UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058810 |
|---|---|
| Receipt number | R000067251 |
| Scientific Title | A retrospective study to quantify abnormal movements during shoulder elevation in patients with stroke |
| Date of disclosure of the study information | 2025/08/15 |
| Last modified on | 2025/08/15 17:15:38 |
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Basic information
Public title
A retrospective study to quantify abnormal movements during shoulder elevation in patients with stroke
Acronym
Quantitative assessment of abnormal shoulder elevation in stroke
Scientific Title
A retrospective study to quantify abnormal movements during shoulder elevation in patients with stroke
Scientific Title:Acronym
Quantitative assessment of abnormal shoulder elevation in stroke
Region
| Japan |
Condition
Condition
Stroke.
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to quantify abnormal movements in stroke patients using videos during shoulder raising on the paralyzed side.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Angles and coordinates of the shoulder and elbow joints were measured by motion capture of the upper extremity raising movement.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. a history of stroke
2. age 18 years or older
3. a motion analysis of upper limb raising movement (video taken)
Key exclusion criteria
Example of missing data
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Keio University
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Sinjuku-ku, Tokyo
TEL
03-5843-6169
daisuke.ito@keio.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ito |
Organization
Keio University
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Sinjuku-ku, Tokyo
TEL
03-5843-6169
Homepage URL
daisuke.ito@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Daisuke Ito
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University
Address
35 Shinanomachi, Sinjuku-ku, Tokyo
Tel
03-5363-3503
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
| 2025 | Year | 08 | 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
103
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
| 2023 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To collect motion capture of upper limb raising movements that have been used as movement analysis evaluation during intensive upper limb therapy and botulinum therapy, and to calculate a method to calculate the degree of abnormal movements through movement analysis. Furthermore, we will investigate the relationship between the created and calculated quantitative index of abnormal movements and each clinical index (motor paralysis and spasticity).
Management information
Registered date
| 2025 | Year | 08 | Month | 15 | Day |
Last modified on
| 2025 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067251
