Developmental DelayNCT03191006
Effects of Insoles on Children With Developmental Delays
A study testing MEI BIN insoles in people with Developmental Delay, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Using double blind, randomized controlled design to investigate the short-term therapeutic effects of function of customized insoles on children with developmental delays Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Developmental Delay
- 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
- 52 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Jun 2017to 31 Dec 2017
- 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
- No healthy volunteers
- Child
Who may be able to join
- developmental delays
Who cannot join
- age less than 3 years old or older than 10 years old normal development
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Effects of Physical Function and Balance of Customized Insoles on Children With Developmental Delays
Using double blind, randomized controlled design to investigate the short-term therapeutic effects of function of customized insoles on children with developmental delays
Read the detailed description
A total of 52 children with developmental delays will be enrolled. The participants will be randomized into two groups, including study group (with insoles) and control group (without insoles).
The participants in the study group will be evaluated at baseline, that is before the customized insoles are prescribed. All of evaluations, including physical function, balance, and quality of life will be re-evaluated up to 12 weeks after insoles wearing.
The control group will be evaluated at the baseline and up to 12 weeks.
- Conditions
- Developmental Delay
- Being tested
- MEI BIN insoles
- Keywords
- effect, insoles, children
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEI BIN insolesDevice
insoles
| Study group | Role | What they receive |
|---|---|---|
| study group: MEI BIN insoles | Active comparator | Participants in the study group will be prescribed with a pair of customized insoles (MEI BIN) to keep the subtalar joint in neutral position, for 12 weeks. Receives: Device: MEI BIN insoles |
| control group: without MEI BIN insoles | No intervention | Participants in this control group will not receive a pair of customized insoles (MEI BIN) 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 from baseline functional performance (scores) at 12 weeks
Pediatric Outcome Data Collection Instrument
Measured: baseline and up to 12 weeks
Secondary outcomes (3)
change from baseline physical function (time) at 12 weeks
time of stair climbing, timed up and go, walking on level ground
Measured: baseline and up to 12 weeks
change from baseline balance (scores) at 12 weeks
Berg balance scale
Measured: baseline and up to 12 weeks
change from baseline quality of life at 12 weeks
Pediatric Quality of Life inventory (PedsQL)
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 posted19 Jun 2017
- Study start24 Jun 2017 (estimated)
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DelayStudies 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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shin Kong Wu Ho-Su Memorial Hospital
- Responsible party
- Principal investigator, Ru-Lan Hsieh, Taipei Medical University
- Investigators
- Ru-Lan Hsieh, MD, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191006
- Sponsor's protocol ID
- SKH-8302-106-DR-28.
- Status last verified
- Jun 2017
- First submitted
- 11 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 Customized Insoles on Children With Developmental Delays
- ClinicalTrials.gov ID
- NCT03191006
- Acronym / sponsor ID
- SKH-8302-106-DR-28.
- Conditions
- Developmental Delay
- Keywords
- effect, insoles, children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Shin Kong Wu Ho-Su Memorial Hospital
- Study start
- 24 Jun 2017 (estimated)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 19 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 investigate the short-term therapeutic effects of function of customized insoles on children with developmental delays
Detailed description
A total of 52 children with developmental delays will be enrolled. The participants will be randomized into two groups, including study group (with insoles) and control group (without insoles).
The participants in the study group will be evaluated at baseline, that is before the customized insoles are prescribed. All of evaluations, including physical function, balance, and quality of life will be re-evaluated up to 12 weeks after insoles wearing.
The control group will be evaluated at the 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 insolesParticipants in the study group will be prescribed with a pair of customized insoles (MEI BIN) to keep the subtalar joint in neutral position, for 12 weeks. |
| control group: without MEI BIN insoles | No intervention | –Participants in this control group will not receive a pair of customized insoles (MEI BIN) to keep the subtalar joint in neutral position, for 12 weeks. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- developmental delays
Key exclusion criteria (1 listed)
- age less than 3 years old or older than 10 years old normal development
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 insolesinsoles | Device | study group: MEI BIN insoles |
Primary outcome
change from baseline functional performance (scores) at 12 weeks
Time frame: baseline and up to 12 weeks
Pediatric Outcome Data Collection Instrument
3 secondary outcomes
change from baseline physical function (time) at 12 weeks
Time frame: baseline and up to 12 weeks
change from baseline balance (scores) at 12 weeks
Time frame: baseline and up to 12 weeks
change from baseline quality of life at 12 weeks
Time frame: baseline and up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Individual participant dataSharing planned: No
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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, MD principal investigator
Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University
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 Developmental Delay, 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ru-Lan Hsieh, MD (228332211, M001052@ms.skh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline functional performance (scores) at 12 weeks (time frame: baseline and up to 12 weeks). 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.