Effectiveness of Parents' Manipulation in Newborn With Talipes Calcaneus
Sponsor
Mahidol University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01767662
Collaborator
(none)
160
1
2
27
5.9
Study Details
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 | Phase |
|---|---|---|
|
N/A |
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
Anticipated 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 1, 2011
Anticipated Primary Completion Date
:
Jun 1, 2013
Anticipated Study Completion Date
:
Aug 1, 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
- percent of success treatment with in six month [six month]
Secondary Outcome Measures
- duration from start treatment until cure [six month]
Other Outcome Measures
- failure of treatment [six month]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 6 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- all newborn with talipes calcaneovalgus
Exclusion Criteria:
-
patient associated with congenital musculoskeletal anomaly
-
patient with other serious medical condition
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faculty of Medicine Siriraj Hospital Mahidol University | Bangkok | Thailand | 10700 |
Sponsors and Collaborators
- Mahidol University
Investigators
- Principal Investigator: Kamolporn Kaewpornsawan, MD,Ph.D, Department of orthopaedic surgery Faculty of medicine siriraj hospital Bangkok Thailand
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Mahidol University
ClinicalTrials.gov Identifier:
NCT01767662
Other Study ID Numbers:
- si319/2011
First Posted:
Jan 14, 2013
Last Update Posted:
Jan 14, 2013
Last Verified:
Jan 1, 2013
Keywords provided by Mahidol University
Additional relevant MeSH terms: