A study on improvement of upper limb function by myoelectric response hand movement assist robot for hemiplegia after stroke (REHAROB study)

Not Applicable

• Conditions: Stroke (cerebral infarction or cerebral hemorrhage )

• Registration Number: JPRN-jRCTs032220083
• Lead Sponsor: Matsumoto Syuji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-24
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.Patients who are able to give written consent in person. If the research subject has sufficient capacity to give consent but has difficulty in writing due to disability or other reasons, consent will be obtained by substitute writing after confirming that the subject himself/herself has consented toparticipate in the research.
2. Patients who are between 20 and 80 years of age at the time of consent.
3. Patients in the recovery phase of stroke (within6 months [180 days] of stroke onset).
4. Patients with first-ever stroke, stroke type of cerebral infarction or cerebral hemorrhage (subarachnoid hemorrhage is not eligible), and lesion site ofsupratentorial lesion.
5. Patients who are hospitalized for rehabilitation treatment after stroke.
6. Patients with hand BRS stage I to V on Brunnstrom Recovery Stage (BRS).
7. Patients with stable general condition such as blood pressure, pulse rate, and blood glucose.

Exclusion Criteria

1. Patients with dyspnea on exertion, heart failure,arrhythmia, myocardial infarction, etc., for whom upper limb
functional training is considered difficult.
2. Patients with a history of neurological disease or upper extremity joint disease that affects upper extremity
function.
3. Patients with severe complications such as osteoarthritis of the shoulder and elbow, poorly controlled rheumatoid arthritis, scoliosis, osteoporosis, etc., who have difficulty in upper limb functional training or whose symptoms are judged to worsen with upper limb training.
4. Patients with serious hepatic disorder, renal disorder, or cardiovascular disease.
5. Patients with higher brain dysfunction such as severe sensory impairment, ataxia, and aphasia.
6. Examples of contraindications to upper limbrobotic training.
7. Patients who cannot apply the electrode pad due to skin diseases.
8. Patients who have changed the daily dose of any of the following drugs within the past month from the time of obtaining consent.
- Antispasmodics (tizanidine hydrochloride, eperisone hydrochloride, baclofen, etc.)
9. Patients who, at the time of consent, required other medical treatment that would affect the study due to
fracture, trauma, or other disease.
10. Patients who have received botulinum toxin injection or nerve block with phenol within the past 6 months
from the time of consent.
11. Patients who have undergone robotic upper limb therapy within the past month from the time of
consent.
12. Patients deemed by the physician to be unfit for upper extremity robotic use.
13. Patients who are participating in clinical trials or other clinical research involving interventions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified