| CTRI Number |
CTRI/2024/09/073500 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Does toe grip strength affect balance in Down syndrome children? |
|
Scientific Title of Study
|
Relationship of toe grip strength and balance in Down Syndrome children and adolescents having flatfeet |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Apoorva Subramony |
| Designation |
PG student |
| Affiliation |
Father Muller College of Physiotherapy |
| Address |
Father Muller College of Physiotherapy
Department of paediatric physiotherapy
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9880465980 |
| Fax |
|
| Email |
arvatell@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Anupama k |
| Designation |
Associate professor |
| Affiliation |
Father Muller College of Physiotherapy |
| Address |
Father Muller College of Physiotherapy
Department of paediatric physiotherapy
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9901324366 |
| Fax |
|
| Email |
anupamakarkera@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Apoorva Subramony |
| Designation |
PG student |
| Affiliation |
Father Muller College of Physiotherapy |
| Address |
Father Muller College of Physiotherapy
Department of paediatric physiotherapy
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9880465980 |
| Fax |
|
| Email |
arvatell@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller College of physiotherapy |
|
|
Primary Sponsor
|
| Name |
Apoorva subramony |
| Address |
Father muller college of physiotherapy
Kankanady
Mangalore
575002 |
| Type of Sponsor |
Other [Self funding] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Apoorva subramony |
St Agnes special school |
Bendoorwell, Mangalore
Dakshina Kannada
KARNATAKA |
9880465980
arvatell@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE (FMIEC) |
Approved |
| FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE (FMIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q909||Down syndrome, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
those with flatfeet (screened using feiss line test), those who can understand simple commands, willing to participate and who can ambulate. |
|
| ExclusionCriteria |
| Details |
those who have walking aids |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the toe grip strength using pinch gauge dynamometer. 3 trials will be done and the best result will be considered |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find the balance using four square step test |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Down syndrome (trisomy 21) is the most common chromosomal disorder which occurs due to the presence of an extra copy of chromosome 21. it is characterized by intellectual disability, short stature, reduced muscle tone, reduced upper and lower limb muscle strength, balance and proprioception problems and foot abnormalities such as the flat feet (pes planus), which occurs as a result of reduced medial longitudinal arch height of the foot. In flat feet, the foot muscles are prone to get weakened over time. Recent studies have pointed out that a decrease in the size and strength of intrinsic foot muscles can affect the persons’ ability to maintain balance. It has been recognized that children and adolescents with Down Syndrome tend to have flatter feet, but so far no study has attempted to find if there is a relationship between toe grip strength and balance in Down Syndrome children and adolescents having flatfeet. |