Effectiveness of Parents' Manipulation in Newborn With Talipes Calcaneus

January 11, 2013 updated by: Mahidol University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of medicine Siriraj Hospital Mahidol University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all newborn with talipes calcaneovalgus

Exclusion Criteria:

  • patient associated with congenital musculoskeletal anomaly
  • patient with other serious medical condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: manipulation
home program for parents manipulation
Procedure: manipulation
home programme
PLACEBO_COMPARATOR: observe
observation
Procedure: No intervention
observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percent of success treatment with in six month
Time Frame: six month
six month

Secondary Outcome Measures

Outcome Measure
Time Frame
duration from start treatment until cure
Time Frame: six month
six month

Other Outcome Measures

Outcome Measure
Time Frame
failure of treatment
Time Frame: six month
six month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Kamolporn Kaewpornsawan, MD,Ph.D, Department of orthopaedic surgery Faculty of medicine siriraj hospital Bangkok Thailand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ANTICIPATED)

June 1, 2013

Study Completion (ANTICIPATED)

August 1, 2013

Study Registration Dates

First Submitted

January 11, 2013

First Submitted That Met QC Criteria

January 11, 2013

First Posted (ESTIMATE)

January 14, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2013

Last Update Submitted That Met QC Criteria

January 11, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • si319/2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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