UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051511 |
|---|---|
| Receipt number | R000058765 |
| Scientific Title | Study on the amount of physical activity for chronic spinal cord injury |
| Date of disclosure of the study information | 2023/07/04 |
| Last modified on | 2023/07/03 17:10:29 |
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Basic information
Public title
Study on the amount of physical activity for chronic spinal cord injury
Acronym
Study on the amount of physical activity for chronic spinal cord injury
Scientific Title
Study on the amount of physical activity for chronic spinal cord injury
Scientific Title:Acronym
Study on the amount of physical activity for chronic spinal cord injury
Region
| Japan |
Condition
Condition
Spinal cord injury
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between the amount of physical activity and residual functional disability, ADL, and quality of life by measuring the amount of physical activity in people with chronic spinal cord injury and examining how it differs at each neurological level of injury and severity of disease.
Basic objectives2
Others
Basic objectives -Others
To investigate the actual physical activity level of people with chronic spinal cord injury and the effect of physical activity level on residual functional disability, ADL, and QOL.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Physical activity: Activity measurement using smartwatches, questionnaires using survey forms
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
Patient group
(i) Patients who come to the outpatient section of the Department of Orthopaedic Surgery at Keio University Hospital, who have been injured for more than 1 year and 6 months or who have undergone surgery for spinal cord diseases (spinal cord tumors, spinal cord vascular disorders, compression spinal cord disorders, etc.) for more than 1 year and 6 months, and whose functional recovery has reached a plateau.
(ii) Patients who are 18 years of age or older at the time consent is obtained.
(iii) Patients whose consent to participate in this study can be obtained in writing.
Healthy group
(i) Volunteers were recruited by the Department of Orthopaedic Surgery, Keio University School of Medicine, and healthy persons with no history of diseases that may cause autonomic neuropathy who consented to this study.
(ii) Age at least 18 years old at the time consent was obtained.
(iii) Those who have given written consent to participate in this study.
Key exclusion criteria
Patients or healthy volunteers who are identified by the principal investigator or collaborator as being unsuitable to participate in the study.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Nakamura |
Organization
Keio University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 JAPAN
TEL
03-5363-3812
masa@a8.keio.jp
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Sawada |
Organization
Keio University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 JAPAN
TEL
03-5363-3812
Homepage URL
tomonori-sawada@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Masaya Nakamura
Funding Source
Organization
ZENKYOREN (National Mutual Insurance Federation of Agricultural Cooperatives)
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
Institutional Review Board of Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 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
| 2023 | Year | 07 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | 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 examine the relationship between the amount of physical activity and residual functional disability, ADL, and quality of life by measuring the amount of physical activity and examining how it differs at each neurological level of injury and severity of disease in people with chronic spinal cord injury who come to the outpatient section of the Department of Orthopaedic Surgery at Keio University Hospital.
Management information
Registered date
| 2023 | Year | 07 | Month | 03 | Day |
Last modified on
| 2023 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058765
