UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037892 |
|---|---|
| Receipt number | R000043196 |
| Scientific Title | Examination about effect of functional improvement by partial assist exercise for stroke patients with hemiplegia |
| Date of disclosure of the study information | 2019/09/03 |
| Last modified on | 2025/02/19 22:11:49 |
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Basic information
Public title
Examination about effect of functional improvement by partial assist exercise for stroke patients with hemiplegia
Acronym
Examination about effect of functional improvement by partial assist exercise for stroke patients with hemiplegia
Scientific Title
Examination about effect of functional improvement by partial assist exercise for stroke patients with hemiplegia
Scientific Title:Acronym
Examination about effect of functional improvement by partial assist exercise for stroke patients with hemiplegia
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the characteristics of muscle activity and investigate the rehabilitation effect when performing partial assistance exercise during elevation of upper limb in stroke patients with hemiplegia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electromyography of surround shoulder (Upper trapezius, pectoralis major, anterior deltoid, middle deltoid, posterior deltoid, biceps, triceps)
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In stroke patients with hemiplegia, rehabilitation of partial assistance exercise by exoskelton robot is performed for 40 minutes a day for 10 days. The muscle activity, joint angle, and joint torque of the proximal upper limb muscles are measured during the intervention.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) hemiparesis after stroke
2) first-ever stroke
3) ROM of shoulder flexion is more than 90 degrees
4) the score of SIAS is 2 or more
5) no cognitive deficit
Key exclusion criteria
Severe heart disease;
Severe hypertension;
Acute fever;
Severe renal failure;
Severe liver disease;
Severe orthopedic disease;
History of major psychiatric or previous
neurological diseases, including seizures;
Spontaneous pain, inflammation, or impingement on the shoulder joint;
Disturbance of consciousness;
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Keio university School of Medicine
Division name
Drepartment of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL
03-5363-3833
michiyukikawakami@hotmail.com
Public contact
Name of contact person
| 1st name | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Keio university School of Medicine
Division name
Drepartment of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL
03-5363-3833
Homepage URL
michiyukikawakami@hotmail.com
Sponsor or person
Institute
Department of Rehabilitation Medicine, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
National Institute of Information and Communications Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University Hospital Clinical Translational Research Center
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
Tel
03-5363-3879
med-rinri-jimu@adst.keio.ac.jp
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 | 09 | Month | 03 | 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
| 2019 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 02 | Day |
Last modified on
| 2025 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043196
