UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000053053
Receipt number R000060538
Scientific Title The survey on physical activity for health for persons with chronic spinal cord injury
Date of disclosure of the study information 2024/02/01
Last modified on 2025/03/05 10:07:46

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Basic information

Public title

The survey on physical activity for health in persons with chronic spinal cord injury

Acronym

The survey on physical activity for persons with chronic spinal cord injury

Scientific Title

The survey on physical activity for health for persons with chronic spinal cord injury

Scientific Title:Acronym

The survey on physical activity for persons with chronic spinal cord injury

Region

Japan


Condition

Condition

Spinal cord injury

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate the understanding of the physical activity habits and the factors that impede the availability of physical activity of persons with chronic spinal cord injury to promote physical activity tailored to individual needs.

Basic objectives2

Others

Basic objectives -Others

Survey

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

physical activity habits

Key secondary outcomes

Demographics, the information of life, spinal cord injury, secondary health condition, motor function, QOL


Base

Study type

Others,meta-analysis etc


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

Pastly diagnosed with a spinal cord injury by a doctor
Male or female, 18 years of age or older
Agree to participate

Key exclusion criteria

Hospitalized
Dementia or suspected dementia
Congenital diseases (e.g., spina bifida), neurodegenerative diseases (e.g., multiple sclerosis, amyotrophic lateral sclerosis), peripheral neuropathy (e.g., Guillain-Barre syndrome)

Target sample size

2000


Research contact person

Name of lead principal investigator

1st name Masaya
Middle name
Last name Nakamura

Organization

Keio university

Division name

Department of Orthopaedic, School of Medicine

Zip code

1608582

Address

35, Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-5363-3812

Email

masa@a8.keio.jp


Public contact

Name of contact person

1st name Hiroki
Middle name
Last name Okawara

Organization

Keio University

Division name

Department of Orthopaedic, School of Medicine

Zip code

1608582

Address

35, Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-5363-3812

Homepage URL


Email

hiroki.okawara@keio.jp


Sponsor or person

Institute

Keio University

Institute

Department

Personal name



Funding Source

Organization

The Yuumi Memorial Foundation for Home Health Care.

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

the Ethics Committees of Keio University School of Medicine

Address

35, Shinanomachi, Shinjuku-ku, Tokyo, Japan

Tel

03-5363-3879

Email

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

2024 Year 02 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

Enrolling by invitation

Date of protocol fixation

2023 Year 12 Month 12 Day

Date of IRB

2024 Year 02 Month 26 Day

Anticipated trial start date

2024 Year 09 Month 25 Day

Last follow-up date

2025 Year 03 Month 05 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

A survey conducted on persons with chronic spinal cord injury in Japan is performed to determine in detail the actual physical activity and factors related to it.


Management information

Registered date

2023 Year 12 Month 11 Day

Last modified on

2025 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060538