UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035682 |
|---|---|
| Receipt number | R000040621 |
| Scientific Title | Transition of a severely hemiparetic upper limb to a supporting upper limb home-based occupational therapy |
| Date of disclosure of the study information | 2019/01/26 |
| Last modified on | 2019/01/26 17:33:20 |
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Basic information
Public title
Transition of a severely hemiparetic upper limb to a supporting upper limb
home-based occupational therapy
Acronym
Development of a purposeful activity electrical stimulation therapy rehabilitation programme
Scientific Title
Transition of a severely hemiparetic upper limb to a supporting upper limb
home-based occupational therapy
Scientific Title:Acronym
Development of a purposeful activity electrical stimulation therapy rehabilitation programme
Region
| Japan |
Condition
Condition
Subjects are cerebral stroke patients with severe hemiparesis.
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is attempt to combine the use of purposeful activity (PA) and Functional Electrical Stimulation (EST) to retrain the upper limb with severe hemiparesis due to cerebral stroke for use as a supportive upper limb.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effectiveness of purposeful activity and electrical stimulation therapy is evaluated using FuglMeyer Assessment (FMA).
The programme was planned to last for approximately 7 months. Three months was divided into two phases, with a 1-month break period between the two.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
This study is attempte to combine the use of PA and EST to retrain the upper limb with severe hemiparesis due to cerebral stroke for use as a supportive upper limb. PA is a concept that is intrinsic to recreation and work and comprises activities based on an individual's interests. This method was termed as PA EST, which stimulates the disused severely hemiparetic upper limb and trains it so that it can be used in activities of daily living, with the belief that this can enrich the stroke survivor's daily experiences.
Interventions/Control_2
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
| 50 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects is cerebral stroke patients with severe hemiparesis and aged 50 - 70 years. Inclusion criteria is as follows: 6 months since stroke onset, scores of 50 points on the FMA of motor function, ability to maintain a seated position and having cognitive functions to enable daily conversation.
Key exclusion criteria
The subjects excluded were those who can not conduct daily conversation.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seigo Minami |
Organization
Osaka Kawasaki Rehabilitation University, Japan
Division name
Faculty of Rehabilitation
Zip code
Address
158, Mizuma, Kaizuka, Osaka, Japan 567-0104
TEL
0724466700
seigo.minami@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seigo Minami |
Organization
Osaka Kawasaki Rehabilitation University, Japan
Division name
Faculty of Rehabilitation
Zip code
Address
158, Mizuma, Kaizuka, Osaka, Japan 567-0104
TEL
0724466700
Homepage URL
seigo.minami@gmail.com
Sponsor or person
Institute
Osaka Kawasaki Rehabilitation University, Japan
Institute
Department
Personal name
Funding Source
Organization
The France Bed Medical Home Care Research Subsidy Public Interest Incorporated Foundations
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2019 | Year | 01 | Month | 26 | 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
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | 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
| 2019 | Year | 01 | Month | 26 | Day |
Last modified on
| 2019 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040621
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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