NCT01767662

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

January 14, 2013

Status Verified

January 1, 2013

Enrollment Period

2.1 years

First QC Date

January 11, 2013

Last Update Submit

January 11, 2013

Conditions

Talipes Calcaneovalgus

Keywords

TCV

Outcome Measures

Primary Outcomes (1)

  • percent of success treatment with in six month

    six month

Secondary Outcomes (1)

  • duration from start treatment until cure

    six month

Other Outcomes (1)

  • failure of treatment

    six month

Study Arms (2)

manipulation

EXPERIMENTAL

home program for parents manipulation

Procedure: manipulation

observe

PLACEBO COMPARATOR

observation

Procedure: No intervention

Interventions

manipulationPROCEDURE

home programme

manipulation
No interventionPROCEDURE

observation

observe

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • all newborn with talipes calcaneovalgus

You may not qualify if:

  • patient associated with congenital musculoskeletal anomaly
  • patient with other serious medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital Mahidol University

Bangkok, Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Kamolporn Kaewpornsawan, MD,Ph.D

    Department of orthopaedic surgery Faculty of medicine siriraj hospital Bangkok Thailand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kamolporn kaewpornsawan, MD,Phd

CONTACT

662 4113191sikkw@mahidol.ac.th

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2013

First Posted

January 14, 2013

Study Start

May 1, 2011

Primary Completion

June 1, 2013

Study Completion

August 1, 2013

Last Updated

January 14, 2013

Record last verified: 2013-01

Locations

TH(1)