UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000001619
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email h.kanatani@teijin.co.jp

Sponsor
Institute TEIJIN PHARMA LIMITED
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001949

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.