients: A pilot study under single center, open-label, randomized, standard therapy controlled trial. - SMOVE pilot study_02
Kagiyama Tomoko0 sites16 target enrollmentOctober 25, 2018
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kagiyama Tomoko
- Enrollment
- 16
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
o significant difference in recovery of affected hand / upper limb function due to the difference in intervention between the two groups was revealed. No serious side effects due to SMOVE or malfunction of SMOVE during the intervention were observed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age Between 20 y.o. and 85 y.o.
- •in convalescent stage (15 days to 42 days after onset)
- •with cerebral stroke (cerebral infarction or hemorrhage)
- •being treated with rehabilitation therapy in convalescent stage rehabilitation beds.
- •with hand/finger Brunnstrom stage III to IV
Exclusion Criteria
- •with subarachnoid hemorrhage
- •having upper limb paresis caused not by cerebral stroke.
- •with severe hepatic / renal /cardiac / pulmonary failure
- •with malignant tumor not completely cured
- •whose skin condition is not suitable for electrodes placement, or device putting on their hands.
- •with severe spasticity ( upper than MAS 3\)
- •who are treated with type A botulinus toxin or ITB therapy
Outcomes
Primary Outcomes
Not specified
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