UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061601 |
|---|---|
| Receipt number | R000070481 |
| Scientific Title | Improvement and Evaluation of a Self-Assistive Device for One-Handed Hair Tying |
| Date of disclosure of the study information | 2026/05/17 |
| Last modified on | 2026/05/17 13:17:18 |
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Basic information
Public title
Study to Evaluate an Improved Assistive Device for One-Handed Hair Tying
Acronym
One-Handed Hair-Tying Device Study
Scientific Title
Improvement and Evaluation of a Self-Assistive Device for One-Handed Hair Tying
Scientific Title:Acronym
OHHT Device Improvement Study
Region
| Japan |
Condition
Condition
Upper limb functional impairment
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To improve an assistive device for one-handed hair tying and evaluate whether it improves task time and operability compared with the device used in the previous study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total task time for hair tying
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants will perform a one-handed hair-tying task using both the device from the previous study and the improved device. After receiving instructions and performing practice trials for each device, participants will complete the formal trials. For each trial, the total task time required to complete hair tying, the time for each procedural step, and the success rate will be recorded, and subjective evaluations will also be collected. The intervention period is one day, and each participant will perform trials with both devices on the same day. The order of device use will be adjusted as necessary.
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
Female
Key inclusion criteria
Healthy adults aged 18 years or older
Individuals affiliated with Hokkaido University of Science
Individuals able to participate in the one-handed hair-tying task
Individuals with no difficulty in wearing a wig and using the assistive devices
Individuals who have understood the purpose and procedures of this study and have provided written informed consent
Key exclusion criteria
Individuals with infectious diseases requiring systemic treatment
Individuals with a body temperature of 37.0 C or higher at the time of enrollment
Individuals with trauma, pain, inflammation, or other symptoms in the head, neck, or upper limbs that may interfere with the experimental task
Individuals who may experience discomfort or skin problems due to wearing a wig
Individuals judged to have difficulty in sufficiently understanding the study procedures and providing consent on their own free will
Individuals judged by the principal investigator to be inappropriate for study participation
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Tsuruga |
Organization
Hokkaido University of Science
Division name
Department of Prosthetics and Orthotics, Faculty of Health Sciences
Zip code
006-8585
Address
7-Jo 15-4-1 Maeda, Teine, Sapporo, Hokkaido, Japan
TEL
011-688-2235
tsuruga@hus.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Tsuruga |
Organization
Hokkaido University of Science
Division name
Department of Prosthetics and Orthotics, Faculty of Health Sciences
Zip code
006-8585
Address
7-Jo 15-4-1 Maeda, Teine, Sapporo, Hokkaido, Japan
TEL
011-688-2235
Homepage URL
tsuruga@hus.ac.jp
Sponsor or person
Institute
Hokkaido University of Science
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University of Science
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
Hokkaido University of Science Ethics Committee
Address
7-Jo 15-4-1 Maeda, Teine, Sapporo, Hokkaido, Japan
Tel
011-688-2241
kenkyu@hus.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
| 2026 | Year | 05 | Month | 17 | 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
10
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 07 | Month | 06 | Day |
Date analysis concluded
| 2026 | Year | 07 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 17 | Day |
Last modified on
| 2026 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070481
