UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025354 |
|---|---|
| Receipt number | R000028934 |
| Scientific Title | Evaluation of rehabilitation intervention using robotics knee orthosis |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2018/06/23 18:39:37 |
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Basic information
Public title
Evaluation of rehabilitation intervention using robotics knee orthosis
Acronym
Evaluation of rehabilitation intervention using RKO
Scientific Title
Evaluation of rehabilitation intervention using robotics knee orthosis
Scientific Title:Acronym
Evaluation of rehabilitation intervention using RKO
Region
| Japan |
Condition
Condition
cerebrovascular disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of RKO for inpatients with cerebrovascular disease, and the safety of RKO and the characteristic of assist setting
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
10m walk fastest time
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
RKO intervention group
Intervention period: 10 days
Interventions/Control_2
rko nonitervention group
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
* Brunnstrom stage: III to IV
* Patinets can keep sitting squqre or standing position by watch or self-support (permission to use a staff)
* Patients can perform assistance walk exercise with therapist
Key exclusion criteria
* Patients cannot use MIE owing to severe aphasia, apraxia, agnosia, dementia, sensory disturbance
* Patients have difficult effort walk owing to hypertension, cardiovascular disease, respiratory disease, severe frailty
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kikuko ikeda |
Organization
Tibatokushuukai hospital of okinawatokushuukai medical Corporation
Division name
Rehabilitation
Zip code
Address
2-11-1 Takasudai Funabashi,Chiba Prefecture,Japan 274-0065
TEL
0474667111
chiken@chibatoku.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | takuya fujita |
Organization
Tibatokushuukai hospital of okinawatokushuukai medical Corporation
Division name
Rehabilitation
Zip code
Address
2-11-1 Takasudai Funabashi,Chiba Prefecture,Japan 274-0065
TEL
0474667111
Homepage URL
chiken@chibatoku.or.jp
Sponsor or person
Institute
Tibatokushuukai hospital of okinawatokushuukai medical Corporation
Institute
Department
Personal name
Funding Source
Organization
Tibatokushuukai hospital of okinawatokushuukai medical Corporation
Organization
Division
Category of Funding Organization
Self funding
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
| 2017 | Year | 01 | Month | 01 | 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
| 2016 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 21 | Day |
Last modified on
| 2018 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028934
