FRAT Study

Phase 2

Recruiting

• Conditions: Cerebrovascular disease; Cerebrovascular disease , Rehabilitation

• Registration Number: JPRN-jRCTs052210163
• Lead Sponsor: Kobayashi Yasuyo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 16

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified