FRAT Study

JRCT ID: jRCTs052210163

Registered date:01/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cerebrovascular disease
• Date of first enrollment: 14/03/2022
• Target sample size: 16
• Study type: Interventional
• Intervention(s): Rehabilitation using IVES+ for 20 minutes per day

Outcome(s)

• Primary Outcome: 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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kobayashi Yasuyo
• Secondary Sponsor: OG Wellness
• Source(s) of Monetary Support: Nara Medical University