Back to resultsEffectiveness of Parent's Manipulation in Newborn With Metatarsus Adducts. a Randomized Controlled Trial
Primary Purpose
Foot Deformity Congenital
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
parents manipulation
Sponsored by
About this trial
This is an interventional treatment trial for Foot Deformity Congenital focused on measuring newborn, foot deformity congenital
Eligibility Criteria
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.
Sites / Locations
- Siriraj hospoitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
parents manipulation
no manipulation
Arm Description
parents manipulation
no manipulation
Outcomes
Primary Outcome Measures
evidence of no foot deformity of newborn
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
the statistical significant difference between sex and duration from disease to cure
the sex and duration of treatment are the secondary outcomes measurement to evaluate the statistical difference between both groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02093507
Brief Title
Effectiveness of Parent's Manipulation in Newborn With Metatarsus Adducts. a Randomized Controlled Trial
Official Title
Effectiveness of Parent's Manipulation in Newborn With Metatarsus Adducts.a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Deformity Congenital
Keywords
newborn, foot deformity congenital
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
parents manipulation
Arm Type
Experimental
Arm Description
parents manipulation
Arm Title
no manipulation
Arm Type
No Intervention
Arm Description
no manipulation
Intervention Type
Other
Intervention Name(s)
parents manipulation
Intervention Description
parents perform manipulation the child foot to correct the deformity
Primary Outcome Measure Information:
Title
evidence of no foot deformity of newborn
Description
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
Time Frame
6 month
Secondary Outcome Measure Information:
Title
the statistical significant difference between sex and duration from disease to cure
Description
the sex and duration of treatment are the secondary outcomes measurement to evaluate the statistical difference between both groups
Time Frame
6 month
Other Pre-specified Outcome Measures:
Title
the satisfaction score
Description
the satisfaction score of parents to manipulate their children feet
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof.Dr.Kamolporn - Kaewpornsawan, M.D.
Organizational Affiliation
Department of orthopaedic surgery,faculty of medicine Siriraj Hospital,Mahidol University,Banfkok,Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj hospoital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamolporn Kaewpornsawan, MD,PHD
Phone
+66224197968
Ext
8307
Email
Kamolporn.Kae@mahidol.ac.th
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Parent's Manipulation in Newborn With Metatarsus Adducts. a Randomized Controlled Trial
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