Back to resultsEffectiveness of Parents' Manipulation in Newborn With Talipes Calcaneus
Primary Purpose
Talipes Calcaneovalgus
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
manipulation
No intervention
Sponsored by
About this trial
This is an interventional treatment trial for Talipes Calcaneovalgus focused on measuring TCV
Eligibility Criteria
Inclusion Criteria:
- all newborn with talipes calcaneovalgus
Exclusion Criteria:
- patient associated with congenital musculoskeletal anomaly
- patient with other serious medical condition
Sites / Locations
- Faculty of Medicine Siriraj Hospital Mahidol UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
manipulation
observe
Arm Description
home program for parents manipulation
observation
Outcomes
Primary Outcome Measures
percent of success treatment with in six month
Secondary Outcome Measures
duration from start treatment until cure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01767662
Brief Title
Effectiveness of Parents' Manipulation in Newborn With Talipes Calcaneus
Official Title
Natural History and Effectiveness of Parents' Manipulation in Newborn With Talipes Calcaneovalgus,a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Talipes Calcaneovalgus
Keywords
TCV
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
manipulation
Arm Type
Experimental
Arm Description
home program for parents manipulation
Arm Title
observe
Arm Type
Placebo Comparator
Arm Description
observation
Intervention Type
Procedure
Intervention Name(s)
manipulation
Intervention Description
home programme
Intervention Type
Procedure
Intervention Name(s)
No intervention
Intervention Description
observation
Primary Outcome Measure Information:
Title
percent of success treatment with in six month
Time Frame
six month
Secondary Outcome Measure Information:
Title
duration from start treatment until cure
Time Frame
six month
Other Pre-specified Outcome Measures:
Title
failure of treatment
Time Frame
six month
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all newborn with talipes calcaneovalgus
Exclusion Criteria:
patient associated with congenital musculoskeletal anomaly
patient with other serious medical condition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kamolporn kaewpornsawan, MD,Phd
Phone
662 4113191
Email
sikkw@mahidol.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamolporn Kaewpornsawan, MD,Ph.D
Organizational Affiliation
Department of orthopaedic surgery Faculty of medicine siriraj hospital Bangkok Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamolporn kaewpornsawan, M.D, Ph.D
Phone
662 4113191
Email
sikkw@mahidol.ac.th
First Name & Middle Initial & Last Name & Degree
Kamolporn kaewpornsawan, M.D, Ph.D
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Parents' Manipulation in Newborn With Talipes Calcaneus
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