| CTRI Number |
CTRI/2013/09/004024 [Registered on: 26/09/2013] Trial Registered Prospectively |
| Last Modified On: |
25/11/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Precentage of leg length inequalities among special children |
|
Scientific Title of Study
|
Prevalence of limb length discrepancy among special children – A preliminary prevalence study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1148-3120 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Melini Dsouza |
| Designation |
BPT student |
| Affiliation |
Raghiv Gandhi University of Health Sciences |
| Address |
Alva’s college of Physiotherapy, Moodabidri-574227, Karnataka
32nd Cross Rd, 4th T Block, Jayanagar, Bengaluru, Karnataka 560041
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9620184721 |
| Fax |
|
| Email |
melinidz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ASIR JOHN SAMUEL |
| Designation |
Lecturer |
| Affiliation |
Alva’s college of Physiotherapy |
| Address |
Alva’s college of Physiotherapy, Moodabidri-574227, Karnataka
Alva’s college of Physiotherapy, Moodabidri-574227, Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9481939806 |
| Fax |
|
| Email |
asirjohnsamuel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ASIR JOHN SAMUEL |
| Designation |
Lecturer |
| Affiliation |
Alva’s college of Physiotherapy |
| Address |
Alva’s college of Physiotherapy, Moodabidri-574227, Karnataka
Alva’s college of Physiotherapy, Moodabidri-574227, Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9481939806 |
| Fax |
|
| Email |
asirjohnsamuel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alva’s college of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Chethana Special School |
| Address |
Chethana Special School,
SVT School Road
Karkala, UDUPI DISTRICT , Karnataka 574104 |
| Type of Sponsor |
Other [Special School] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Chetana Child Development Centre |
Balamaruthi Vyayam Mandala, V.T. Road,
Mangalore – 575 001
Karnataka, India
Phone No. – (0824) 2493397 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Asir John Samuel |
Chetana Child Development Centre |
Pediatric Rehabilitation Unit, Balamaruthi Vyayam Mandala, V.T. Road,
Mangalore – 575 001
Karnataka, India
Phone No. – (0824) 2493397
Dakshina Kannada
KARNATAKA |
9481939806
asirjohnsamuel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Alvas Review board on Ethics for Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Children with Downs syndrome, Cerebral palsy, Mental Retardation, Muscular dystrophy, Dystonia, Visual impaired and hearing impaired, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
As it is a Cross-sectional study |
| Comparator Agent |
Not Applicable |
As it is a Cross-sectional study |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1. Children with special needs
2. Able to comprehend and obey the command
3. Cooperative children
|
|
| ExclusionCriteria |
| Details |
1. Any recent injury to lower limb
2. Other injury which prevents from taking the limb length measurments |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| True Limbb Length |
Taken once |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Apparent length |
Taken once. Distance between the umbilicus and the inferior aspect of medial malleolus was recorded as apparent limb length (ALL) |
|
|
Target Sample Size
|
Total Sample Size="103"
Sample Size from India="103"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/10/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="4" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background: Limb length discrepancy (LLD) forms a part of regular musculoskeletal assessment. LLDs contribute to compensatory scoliosis, sacroiliac pain believed due to degenerative changes and increased risk of variety of running injuries. Although, the importance of LLD is much more, the prevalence of LLD in the children with special pediatric population was not established. Objective: To establish the prevalence of lower extremity LLD among the special children in India Method: The special school will be identified by the cluster sampling method for the cross-sectional study. A sample of 103 students, 59 male and 44 female children in special pediatric population, aged 8 to 17 years will be recruited. Their anthropometrics will be measured. Limb length measurements are standardized. After squaring the pelvis, both true and apparent limb length will be measured. The distance between the inferior aspect of ASIS and the inferior aspect of medial malleolus will be noted as true limb length (TLL). Similarly, the distance between the umbilicus and the inferior aspect of medial malleolus will be recorded as apparent limb length (ALL). Difference of 2 cm or more is considered as discrepancy. Descriptive statistics will reported as mean and standard deviation (SD) and prevalence will be reported in proportions. |