Effectiveness of Parents' Manipulation in Newborn With Ta... | NCT01767662

Studies
Effectiveness of Parents' Manipulation in Newborn With Talipes Calcaneus

NCT01767662

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

Jan 14, 2013Estimated

Enrollment

160Estimated

Phase

Not Applicable

Conditions

Talipes Calcaneovalgus

Interventions

manipulation
No intervention

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Jun 2013Estimated

Completion Date

Aug 2013Estimated

First Submitted Date

Jan 11, 2013

First Submission Date that Met QC Criteria

Jan 11, 2013

First Posted Date

Jan 14, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2013

Last Update Posted Date

Jan 14, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
manipulation	Experimental	home program for parents manipulation	Procedure: manipulation
observe	Placebo Comparator	observation	Procedure: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
manipulation	Procedure	home programme	manipulation
No intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
percent of success treatment with in six month		six month

Secondary Outcomes

Measure	Description	Time Frame
duration from start treatment until cure		six month

Other Outcomes

Measure	Description	Time Frame
failure of treatment		six month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all newborn with talipes calcaneovalgus

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kamolporn kaewpornsawan, MD,Phd	Contact	662 4113191		sikkw@mahidol.ac.th

Overall Officials

Name	Affiliation	Role
Kamolporn Kaewpornsawan, MD,Ph.D	Department of orthopaedic surgery Faculty of medicine siriraj hospital Bangkok Thailand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine Siriraj Hospital Mahidol University	Recruiting	Bangkok	Bangkok	10700	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D005413	Flatfoot

Ancestor Terms

ID	Term
D000070558	Talipes
D005531	Foot Deformities, Acquired
D005530	Foot Deformities
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided