UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016799 |
|---|---|
| Receipt number | R000019373 |
| Scientific Title | Clinical study on improvement of upper extremity function in hemiplegic patients in the chronic stage with a simple training-assistance robot |
| Date of disclosure of the study information | 2015/03/15 |
| Last modified on | 2019/03/08 17:07:23 |
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Basic information
Public title
Clinical study on improvement of upper extremity function in hemiplegic patients in the chronic stage with a simple training-assistance robot
Acronym
Clinical study on improvement of the upper extremity function with MA2
Scientific Title
Clinical study on improvement of upper extremity function in hemiplegic patients in the chronic stage with a simple training-assistance robot
Scientific Title:Acronym
Clinical study on improvement of the upper extremity function with MA2
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to reveal whether a simple training-assistance robot improves the upper extremity function in hemiplegic patients in the chronic stage
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer Assessment, Modified Ashworth Scale
Key secondary outcomes
Range of motion, Motor Activity Log, Stroke Impact Scale, Burden of training
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
THe robot group undergoes a 20-minute session of upper extremity training per day, 2 sessions per week, for 12 weeks, 24 sessions in total.
Interventions/Control_2
The control group undergoes a 20-minute session of usual care including group exercises 2 sessions per week, for 12 weeks, 24 sessions in total.
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
| 40 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Stroke hemiplegic patients
2)Six or more than 6 months since the onset
3)Brunnstrom recovery stage for the upper extremity III, IV or V
4)Understand the purpose of this MA2-assisted training
5)Agree to join the study voluntarily
Key exclusion criteria
1)Bilateral hemiplegia
2)Main symptom is ataxia, rigidity or sensory disturbance
3)Severe speech disturbance
4)Dementia
5)Neurological diseases affecting MA2-assisted training except hemiplegia
6)Cardio-respiratory disease affecting MA2-assisted training
7)Musculoskeletal diseases affecting MA2-assisted training
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Hachisuka |
Organization
Moji Medical Center, Kyushu Rosai Hospital, Japn Labour Health and Welfare Organization
Division name
Director Room
Zip code
Address
3-1 Higashiminatomachi, Moji-ku, Kitakyushu
TEL
093-331-3461
khachi@mojih.rofuku.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Ono |
Organization
University of Occupational and Environmental Health
Division name
Department of Rehabilitation Medicine
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu
TEL
093-691-7266
Homepage URL
ono-a@med.uoeh-u.ac.jp
Sponsor or person
Institute
Univeristy of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Scinece and Culture
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 14 | Day |
Last modified on
| 2019 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019373
