REMEDY Study

Phase 3

• Conditions: Patients in stroke recovery phase (within 6 months after stroke onset) Upper limb BRS stage III-V

• Registration Number: JPRN-jRCTs032190179
• Lead Sponsor: Matsumoto Shuji

Brief Summary

The results of this study showed significant pre- and post-intervention improvements in most endpoints in the robot group. However, significant group differences (robot group vs. control group) could not be obtained for most endpoints. We would like to reconsider the number of cases, intervention methods (time per session, frequency, intervention period, etc.), and target settings for future research.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-09
• Study Completion: 2021-08-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1) Patients who can give written consent by themselves. If the subject has sufficient consent ability but writing is difficult due to a disability etc., it is confirmed that the subject agrees to participate in the research, and consent will be obtained by writing.
2) Patients at the age of 20 to 85 at the time of obtaining consent.
3) Patients in stroke recovery phase (within 6 months [180 days] from onset of stroke).
4) Patients who have a first-onset stroke and the type of stroke is cerebral infarction or cerebral hemorrhage (not targeted for subarachnoid hemorrhage).
5) Patients hospitalized for post-stroke rehabilitation treatment.
6) Patients with upper limb BRS stages III to V in Brunnstrom Recovery Stage (BRS).
7) Patients whose general condition such as blood pressure, pulse and blood sugar level is stable.

Exclusion Criteria

1) Patients whose upper limb function training is judged to be difficult due to exertional dyspnea, heart failure, arrhythmia, myocardial infarction, etc.
2) Patients with a history of neurological disorders or upper extremity joint disorders that affect upper extremity function.
3) Patients who have severe advanced disease such as degenerative shoulder and elbow arthropathy, uncontrolled rheumatoid arthritis, scoliosis, and osteoporosis, and it is judged that the upper extremity function training is difficult or their symptoms are exacerbated by upper limb training.
4) Patients with severe liver disorder, kidney disorder, cardiovascular disease (with serious illness, Ministry of Health, Labor and Welfare, Pharmaceutical Affairs Bureau, Safety Division Manager, Notification No. 80, Severity classification criteria for side effects such as drugs ) Judgment based on grade 3 in).
5) Patients with severe brain dysfunction and higher brain dysfunction such as ataxia and aphasia.
6) contraindications of electrical and vibrational stimulation.
Embedded electronic devices (such as pacemakers) users, patients with heart disease, malignancy, tuberculosis, or acute diseases, in extreme weakness, in pregnant women or those who may have pregnancy, perception by atopy etc. Those who may have hypersensitivity, blood flow problems, those who use metal implants, or those who have a history of or suspected epilepsy.
Others, who the doctor deems inappropriate.
In the following cases, it is at the discretion of the doctor.
Blood pressure abnormality, heated person or infection
7) Patients who can not apply the electrode pad due to skin disease etc.
8) Patients who changed the daily dose for the following drugs within the past 1 month from the time of obtaining consent:
Antispasmodic drug (Tizanidine hydrochloride, eperisone hydrochloride, baclofen etc.)
9) Patients who required other treatment to influence the research due to fracture, trauma and other diseases at the time of obtaining consent.
10) Patients who received botulinum toxin injection and phenolic nerve block within the past 6 months from the time of obtaining consent.
11) Patients who received robot treatment for the upper limb within the past 1 month from the time of obtaining consent.
12) A person who is deemed inappropriate by a doctor when participating in this study.
When an appropriate response to electrical stimulation or vibrational stimulation can not be obtained
When it is judged that it is not suitable for continuous use of the forearm pronation robot
When significant improvement in upper limb function is observed
Patients participating in other clinical studies involving trials or interventions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment (FMA)<br>Functional Independence Measure (FIM)

Secondary Outcome Measures

Name	Time	Method
1) Stroke Impairment Assessment Set (SIAS ) <br>2) Motor Activity Log (MAL)<br>3) Active Range of Motion (A-ROM)<br>4) Simple Test for Evaluating hand Function (STEF)<br>5) Number of forearm pronations<br>6) modified Ashworth scale (MAS)<br>7) Medical Research Council (MRC)<br>8) Grip strength<br>9) Questionnaire<br>10) After Effects