Normal DevelopmentNCT03198299
Therapeutic Effects of Arch Support Insoles on Children
A study testing MEI BIN insoles in people with Normal Development, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Using double blind, randomized controlled design to study the short-term therapeutic effects of customized arch support insoles on children Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Development
- What is being tested?
- MEI BIN insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2016to 31 Dec 2016
- 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 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children with age 3 to 10 can walk independently for 15 meters can follow up for 12 weeks
Who cannot join
- age less than 3 years or older than 10 years children with developmental delays children with pathological flat feet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Effects of Physical Function and Balance of Arch Support Insoles on Children
Using double blind, randomized controlled design to study the short-term therapeutic effects of customized arch support insoles on children
Read the detailed description
A total of 45 children were enrolled. The children were randomized into two groups, including the study group (insoles group) and the control group (without insoles group).
All participants in the insoles group were evaluated at baseline, that was before the customized arch-support insoles were prescribed. All the evaluations, including functional performance, physical function, and quality of life, were re-evaluated up to 12 weeks after the insoles wearing in the study group (insoles group).
The control group were evaluated at baseline and up to 12 weeks.
- Conditions
- Normal Development
- Being tested
- MEI BIN insoles
- Keywords
- therapeutic effects, insoles, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEI BIN insolesDevice
wearing insoles for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| study group: MEI BIN insoles | Active comparator | Study group: participants in the study group were prescribed with customized insoles (MEI BIN insoles) to keep the subtalar joint in neutral position, for 12 weeks. Receives: Device: MEI BIN insoles |
| control group: without MEI BIN insoles | No intervention | Control group: participants in the control group were not prescribed with customized insoles (MEI BIN insoles) to keep the subtalar joint in neutral position, for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of baseline of level walking time to 12 weeks
time of level walking
Measured: baseline and up to 12 weeks
change of baseline of stairs climbing time to 12 weeks
time of stairs climbing
Measured: baseline and up to 12 weeks
change of baseline of up and go time to 12 weeks
time of up and go
Measured: baseline and up to 12 weeks
change of baseline of chair raising time to 12 weeks
time of chair raising
Measured: baseline and up to 12 week
Secondary outcomes (3)
change of baseline balance (scores) to 12 weeks
Berg balance test
Measured: baseline and up to 12 weeks
change of baseline functional performance(scores) to 12 weeks
Pediatric Outcome Data Collection instrument
Measured: baseline and up to 12 weeks
change of baseline quality of life (scores) to 12 weeks
Child Health Questionnaire-Parent form
Measured: baseline and up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start1 Jan 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal DevelopmentStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ru-Lan Hsieh, Taipei Medical University
- Investigators
- Ru-Lan Hsieh, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198299
- Sponsor's protocol ID
- SKH-8302-105-DR-24
- Status last verified
- Jun 2017
- First submitted
- 13 Jun 2017
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Physical Function and Balance of Arch Support Insoles on Children
- ClinicalTrials.gov ID
- NCT03198299
- Acronym / sponsor ID
- SKH-8302-105-DR-24
- Conditions
- Normal Development
- Keywords
- therapeutic effects, insoles, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 26 Jun 2017 (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.
Using double blind, randomized controlled design to study the short-term therapeutic effects of customized arch support insoles on children
Detailed description
A total of 45 children were enrolled. The children were randomized into two groups, including the study group (insoles group) and the control group (without insoles group).
All participants in the insoles group were evaluated at baseline, that was before the customized arch-support insoles were prescribed. All the evaluations, including functional performance, physical function, and quality of life, were re-evaluated up to 12 weeks after the insoles wearing in the study group (insoles group).
The control group were evaluated at baseline and up to 12 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group: MEI BIN insoles | Active comparator | Device: MEI BIN insolesStudy group: participants in the study group were prescribed with customized insoles (MEI BIN insoles) to keep the subtalar joint in neutral position, for 12 weeks. |
| control group: without MEI BIN insoles | No intervention | –Control group: participants in the control group were not prescribed with customized insoles (MEI BIN insoles) to keep the subtalar joint in neutral position, for 12 weeks. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children with age 3 to 10 can walk independently for 15 meters can follow up for 12 weeks
Key exclusion criteria (1 listed)
- age less than 3 years or older than 10 years children with developmental delays children with pathological flat feet
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 |
|---|---|---|
| MEI BIN insoleswearing insoles for 12 weeks | Device | study group: MEI BIN insoles |
Primary outcome
change of baseline of level walking time to 12 weeks
Time frame: baseline and up to 12 weeks
time of level walking
change of baseline of stairs climbing time to 12 weeks
Time frame: baseline and up to 12 weeks
time of stairs climbing
change of baseline of up and go time to 12 weeks
Time frame: baseline and up to 12 weeks
time of up and go
change of baseline of chair raising time to 12 weeks
Time frame: baseline and up to 12 week
time of chair raising
3 secondary outcomes
change of baseline balance (scores) to 12 weeks
Time frame: baseline and up to 12 weeks
change of baseline functional performance(scores) to 12 weeks
Time frame: baseline and up to 12 weeks
change of baseline quality of life (scores) to 12 weeks
Time frame: baseline and up to 12 weeks
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 26 Jun 2017.
- Individual participant dataSharing planned: No
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.
Ru-Lan Hsieh principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEI BIN insoles in people with Normal Development, run by Taipei Medical University at 1 site in Taiwan.
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 1 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 26 Jun 2017. 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 Taiwan. 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?
change of baseline of level walking time to 12 weeks (time frame: baseline and up to 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2017.