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FRAT Study

Functional Electronic Stimulated Rehabilitation Application for Treatment in patients with cerebrovascular disorders

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052210163
Enrollment
16
Registered
2022-02-01
Start date
2022-03-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular disease Cerebrovascular disease , Rehabilitation

Interventions

Rehabilitation using IVES+ for 20 minutes per day

Sponsors

Kobayashi Yasuyo
Lead Sponsor
OG Wellness
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Within 1 month of cerebrovascular event (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage) 2. With upper limb Brunnstrom stage(BRS)2-4 3. Who are 20 years of age or older at the time of obtaining informed consent 4. Whose consent to participate in this clinical study and the informed consent of the patient have has been obtained in writing

Exclusion criteria

Exclusion criteria: 1. Received treatments, such as botulinum therapy, repeated transcranial magnetic stimulation, transcranial direct current stimulation within 90 days of obtaining consent 2. With a history of surgery(including device therapy)or intravenous t-PA for cerebrovascular event (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage) 3.Cognitive decline(Mini-Mental State Examination(MMSE)is 21 or less) 4.Severe skin symptoms on the affected upper limb 5.Have a history of epileptic seizures 6.With a history of substance abuse or addiction(including alcoholism)at the time of enrollment and within the past year, or patients with complications 7.Using an implantable cardiac stimulator such as a cardiac pacemaker or an implantable assisted heart 8.Using deep brain stimulation 9.With metal(excluding titanium products)implanted in the affected upper limb 10.Who are pregnant or may become pregnant 11.Who are judged by doctors to be inappropriate as research subjects

Design outcomes

Primary

MeasureTime frame
Change in the amount of upper limb Fugl-Meyer Assessment(FMA)with respect to pre-intervention value at week 2 or at the time of discontinuation

Secondary

MeasureTime frame
1.Changes in the amount of Functional Independence Measure(FIM)with respect to pre-intervention value at the 2nd and 4th weeks 2.Changes in the amount of upper limb BRS with respect to pre-intervention value at the 2nd and 4th weeks 3.Changes in the amount of upper limb FMA with respect to pre-intervention value at the 1st, 3rd, and 4th weeks 4.Changes in the amount of Barthel Index(BI)with respect to pre-intervention value at the 2nd and 4th weeks 5.Changes in grip strength with respect to the pre-intervention value at the 1st, 2nd, 3rd, and 4th weeks 6.Changes in the amount of upper limb Manual Muscle Test(MMT)with respect to pre-intervention value at the 1st, 2nd, 3rd, and 4th weeks

Contacts

Public ContactYasuyo Kobayashi

Nara Medical University Hospital

tyasuyo@naramed-u.ac.jp+81-744-22-3051

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026