Developmental DisabilitiesNCT02686931
The Investigation of Children With Developmental Delay and Children's Rehabilitation Common Case
An observational study of Developmental Disabilities, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Children with developmental disabilities and children's rehabilitation common case investigation: Long-term follow-up study. Read more about this study
- Who is it for?
- Ages Up to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Disabilities
- How many people
- 2,000 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2013to Jan 2019
- Phase
- Observational
- 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 Up to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Control and experimental groups
Who may be able to join
- Children with aged 0-20 years
- Control group: Children with orthopedic disease, Experimental group: Children with Developmental disabilities
Who cannot join
- Low cooperative with follow-up
- Low cooperative with clinical assessment
- Low cooperative with questionnaire writing and data collection
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 333
Chia-Ling Chen, PhD, +886-3-3281200 ext. 8147, clingchen@gmail.com
About this study
Official title: The Investigation of Children With Developmental Delay and Children's Rehabilitation Common Case: A Longitudinal Study
Children with developmental disabilities and children's rehabilitation common case investigation: Long-term follow-up study.
Read the detailed description
Three fundamental goals of early rehabilitation for children with DD are: optimizing body function within each child's prognostic potential, preventing the development of secondary conditions that impact life-long health, and promoting children's participation in their lives. Knowledge of these developmental patterns of FPLA may be helpful in understanding, anticipating, and managing the problems of these patients. The investigators hypothesize that the course of developmental patterns in Function and Participation in Life Activities (FPLA) of patients with DD evolves with their age. The levels of functional recovery included developmental function, activity, participation, and quality of life (QOL). The aim of this study is to investigate the longitudinal outcomes in patients with DD evaluated by developmental function, activity, participation, and QOL. Additionally, the predictors in the initial stage in determining the final developmental patterns in FPLA of these children will be identified.
- Conditions
- Developmental Disabilities
- Keywords
- Developmental delayed, Orthopedic disease, Longitudinal study
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Control: Normal developmental children with orthopedic disease | |
| Experimental | Experimental: Developmental delayed children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Comprehensive Developmental Inventory for Infants and Toddlers(CDIIT)
Measurement of CDIIT
Measured: baseline, six months and one year
Secondary outcomes (8)
Change of Chinese Child Developmental Inventory (CCDI)
Measurement of CCDI
Measured: baseline, six months and one year
Change of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-II)
Measurement of BOT-II
Measured: baseline, six months and one year
Change of Quality of upper extremity skills test(QUEST)
Measurement of QUEST
Measured: baseline, six months and one year
Change of Peabody Developmental Motor Scales-2nd Edition(PDMS-II)
Measurement of PDMS-II
Measured: baseline, six months and one year
Change of Pediatric Balance Scale(PBS)
Measurement of PBS
Measured: baseline, six months and one year
Change of Gross Motor Function Measure, 66 items,(GMFM-66)
Measurement of GMFM-66
Measured: baseline, six months and one year
Change of Modified Ashworth Scale (MAS)
Measurement of MAS
Measured: baseline, six months and one year
Change of Spinal Alignment and Range of Motion Measure (SAROMM)
Measurement of SAROMM
Measured: baseline, six months and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startJan 2013
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DisabilitiesStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Ling Chen, PhD, Principal investigator, Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686931
- Sponsor's protocol ID
- 102-0474A3
- Status last verified
- Nov 2017
- First submitted
- 25 Feb 2015
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of Children With Developmental Delay and Children's Rehabilitation Common Case: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT02686931
- Acronym / sponsor ID
- 102-0474A3
- Conditions
- Developmental Disabilities
- Keywords
- Developmental delayed, Orthopedic disease, Longitudinal study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 22 Feb 2016 (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.
Children with developmental disabilities and children's rehabilitation common case investigation: Long-term follow-up study.
Detailed description
Three fundamental goals of early rehabilitation for children with DD are: optimizing body function within each child's prognostic potential, preventing the development of secondary conditions that impact life-long health, and promoting children's participation in their lives. Knowledge of these developmental patterns of FPLA may be helpful in understanding, anticipating, and managing the problems of these patients. The investigators hypothesize that the course of developmental patterns in Function and Participation in Life Activities (FPLA) of patients with DD evolves with their age. The levels of functional recovery included developmental function, activity, participation, and quality of life (QOL). The aim of this study is to investigate the longitudinal outcomes in patients with DD evaluated by developmental function, activity, participation, and QOL. Additionally, the predictors in the initial stage in determining the final developmental patterns in FPLA of these children will be identified.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Control: Normal developmental children with orthopedic disease |
| Experimental | – | –Experimental: Developmental delayed children |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Control and experimental groups
Key inclusion criteria (2 listed)
- Children with aged 0-20 years
- Control group: Children with orthopedic disease, Experimental group: Children with Developmental disabilities
Key exclusion criteria (3 listed)
- Low cooperative with follow-up
- Low cooperative with clinical assessment
- Low cooperative with questionnaire writing and data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of Comprehensive Developmental Inventory for Infants and Toddlers(CDIIT)
Time frame: baseline, six months and one year
Measurement of CDIIT
8 secondary outcomes
Change of Chinese Child Developmental Inventory (CCDI)
Time frame: baseline, six months and one year
Change of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-II)
Time frame: baseline, six months and one year
Change of Quality of upper extremity skills test(QUEST)
Time frame: baseline, six months and one year
Change of Peabody Developmental Motor Scales-2nd Edition(PDMS-II)
Time frame: baseline, six months and one year
Change of Pediatric Balance Scale(PBS)
Time frame: baseline, six months and one year
Change of Gross Motor Function Measure, 66 items,(GMFM-66)
Time frame: baseline, six months and one year
Change of Modified Ashworth Scale (MAS)
Time frame: baseline, six months and one year
Change of Spinal Alignment and Range of Motion Measure (SAROMM)
Time frame: baseline, six months and one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- 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.
Chia-Ling Chen, PhD principal investigator
Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Disabilities, run by Chang Gung Memorial Hospital 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 2 inclusion and 3 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 18 Jan 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 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 Chia-Ling Chen, PhD (+886-3-3281200 ext. 8147, clingchen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Comprehensive Developmental Inventory for Infants and Toddlers(CDIIT) (time frame: baseline, six months and one 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 18 Jan 2018; AzTrials last refreshed its copy on 8 Nov 2026.