Foot Deformity CongenitalNCT02093507
Effectiveness of Parent's Manipulation in Newborn With Metatarsus Adducts. a Randomized Controlled Trial
A study testing parents manipulation in people with Foot Deformity Congenital, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether the result of parent's feet manipulation compared with nonmanipulated group within first 6 months of life and observe spectrum of the disease within this period. Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- Foot Deformity Congenital
- What is being tested?
- parents manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- May 2013to Dec 2014
- 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 1 day to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- newborn with Metatarsus adducts.
Who cannot join
- 1. criteria were included newborns with associated life threatening conditions. 2. congenital or musculoskeletal problems.(ie;arthrogryposis multiplex congenita,skeletal dysplasia) 3. mental retardation. 4. cognitive impairment. 5. parents incooperative. 6. difficult to follow up patients.
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj hospoital
Bangkoknoi, Bangkok, 10700
Kamolporn Kaewpornsawan, MD,PHD, +66224197968 ext. 8307, Kamolporn.Kae@mahidol.ac.th
About this study
Official title: Effectiveness of Parent's Manipulation in Newborn With Metatarsus Adducts.a Randomized Controlled Trial
The purpose of this study is to determine whether the result of parent's feet manipulation compared with nonmanipulated group within first 6 months of life and observe spectrum of the disease within this period.
Read the detailed description
The newborn with metatarsus adducts are included in the study and divide in 2 groups by random.Group A with parents'manipulation of the foot and group B without manipulation of the foot.The parents'foot manipulation is trained by pediatric orthopedic surgeons to correct the deformity.The effectiveness of the manipulation is measured by percentage of no deformity of the foot in newborn after 6 months.
- Conditions
- Foot Deformity Congenital
- Being tested
- parents manipulation
- Keywords
- newborn, foot deformity congenital
- Medical subject headings
- Foot Deformities, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parents manipulationOther
parents perform manipulation the child foot to correct the deformity
| Study group | Role | What they receive |
|---|---|---|
| parents manipulation | Experimental | parents manipulation Receives: Other: parents manipulation |
| no manipulation | No intervention | no manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
evidence of no foot deformity of newborn
in the group of parents manipulation or in the group without parents manipulation ,for the period of 6 months the outcomes measurement will be done to assess the evidence of foot deformity remaining by pediatric orthopedic surgeons, the outcomes will be the percentage of success or success rate
Measured: 6 month
Secondary outcomes (1)
the statistical significant difference between sex and duration from disease to cure
the sex and duration of treatment are the secondary outcomes measurement to evaluate the statistical difference between both groups
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startMay 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Deformity CongenitalStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof.Dr.Kamolporn - Kaewpornsawan, M.D., Principal investigator, Department of orthopaedic surgery,faculty of medicine Siriraj Hospital,Mahidol University,Banfkok,Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093507
- Sponsor's protocol ID
- SI 172/2
- Status last verified
- Mar 2014
- First submitted
- 16 Mar 2014
- Last updated
- 21 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Parent's Manipulation in Newborn With Metatarsus Adducts.a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02093507
- Acronym / sponsor ID
- SI 172/2
- Conditions
- Foot Deformity Congenital
- Keywords
- newborn, foot deformity congenital
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 21 Mar 2014 (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.
The purpose of this study is to determine whether the result of parent's feet manipulation compared with nonmanipulated group within first 6 months of life and observe spectrum of the disease within this period.
Detailed description
The newborn with metatarsus adducts are included in the study and divide in 2 groups by random.Group A with parents'manipulation of the foot and group B without manipulation of the foot.The parents'foot manipulation is trained by pediatric orthopedic surgeons to correct the deformity.The effectiveness of the manipulation is measured by percentage of no deformity of the foot in newborn after 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| parents manipulation | Experimental | Other: parents manipulationparents manipulation |
| no manipulation | No intervention | –no manipulation |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- newborn with Metatarsus adducts.
Key exclusion criteria (1 listed)
- 1. criteria were included newborns with associated life threatening conditions. 2. congenital or musculoskeletal problems.(ie;arthrogryposis multiplex congenita,skeletal dysplasia) 3. mental retardation. 4. cognitive impairment. 5. parents incooperative. 6. difficult to follow up patients.
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 |
|---|---|---|
| parents manipulationparents perform manipulation the child foot to correct the deformity | Other | parents manipulation |
Primary outcome
evidence of no foot deformity of newborn
Time frame: 6 month
in the group of parents manipulation or in the group without parents manipulation ,for the period of 6 months the outcomes measurement will be done to assess the evidence of foot deformity remaining by pediatric orthopedic surgeons, the outcomes will be the percentage of success or success rate
1 secondary outcome
the statistical significant difference between sex and duration from disease to cure
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2014.
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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.
Prof.Dr.Kamolporn - Kaewpornsawan, M.D. principal investigator
Department of orthopaedic surgery,faculty of medicine Siriraj Hospital,Mahidol University,Banfkok,Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing parents manipulation in people with Foot Deformity Congenital, run by Mahidol University at 1 site in Thailand.
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 21 Mar 2014. 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 Thailand. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evidence of no foot deformity of newborn (time frame: 6 month). 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 21 Mar 2014.