UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057453 |
|---|---|
| Receipt number | R000065649 |
| Scientific Title | Health-related quality of Life in patients with Hand and upper extremity disorders after splinting: a longitudinal study of influencing factors using linear mixed-effects model |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/09/29 13:57:58 |
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Basic information
Public title
Health-related quality of Life in patients with Hand and upper extremity disorders after splinting
Acronym
Health-related quality of Life in patients with Hand and upper extremity disorders after splinting
Scientific Title
Health-related quality of Life in patients with Hand and upper extremity disorders after splinting: a longitudinal study of influencing factors using linear mixed-effects model
Scientific Title:Acronym
Health-related quality of Life in patients with Hand and upper extremity disorders after splinting: a longitudinal study of influencing factors using linear mixed-effects model
Region
| Japan |
Condition
Condition
hand and upper extremity disorders
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the temporal changes in health-related quality of life (HRQoL) following splinting in patients with hand surgery conditions. Furthermore, to explore factors influencing the health-related quality of life (HRQoL) of patients with hand surgery conditions who wear splint.
Basic objectives2
Others
Basic objectives -Others
QOL
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SF-8.
Assessments were conducted at three time points: before splinting, one week after splinting and four weeks after splinting.
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
Patients aged 18 years or older with hand and upper extremity disorders for whom splint therapy has been prescribed.
Key exclusion criteria
Patients who cannot independently wear a splint.
Patients with communication difficulties.
Patients prescribed two or more splints.
Patients not followed up for more than 4 weeks.
Patients who did not consent to the research.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Narumi |
Organization
Hirosaki University of Health and Welfare Graduate School
Division name
Graduate School of Community Health Studies
Zip code
036-8102
Address
3-18-1 Sanpinai, Hirosaki, Aomori, Japan
TEL
0172-27-1001
M24005@huhw.onmicrosoft.com
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Narumi |
Organization
Hirosaki University of Health and Welfare Graduate School
Division name
Graduate School of Community Health Studies
Zip code
036-8102
Address
3-18-1 Sanpinai, Hirosaki, Aomori, Japan
TEL
0172-27-0999
Homepage URL
M24005@huhw.onmicrosoft.com
Sponsor or person
Institute
Hirosaki University of Health and Welfare Graduate School
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University of Health and Welfare Graduate School
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
Hirosaki University of Health and Welfare Research Ethics Committee
Address
3-18-1 Sanpinai, Hirosaki, Aomori, Japan
Tel
0172-27-0999
fukuokay@jyoto-gakuen.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 | 04 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
longitudinal stud.
multicentre study.
The recruitment period for participants is planned from the approval of the research ethics committee until October 2025.
The survey items include age, gender, dominant hand, affected side, International Standard Classification of Occupations (ISCO), diagnosis, disease classification, treatment plan, purpose of the splint, site of splint application, material of the splint, appearance of the splint, comfort of the splint, daily splint wearing schedule, total number of wearing days over seven days, years of hand therapy experience of the splint fabricator, and SF-8.
Management information
Registered date
| 2025 | Year | 03 | Month | 31 | Day |
Last modified on
| 2025 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065649
