UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001619 |
|---|---|
| Receipt number | R000001949 |
| Scientific Title | Clinical trial of ReoGo for the rehabilitation of post-stroke hemiplegia - exploratory study |
| Date of disclosure of the study information | 2009/02/01 |
| Last modified on | 2016/04/27 19:23:14 |
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Basic information
Public title
Clinical trial of ReoGo for the rehabilitation of post-stroke hemiplegia - exploratory study
Acronym
Clinical trial of ReoGo for the rehabilitation of post-stroke hemiplegia - exploratory study
Scientific Title
Clinical trial of ReoGo for the rehabilitation of post-stroke hemiplegia - exploratory study
Scientific Title:Acronym
Clinical trial of ReoGo for the rehabilitation of post-stroke hemiplegia - exploratory study
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the efficacy and safety of ReoGo training in patients with post-stroke hemiplegia in upper extremity in addition to a regular rehabilitation intervention, by comparing to those performed self-training program given by PT or OT in addition to a regular rehabilitation intervention.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
(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 secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
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).
Interventions/Control_2
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).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key 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
Key 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
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuhiko Kimura |
Organization
Nihon Rehabilitaion Collage
Division name
President
Zip code
Address
6-18, Takada-3, Toshima-ku TOKYO, Japan
TEL
09033407877
tekimura@nitiriha.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kanatani |
Organization
TEIJIN PHARMA LIMITED
Division name
Home Healthcare Research & Development Department
Zip code
Address
Kasumigaseki Common Gate West Tower 2-1, Kasumigaseki 3-chome,Chiyoda-ku, Tokyo, Japan
TEL
03-3506-4889
Homepage URL
h.kanatani@teijin.co.jp
Sponsor or person
Institute
TEIJIN PHARMA LIMITED
Institute
Department
Personal name
Funding Source
Organization
TEIJIN PHARMA LIMITED
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
時計台記念病院（北海道）
東京湾岸リハビリテーション病院（千葉県）
関西リハビリテーション病院（大阪府）
八幡東病院（福岡県）
白十字病院（福岡県）
長崎北病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://stroke.ahajournals.org/content/47/5/1385.full.html?ijkey=0Q7svyFR0FfHJ9W&keytype=ref
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2008 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 01 | Month | 06 | Day |
Last modified on
| 2016 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001949
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| Registered date | File name |
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| Registered date | File name |
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