Effectiveness of Parents' Manipulation in Newborn With Talipes Calcaneus

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Mahidol University
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01767662
First received: January 11, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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


Condition Intervention
Talipes Calcaneovalgus
Procedure: manipulation
Procedure: No intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Natural History and Effectiveness of Parents' Manipulation in Newborn With Talipes Calcaneovalgus,a Randomized Controlled Trial

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • percent of success treatment with in six month [ Time Frame: six month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • duration from start treatment until cure [ Time Frame: six month ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • failure of treatment [ Time Frame: six month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: May 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: manipulation
home program for parents manipulation
Procedure: manipulation
home programme
Placebo Comparator: observe
observation
Procedure: No intervention
observation

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.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01767662     History of Changes
Other Study ID Numbers: si319/2011
Study First Received: January 11, 2013
Last Updated: January 11, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
TCV

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

ClinicalTrials.gov processed this record on July 31, 2014