Effectiveness of Parent's Manipulation in Newborn With Metatarsus Adducts. a Randomized Controlled Trial

NCT ID: NCT02093507

Last Updated: 2014-03-21

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-12-31

Brief Summary

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The purpose of this study is to determine whether the result of parent's feet manipulation compared with nonmanipulated group within first 6 months of life and observe spectrum of the disease within this period.

Detailed Description

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The newborn with metatarsus adducts are included in the study and divide in 2 groups by random.Group A with parents'manipulation of the foot and group B without manipulation of the foot.The parents'foot manipulation is trained by pediatric orthopedic surgeons to correct the deformity.The effectiveness of the manipulation is measured by percentage of no deformity of the foot in newborn after 6 months.

Conditions

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Foot Deformity Congenital

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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parents manipulation

parents manipulation

Group Type EXPERIMENTAL

parents manipulation

Intervention Type OTHER

parents perform manipulation the child foot to correct the deformity

no manipulation

no manipulation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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parents manipulation

parents perform manipulation the child foot to correct the deformity

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* newborn with Metatarsus adducts.

Exclusion Criteria

* 1\. criteria were included newborns with associated life threatening conditions. 2. congenital or musculoskeletal problems.(ie;arthrogryposis multiplex congenita,skeletal dysplasia) 3. mental retardation. 4. cognitive impairment. 5. parents incooperative. 6. difficult to follow up patients.
Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Month

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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Prof.Dr.Kamolporn - Kaewpornsawan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of orthopaedic surgery,faculty of medicine Siriraj Hospital,Mahidol University,Banfkok,Thailand

Locations

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Siriraj hospoital

Bangkoknoi, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Facility Contacts

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Kamolporn Kaewpornsawan, MD,PHD

Role: primary

+66224197968 ext. 8307

Other Identifiers

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SI 172/2

Identifier Type: -

Identifier Source: org_study_id

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