UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053965 |
|---|---|
| Receipt number | R000061567 |
| Scientific Title | The Effect of Seating Training on Body Temperature Rhythm Improvement in Patients with Impaired Consciousness |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2024/03/25 14:43:46 |
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Basic information
Public title
The Effect of Seating Training on Body Temperature Rhythm Improvement in Patients with Impaired Consciousness
Acronym
The Effect of Seating Training on Body Temperature Rhythm Improvement in Patients with Impaired Consciousness
Scientific Title
The Effect of Seating Training on Body Temperature Rhythm Improvement in Patients with Impaired Consciousness
Scientific Title:Acronym
The Effect of Seating Training on Body Temperature Rhythm Improvement in Patients with Impaired Consciousness
Region
| Japan |
Condition
Condition
Brain injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of intervention on adopting a seated posture on the circadian rhythm assessed by the distal-proximal skin temperature gradient.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The body temperature rhythm as assessed by the distal-proximal skin temperature gradient.
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
| Maneuver |
Interventions/Control_1
Twice daily for five days.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient admitted to the general ward, exhibiting severe chronic consciousness impairment, bedridden, requiring total assistance in activities of daily living.
Key exclusion criteria
Individuals with damage to the hypothalamus, those experiencing fever above 37.5 Celsius due to infection, and those with a BMI of 30 or higher indicating severe obesity.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Nakagawa |
Organization
Osaka university of human sciences
Division name
Faculty of Health Sciences
Zip code
566-0023
Address
1-4-1 Shojaku, Settsu-shi, Osaka
TEL
+81-6-6383-6441
yuki-nakagawa@kun.ohs.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Nakagawa |
Organization
Osaka University of Human Sciences, Japan
Division name
Faculty of Health Sciences
Zip code
566-8501
Address
1-4-1 Shojaku, Settsu-shi, Osaka
TEL
+81-6-6383-6441
Homepage URL
yuki-nakagawa@kun.ohs.ac.jp
Sponsor or person
Institute
Osaka University of Human Sciences
Institute
Department
Personal name
Funding Source
Organization
self-funded
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
A hospital in Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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 | 03 | Month | 31 | 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
6
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The results cannot be published because the paper has not been accepted.
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
| 2020 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 07 | 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
| 2024 | Year | 03 | Month | 25 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061567
