Effectiveness of Parents' Manipulation in Newborn With Talipes Calcaneus

Talipes Calcaneovalgus Clinical Trial

Official title:

Natural History and Effectiveness of Parents' Manipulation in Newborn With Talipes Calcaneovalgus,a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01767662
• Other study ID #: si319/2011
• Status: Recruiting
• Phase: N/A
• First received: January 11, 2013
• Last updated: January 11, 2013
• Start date: May 2011
• Est. completion date: August 2013

Study information

• Verified date: January 2013
• Source: Mahidol University
• Contact: Kamolporn kaewpornsawan, MD,Phd
• Phone: 662 4113191
• Email: sikkw[@]mahidol.ac.th
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• all newborn with talipes calcaneovalgus

Exclusion Criteria:

• patient associated with congenital musculoskeletal anomaly

• patient with other serious medical condition

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clubfoot
• Equinus Deformity
• Talipes Calcaneovalgus

Intervention

Procedure:
• manipulation
home programme
• No intervention
observation

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	failure of treatment		six month	Yes
Primary	percent of success treatment with in six month		six month	Yes
Secondary	duration from start treatment until cure		six month	Yes