Talipes CalcaneovalgusNCT01767662
Effectiveness of Parents' Manipulation in Newborn With Talipes Calcaneus
A study testing manipulation in people with Talipes Calcaneovalgus, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine effectiveness of parents' manipulation in newborn with talipes calcaneovalgus over observation group. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Talipes Calcaneovalgus
- What is being tested?
- manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteThailand
- Study dates
- May 2011to Aug 2013
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- all newborn with talipes calcaneovalgus
Who cannot join
- patient associated with congenital musculoskeletal anomaly
- patient with other serious medical condition
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital Mahidol University
Bangkok, Bangkok, 10700
Kamolporn kaewpornsawan, M.D, Ph.D, 662 4113191, sikkw@mahidol.ac.th
Kamolporn kaewpornsawan, M.D, Ph.D
About this study
Official title: Natural History and Effectiveness of Parents' Manipulation in Newborn With Talipes Calcaneovalgus,a Randomized Controlled Trial
The purpose of this study is to determine effectiveness of parents' manipulation in newborn with talipes calcaneovalgus over observation group.
Read the detailed description
Talipes calcaneovalgus is one of the common foot deformity in newborn. Most of patients can be cure without specific treatment. Manipulation was easy method that parents can preform by their own and may be beneficial in speeding resolution of deformity.
- Conditions
- Talipes Calcaneovalgus
- Being tested
- manipulation, No intervention
- Keywords
- TCV
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manipulationProcedure or surgery
home programme
No interventionProcedure or surgery
observation
| Study group | Role | What they receive |
|---|---|---|
| manipulation | Experimental | home program for parents manipulation Receives: Procedure: manipulation |
| observe | Placebo comparator | observation Receives: Procedure: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent of success treatment with in six month
Measured: six month
Secondary outcomes (1)
duration from start treatment until cure
Measured: six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study startMay 2011
- Primary completionJun 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Talipes CalcaneovalgusStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kamolporn Kaewpornsawan, MD,Ph.D, Principal investigator, Department of orthopaedic surgery Faculty of medicine siriraj hospital Bangkok Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767662
- Sponsor's protocol ID
- si319/2011
- Status last verified
- Jan 2013
- First submitted
- 11 Jan 2013
- Last updated
- 14 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History and Effectiveness of Parents' Manipulation in Newborn With Talipes Calcaneovalgus,a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01767662
- Acronym / sponsor ID
- si319/2011
- Conditions
- Talipes Calcaneovalgus
- Keywords
- TCV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 14 Jan 2013 (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 effectiveness of parents' manipulation in newborn with talipes calcaneovalgus over observation group.
Detailed description
Talipes calcaneovalgus is one of the common foot deformity in newborn. Most of patients can be cure without specific treatment. Manipulation was easy method that parents can preform by their own and may be beneficial in speeding resolution of deformity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| manipulation | Experimental | Procedure: manipulationhome program for parents manipulation |
| observe | Placebo comparator | Procedure: No interventionobservation |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all newborn with talipes calcaneovalgus
Key exclusion criteria (2 listed)
- patient associated with congenital musculoskeletal anomaly
- patient with other serious medical condition
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 |
|---|---|---|
| manipulationhome programme | Procedure or surgery | manipulation |
| No interventionobservation | Procedure or surgery | observe |
Primary outcome
percent of success treatment with in six month
Time frame: six month
1 secondary outcome
duration from start treatment until cure
Time frame: six month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2013.
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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.
Kamolporn Kaewpornsawan, MD,Ph.D principal investigator
Department of orthopaedic surgery Faculty of medicine siriraj hospital Bangkok 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 manipulation in people with Talipes Calcaneovalgus, 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 2 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 14 Jan 2013. 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. Some participants in this study may receive a placebo. 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 Kamolporn kaewpornsawan, MD,Phd (662 4113191, sikkw@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percent of success treatment with in six month (time frame: six 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 14 Jan 2013.