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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02093507
Enrollment
200
Registered
2014-03-21
Start date
2013-05-31
Completion date
2014-12-31
Last updated
2014-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foot Deformity Congenital

Keywords

newborn, foot deformity congenital

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.

Interventions

OTHERparents manipulation

parents perform manipulation the child foot to correct the deformity

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 1 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
evidence of no foot deformity of newborn6 monthin 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

MeasureTime frameDescription
the statistical significant difference between sex and duration from disease to cure6 monththe sex and duration of treatment are the secondary outcomes measurement to evaluate the statistical difference between both groups

Other

MeasureTime frameDescription
the satisfaction score6 monththe satisfaction score of parents to manipulate their children feet

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026