Development DelayNCT02644317
The Balance Influence of Shoe Inserts on Motor Development Delayed Children
A study testing Modified shoe inserts in people with Development Delay, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
Flatfoot, one of the most common foot problems experienced by preschool-aged children, characterized by the collapse of the foot's medial longitudinal arch. Children with motor developmental delay often have flatfoot, according to clinical observation, and research indicates that preschool age is the main stage of the… Read more about this study
- Who is it for?
- Ages 36 to 83 months
- Conditions the study is for
- Development Delay
- What is being tested?
- Modified shoe inserts
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2015to Dec 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 36 to 83 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preschool aged children with delayed motor development
Who cannot join
- lower limb injury case in six months.
- other neurological history such as cerebral palsy, traumatic brain injury, spina bifida to cause of developmental delay.
- have been or are receiving insoles correction or treatment.
- can not be completed with the instruction by foot measurement and balance measurement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chung Shan Medical University Hospital Institutional Review Board
Flatfoot, one of the most common foot problems experienced by preschool-aged children, characterized by the collapse of the foot's medial longitudinal arch. Children with motor developmental delay often have flatfoot, according to clinical observation, and research indicates that preschool age is the main stage of the medial longitudinal arch development period. There flatfoot symptoms due to poor arch shock effect, poor walking endurance, likely to cause gait problems while growing up. The lack of a stable foot structure to support and maintain posture may lead to delayed motor development. Early training intervention and help to balance stability is the main rehabilitation goal for motor developmental delayed children. With understanding of the foot development of motor development delayed children, proper intervention can be provided to improve the movement and stability of the lower limbs. The possible deformation of the foot structure and resultant pain in the future can also be prevented.
Read the detailed description
The investigators designed a prospective cohort study to long-time follow up of preschool aged children with delayed motor development and to establish standard data, including the foot shape, footprint and balance development. The investigators also discuss the influence of the shoe insert with balance and flatfoot correction. Flatfoot leads to poor gross motor balance and the balance improvement after flatfoot correction has never been studied. The investigators findings should provide direct evidence as a reference for clinical workers.
- Conditions
- Development Delay
- Being tested
- Modified shoe inserts
- Keywords
- Motor development delay, balance, flatfoot, shoe insert
- Medical subject headings
- Learning Disabilities, Psychomotor Disorders, Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified shoe insertsDevice
For experimental arm: wear modified shoe inserts and shoes for balance test.
| Study group | Role | What they receive |
|---|---|---|
| with modified shoe inserts | Experimental | wear the modified shoe inserts and shoes for balance test. Receives: Device: Modified shoe inserts |
| without modified shoe inserts | No intervention | only wear the shoes for balance test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The balance change of Movement ABC-2 scales
balance subscore of Movement ABC-2 scales
Measured: baseline/immediately/12 weeks/1 year/2 year
Secondary outcomes (1)
The change of foot print parameters
foot-print parameters(using CSI scales)
Measured: baseline/12 weeks/1 year/2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development DelayStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GCRC, Chung Shan Medical University
- Investigators
- Kun-Chung Chen, Ph.D., Principal investigator, School of Physical Therapy, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644317
- Sponsor's protocol ID
- CS15103
- Status last verified
- Dec 2015
- First submitted
- 30 Nov 2015
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chung Shan Medical University Hospital Institutional Review Board
- ClinicalTrials.gov ID
- NCT02644317
- Acronym / sponsor ID
- CS15103
- Conditions
- Development Delay
- Keywords
- Motor development delay, balance, flatfoot, shoe insert
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 31 Dec 2015 (estimated)
- 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.
Flatfoot, one of the most common foot problems experienced by preschool-aged children, characterized by the collapse of the foot's medial longitudinal arch. Children with motor developmental delay often have flatfoot, according to clinical observation, and research indicates that preschool age is the main stage of the medial longitudinal arch development period. There flatfoot symptoms due to poor arch shock effect, poor walking endurance, likely to cause gait problems while growing up. The lack of a stable foot structure to support and maintain posture may lead to delayed motor development. Early training intervention and help to balance stability is the main rehabilitation goal for motor developmental delayed children. With understanding of the foot development of motor development delayed children, proper intervention can be provided to improve the movement and stability of the lower limbs. The possible deformation of the foot structure and resultant pain in the future can also be prevented.
Detailed description
The investigators designed a prospective cohort study to long-time follow up of preschool aged children with delayed motor development and to establish standard data, including the foot shape, footprint and balance development. The investigators also discuss the influence of the shoe insert with balance and flatfoot correction. Flatfoot leads to poor gross motor balance and the balance improvement after flatfoot correction has never been studied. The investigators findings should provide direct evidence as a reference for clinical workers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with modified shoe inserts | Experimental | Device: Modified shoe insertswear the modified shoe inserts and shoes for balance test. |
| without modified shoe inserts | No intervention | –only wear the shoes for balance test. |
Who may qualify
- Ages
- 36 to 83 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- preschool aged children with delayed motor development
Key exclusion criteria (4 listed)
- lower limb injury case in six months.
- other neurological history such as cerebral palsy, traumatic brain injury, spina bifida to cause of developmental delay.
- have been or are receiving insoles correction or treatment.
- can not be completed with the instruction by foot measurement and balance measurement.
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 |
|---|---|---|
| Modified shoe insertsFor experimental arm: wear modified shoe inserts and shoes for balance test. | Device | with modified shoe inserts |
Primary outcome
The balance change of Movement ABC-2 scales
Time frame: baseline/immediately/12 weeks/1 year/2 year
balance subscore of Movement ABC-2 scales
1 secondary outcome
The change of foot print parameters
Time frame: baseline/12 weeks/1 year/2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
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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.
Kun-Chung Chen, Ph.D. principal investigator
School of Physical Therapy, Chung Shan 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 Modified shoe inserts in people with Development Delay, run by Chung Shan 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 4 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 31 Dec 2015. 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?
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?
The balance change of Movement ABC-2 scales (time frame: baseline/immediately/12 weeks/1 year/2 year). 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 31 Dec 2015.