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Effectiveness of Parents' Manipulation in Newborn With Talipes Calcaneus

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ClinicalTrials.gov Identifier: NCT01767662
Recruitment Status : Unknown
Verified January 2013 by Mahidol University.
Recruitment status was:  Recruiting
First Posted : January 14, 2013
Last Update Posted : January 14, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine effectiveness of parents' manipulation in newborn with talipes calcaneovalgus over observation group.

Condition or disease Intervention/treatment
Talipes Calcaneovalgus Procedure: manipulation Procedure: No intervention

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Natural History and Effectiveness of Parents' Manipulation in Newborn With Talipes Calcaneovalgus,a Randomized Controlled Trial
Study Start Date : May 2011
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : August 2013
Arms and Interventions

Arm Intervention/treatment
Experimental: manipulation
home program for parents manipulation
Procedure: manipulation
home programme
Placebo Comparator: observe
observation
Procedure: No intervention
observation


Outcome Measures

Primary Outcome Measures :
  1. percent of success treatment with in six month [ Time Frame: six month ]

Secondary Outcome Measures :
  1. duration from start treatment until cure [ Time Frame: six month ]

Other Outcome Measures:
  1. failure of treatment [ Time Frame: six month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all newborn with talipes calcaneovalgus

Exclusion Criteria:

  • patient associated with congenital musculoskeletal anomaly
  • patient with other serious medical condition
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767662


Contacts
Contact: Kamolporn kaewpornsawan, MD,Phd 662 4113191 sikkw@mahidol.ac.th

Locations
Thailand
Faculty of Medicine Siriraj Hospital Mahidol University Recruiting
Bangkok, Thailand, 10700
Contact: Kamolporn kaewpornsawan, M.D, Ph.D    662 4113191    sikkw@mahidol.ac.th   
Principal Investigator: Kamolporn kaewpornsawan, M.D, Ph.D         
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Kamolporn Kaewpornsawan, MD,Ph.D Department of orthopaedic surgery Faculty of medicine siriraj hospital Bangkok Thailand
More Information

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01767662     History of Changes
Other Study ID Numbers: si319/2011
First Posted: January 14, 2013    Key Record Dates
Last Update Posted: January 14, 2013
Last Verified: January 2013

Keywords provided by Mahidol University:
TCV

Additional relevant MeSH terms:
Talipes
Clubfoot
Equinus Deformity
Flatfoot
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities