UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049514 |
|---|---|
| Receipt number | R000056333 |
| Scientific Title | The effects of smartphone use in the standing position on the neck, upper and lower limbs, and trunk |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2025/05/20 15:58:24 |
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Basic information
Public title
The effects of smartphone use in the standing position on the neck, upper and lower limbs, and trunk
Acronym
The effects of smartphone use in the standing position on the neck, upper and lower limbs, and trunk
Scientific Title
The effects of smartphone use in the standing position on the neck, upper and lower limbs, and trunk
Scientific Title:Acronym
The effects of smartphone use in the standing position on the neck, upper and lower limbs, and trunk
Region
| Japan |
Condition
Condition
Text neck
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of smartphone use in the standing position on the neck, upper and lower limbs, and trunk. In particular, we will investigate how much the load on the neck increases compared to the normal standing posture.
Basic objectives2
Others
Basic objectives -Others
Investigate whether task changes in smartphone usage affect the load on the neck.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Moments on the neck when using a smartphone in a standing position
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Browse Youtube in a standing position for one minute
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Has had a smartphone for more than six months
2 They use one-handed flicking to input text on their smartphones
3 Target age group is 18-40 years old
Key exclusion criteria
Have musculoskeletal or neurological disorders that prevent safe implementation of standing postures
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Hironori |
| Middle name | |
| Last name | Arii |
Organization
Gunma University Hospital
Division name
Rehabilitation
Zip code
371-8511
Address
3-39-15, Showa machi, Maebashi city, Gunma prefecture
TEL
0272208655
hiro-arii@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Hironori |
| Middle name | |
| Last name | Arii |
Organization
Gunma University Hospital
Division name
Rehabilitation
Zip code
371-8511
Address
3-39-15, Showa machi, Maebashi city, Gunma Prefecture
TEL
0272208655
Homepage URL
hiro-arii@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
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
Gunma University
Address
3-39-15, Showa machi, Maebashi city, Gunma prefecture
Tel
0272208655
hiro-arii@gunma-u.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
| 2022 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000056333
Publication of results
Published
Result
URL related to results and publications
https://journals.sagepub.com/doi/10.1177/10519815241297845?url_ver=Z39.88-2003&rfr_id=ori:rid:crossr
Number of participants that the trial has enrolled
24
Results
The neck flexion angles (mean) were 0.71 for the control, 26.02 for watching, and 30.52 for typing, indicating a significant difference. Significant differences were also observed between the control-watching, control-typing, and watching-typing conditions.
Results date posted
| 2025 | Year | 05 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The subject demographic data (mean) were as follows: the age was 29.9 years old, height was 1.65 m, body weight was 59.5 kg, body mass index (BMI) was 21.7, 22 subjects were right-handed and 2 were left-handed, average daily smartphone usage time was 242.8 min/day, years of smartphone usage was 10.8 years, and SAS-SV was 24.2.
Participant flow
The subjects were recruited by displaying posters in the rehabilitation room of Gunma University Hospital between January and September 2023. The inclusion criteria were as follows: healthy adults 18-40 years old who had been using a smartphone for at least 6 months, typing text with flicking, and daily use of an iPhone. The exclusion criteria were as follows: neck pain, motor and neurological diseases that prevented the safe use of a smartphone in the standing position, visual impairment such that the subjects could not distinguish text displayed on the smartphone even with glasses or other corrective measures, and a history of smoking. Twenty-five subjects were collected, but 1 was excluded because he had a motor disease, leaving finally 12 male and 12 female subjects. Informed consent was obtained from all the subjects.
The participants were asked to provide demographic data, such as age, height, body weight, dominant hand, and years of smartphone usage using a questionnaire. The average daily smartphone usage time was recorded by checking the screen time of the iPhone for the week prior to measurement. In addition, the SAS-SV was
recorded as an evaluation scale for smartphone addiction. Neck flexion angles were measured using a 10-camera Vicon MX at 100 Hz. Markers were fixed to the left and right frontal and occipital regions, spinous processes of C7 and Th8, and left and right acromions. Visual 3D ver.2021.11.3 was used to create head and trunk segments. The neck flexion angle was defined as the angle between the head and trunk segments in the sagittal plane. The same subject was measured for 30 s under each of the 3 conditions (control, watching, and typing), and the median value was used as the representative value. Each condition was randomized. A one-minute break was taken between measurements for each condition.
Adverse events
None
Outcome measures
Neck flexion angles were measured under three measurement conditions: control, watching,typing.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2022 | Year | 11 | Month | 15 | Day |
Last modified on
| 2025 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056333
