Clinical trial of ReoGo for the rehabilitation of post-stroke hemiplegia - exploratory study

UMIN ID: UMIN000001619

Registered date:01/02/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Stroke
• Date of first enrollment: 2009/01/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

6 week intervention (7 days a week). After a regular rehabilitation session for upper extremity by PT or OT (2 credit, 40 minutes), receive a training session using ReoGo (40 minutes).
6 week intervention (7 days a week). After a regular rehabilitation session for upper extremity by PT or OT (2 credit, 40 minutes), perform self-training program following a instruction given by PT or OT (40 minutes).

Outcome(s)

• Primary Outcome: (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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: TEIJIN PHARMA LIMITED
• Source(s) of Monetary Support: TEIJIN PHARMA LIMITED