| CTRI Number |
CTRI/2023/02/049469 [Registered on: 06/02/2023] Trial Registered Prospectively |
| Last Modified On: |
03/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Phasic Proprioceptive Training on Children with Down Syndrome |
|
Scientific Title of Study
|
Effect of Phasic Proprioceptive Training on Dynamic Standing Balance in Children with Down Syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shraddha Chandak |
| Designation |
Master of Neuro Physiotherapy Student |
| Affiliation |
Master of Neuro Physiotherapy Student Maharashtra Institute of Physiotherapy |
| Address |
Maharashtra Institute of Physiotherapy MIMSR Medical Campus
Ambajogai
Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
7798836759 |
| Fax |
|
| Email |
chandak.shraddha98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pallavi Dangat Jadhav |
| Designation |
Professor and HOD of Neuroscience Physiotherapy Department |
| Affiliation |
Maharashtra Institute of Physiotherapy, Latur |
| Address |
Maharashtra Institute of Physiotherapy MIMSR Medical Campus
Ambajogai
Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
9423233617 |
| Fax |
|
| Email |
dr.pallavi.physio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Dangat Jadhav |
| Designation |
Professor and HOD of Neuroscience Physiotherapy Department |
| Affiliation |
Maharashtra Institute of Physiotherapy, Latur |
| Address |
Maharashtra Institute of Physiotherapy MIMSR Medical Campus
Ambajogai
Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
9423233617 |
| Fax |
|
| Email |
dr.pallavi.physio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra Institute of Physiotherapy Latur |
|
|
Primary Sponsor
|
| Name |
Maharashtra Institute of Physiotherapy Latur |
| Address |
Maharashtra Institute of Physiotherapy MIMSR Medical Campus
Ambajogai
Latur |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shraddha Chandak |
NeuroPhysiotherapy OPD, Yeshwantrao Chavan Rural Hospital |
Department of Neurosciences Physiotherapy
Maharashtra Institute of Physiotherapy
MIMSR Medical Campus
Ambajogai
Latur
MAHARASHTRA |
7798836759
chandak.shraddha98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharashtra Institute of Physiotherapy Latur Ethical Committee |
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 |
Proprioception Excercises |
4 weeks 5 session/week 60min/session Stage 1 maintain standing balance, balance on both heels up and down and balance on one leg on stable surface Stage 2 maintain standing balance, balance on both heels up and down and balance on one leg on unstable surface Stage 3 walking on stable surface, standing with feet together and in random stand, squating |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Of both genders from the age of 6-14 years.
With a score of less than 5 in Beighton hypermobility test.
Who are able to understand and follow verbal command in the local language.
Whose parents are willing for them to participate and who themselves are willing. |
|
| ExclusionCriteria |
| Details |
Having any Musculoskeletal deformity/contracture or Cardiac co-morbidity.
Having severe visual or hearing deficits. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Four Square Step Test |
Pre-treatment assessment
Weekly assessment
Post-treatment assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/02/2023 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Permission from the Institutional Ethical Committee will be taken. After screening for Inclusion and Exclusion criteria, informed written consent of the parents of Children with Down Syndrome will be taken. Pre-assessment using Four Square Step Test will be done on Day 1. Children with Down Syndrome will be given 4 weeks of phasic proprioceptive training. Post intervention assessment will be done using Four Square Step Test after every phase as well as after the completion of 4 weeks. Scores of the test will be charted and statistical analysis will be done. Intragroup comparison of study parameter before and after intervention will be done. Results will be obtained. |