Stroke
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patient with post-stroke hemiplegia 2.Those who are expected to be administered in rehabilitation ward throughout the study phase 3.4-8 weeks post-stroke 4.Brunnstrom Stage III or IV at the time of informed consent
Exclusion criteria
Exclusion criteria: 1.Stoke at brainstem 2.Vision problem 3.Hemorrhagic infarct patient, or subarachnoid hemorrhage patient 4.Problem with sever sensory aphasia 5.Unable to sit still during therapy 6.have significant pain in upper extremity by passive movement 7.Incapable to consent voluntary due to cognitive problem 8.Participated in other clinical study using robotic rehabilitation for upper extremity 9.Received Constrained Induced Movement Therapy for upper extremity 10.Received FES therapy for upper extremity 11.Has heart or respiration problem which could interfere with rehabilitation 12.Has other neuro-muscular disease 13.Weight over 110kg 14.Others when Clinical Trial Coordinator (physician) considered to be unsuitable in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (Outcome Measurements) Baseline, 3 week post, and Post-intervnetion (6 weeks) <Impairment assessment of U/E> 1.Brunnstrom Stage (BS) : U/E 2.Fugl-Meyer (FM) : U/E 3.STEF : All item 4.Motricity Index (MI) : Shoulder and Elbow Flexors 5.Modified Ashworth Scale (MAS) : Elbow flexor and extensor, Spinator, Pronator 6.Wolf Motor Function Test (WMFT) : all 15 items 7.Range of Motion (ROM) : Shoulder, Elbow, Arm, and Wrist <Functional assessment of U/E> 1.Functional Independence Measure (FIM) : all 18 items 2.Motor Activity Log (MAL) : 14 items <Other> 1.Visual Analog Scale (VAS) : Most painful part of U/E (Safety Evaluation) Adverse Event and Intervention Status Report will be collected everyday. Physiological Evaluation will be collected on the same day of outcome measurements. 1.Adverse Event 2.Intervention Status Report 3.Physiological Evaluation | — |
Countries
Japan
Contacts
TEIJIN PHARMA LIMITED Home Healthcare Research & Development Department