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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000016799 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | stroke | |
Classification by specialty |
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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 |
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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.
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Interventions/Control_3 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Univeristy of Occupational and Environmental Health |
Institute | |
Department |
Funding Source | |
Organization | Ministry of Education, Scinece and Culture |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
Nationality of Funding Organization |
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IRB Contact (For public release) | |
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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 |
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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 | |
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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 |
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Date trial data considered complete |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019373 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |