Effectiveness of Parents' Manipulation in Newborn With Talipes Calcaneus

NCT ID: NCT01767662

Last Updated: 2013-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Talipes Calcaneovalgus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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manipulation

home program for parents manipulation

Group Type EXPERIMENTAL

manipulation

Intervention Type PROCEDURE

home programme

observe

observation

Group Type PLACEBO_COMPARATOR

No intervention

Intervention Type PROCEDURE

observation

Interventions

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manipulation

home programme

Intervention Type PROCEDURE

No intervention

observation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* all newborn with talipes calcaneovalgus

Exclusion Criteria

* patient associated with congenital musculoskeletal anomaly
* patient with other serious medical condition
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kamolporn Kaewpornsawan, MD,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of orthopaedic surgery Faculty of medicine siriraj hospital Bangkok Thailand

Locations

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Faculty of Medicine Siriraj Hospital Mahidol University

Bangkok, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Kamolporn kaewpornsawan, MD,Phd

Role: CONTACT

662 4113191

Facility Contacts

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Kamolporn kaewpornsawan, M.D, Ph.D

Role: primary

662 4113191

Other Identifiers

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si319/2011

Identifier Type: -

Identifier Source: org_study_id

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