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

Not Applicable

• Conditions: Foot Deformity Congenital
• Interventions: Other: parents manipulation

• Registration Number: NCT02093507
• Lead Sponsor: Mahidol University

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-05
• Status Verified: 2014-03
• Study First Submitted: 2014-03-16
• Study First Submitted QC: 2014-03-20
• Last Update Submitted: 2014-03-20
• Study First Posted: 2014-03-21
• Last Update Posted: 2014-03-21
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• newborn with Metatarsus adducts.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
parents manipulation	parents manipulation	parents manipulation

Primary Outcome Measures

Name	Time	Method
evidence of no foot deformity of newborn	6 month	in the group of parents manipulation or in the group without parents manipulation ,for the period of 6 months the outcomes measurement will be done to assess the evidence of foot deformity remaining by pediatric orthopedic surgeons, the outcomes will be the percentage of success or success rate

Secondary Outcome Measures

Name	Time	Method
the statistical significant difference between sex and duration from disease to cure	6 month	the sex and duration of treatment are the secondary outcomes measurement to evaluate the statistical difference between both groups

Trial Locations

Locations (1)

Siriraj hospoital; 🇹🇭 Bangkoknoi, Bangkok, Thailand