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

M

Mahidol University

Status

Unknown

Conditions

Foot Deformity Congenital

Treatments

Other: parents manipulation

Study type

Interventional

Funder types

Other

Identifiers

NCT02093507
SI 172/2

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

1 day to 1 month old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

parents manipulation
Experimental group
Description:
parents manipulation
Treatment:
Other: parents manipulation
no manipulation
No Intervention group
Description:
no manipulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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