HealthyNCT03546218
Effect of Positive-word Stimuli on the Limits of Stability During Multi-direction Reach Operation in Standing Position
A study testing Smartphone Application (SPSRS) and Smartphone Application (YouTube) in people with Healthy, run by Kibi International University at 1 site in Japan.
Trial summary
The purpose of the study was to examine the immediate effect of positive-word stimuli on the limits of stability during multi-direction reach operation in standing position in healthy young adults. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Smartphone Application (SPSRS) and Smartphone Application (YouTube)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteJapan
- Study dates
- 6 Jun 2018to 14 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers between 18 and 24 years of age
- Males and Females
Who cannot join
- Person with physical disability that is enough to interfere with daily life
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effect of Positive-word Stimuli on the Limits of Stability During Multi-direction Reach Operation in Standing Position: A Randomized Controlled Superiority Trial
The purpose of the study was to examine the immediate effect of positive-word stimuli on the limits of stability during multi-direction reach operation in standing position in healthy young adults.
- Conditions
- Healthy
- Being tested
- Smartphone Application (SPSRS), Smartphone Application (YouTube)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone Application (SPSRS)Device
Participants use application on iPhone and watch videos showing positive-word stimuli. This application repeats positive-word stimuli every 5 seconds.
The participants watch 3-minute motion picture displaying positive-word stimuli.
Smartphone Application (YouTube)Device
Participants will watch the same motion picture as the experimental group. However, a positive-word stimulus does not appear in the motion picture.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone Application (SPSRS) | Experimental | Participants watch motion picture using an application that displays positive-word stimuli. Receives: Device: Smartphone Application (SPSRS) |
| Smartphone Application (YouTube) | Active comparator | Participants will watch the same motion picture as the experimental group. However, a positive-word stimulus does not appear in the motion picture. Receives: Device: Smartphone Application (YouTube) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multi-Directional Reach Test
The limits of stability during multi-direction reach operation in standing position
Measured: Baseline and immediately after the intervention protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start6 Jun 2018
- Primary completion14 Jun 2018
- Study completion14 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kibi International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazuki Hirao, PhD, OT, Kibi International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546218
- Sponsor's protocol ID
- 18-16
- Status last verified
- Jul 2018
- First submitted
- 22 May 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Azukizawa K, Hirose K, Morigami Y, Higashi N, Uchida H, Hirao K. Positive-word stimuli via a smartphone application have no immediate-term effects on multi-directional reach ability in standing position: a randomized controlled trial. Ann Med. 2021 Dec;53(1):1402-1409. doi: 10.1080/07853890.2021.1968483.
PubMed 34414832
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Positive-word Stimuli on the Limits of Stability During Multi-direction Reach Operation in Standing Position: A Randomized Controlled Superiority Trial
- ClinicalTrials.gov ID
- NCT03546218
- Acronym / sponsor ID
- 18-16
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Kibi International UniversityUniversity, hospital or other
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 14 Jun 2018 (actual)
- Study completion
- 14 Jun 2018 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study was to examine the immediate effect of positive-word stimuli on the limits of stability during multi-direction reach operation in standing position in healthy young adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone Application (SPSRS) | Experimental | Device: Smartphone Application (SPSRS)Participants watch motion picture using an application that displays positive-word stimuli. |
| Smartphone Application (YouTube) | Active comparator | Device: Smartphone Application (YouTube)Participants will watch the same motion picture as the experimental group. However, a positive-word stimulus does not appear in the motion picture. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteers between 18 and 24 years of age
- Males and Females
Key exclusion criteria (1 listed)
- Person with physical disability that is enough to interfere with daily life
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone Application (SPSRS)Participants use application on iPhone and watch videos showing positive-word stimuli. This application repeats positive-word stimuli every 5 seconds. The participants watch 3-minute motion picture displaying positive-word stimuli. | Device | Smartphone Application (SPSRS) |
| Smartphone Application (YouTube)Participants will watch the same motion picture as the experimental group. However, a positive-word stimulus does not appear in the motion picture. | Device | Smartphone Application (YouTube) |
Primary outcome
Multi-Directional Reach Test
Time frame: Baseline and immediately after the intervention protocol
The limits of stability during multi-direction reach operation in standing position
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Derived from this study: PubMed 34414832Azukizawa K, Hirose K, Morigami Y, Higashi N, Uchida H, Hirao K. Positive-word stimuli via a smartphone application have no immediate-term effects on multi-directional reach ability in standing position: a randomized controlled trial. Ann Med. 2021 Dec;53(1):1402-1409. doi: 10.1080/07853890.2021.1968483.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone Application (SPSRS) and Smartphone Application (YouTube) in people with Healthy, run by Kibi International University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multi-Directional Reach Test (time frame: Baseline and immediately after the intervention protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03546218, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.