| CTRI Number |
CTRI/2013/08/003862 [Registered on: 01/08/2013] Trial Registered Prospectively |
| Last Modified On: |
31/07/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Application of tele physiotherapy in the special school at remote vicinity. |
|
Scientific Title of Study
|
efficacy of telephysiotherapy for rehabilitation of children in special school in remote vicinity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anupamak |
| Designation |
lecturer |
| Affiliation |
Father Muller Medical college |
| Address |
Sri Devi Kripa Souterpeta 5th cross Velencia Managalore
Department of Physiotherapy
Father Muller medical college
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9901324366 |
| Fax |
|
| Email |
anuj2685@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Narasimman S |
| Designation |
Professor and Course Coordinator |
| Affiliation |
Fr Muller Medical College |
| Address |
Father Muller Medical College Kankanady Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
09480265509 |
| Fax |
|
| Email |
naraswamin2001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anupamak |
| Designation |
Lecturer |
| Affiliation |
Father Muller Medical College |
| Address |
Sri devi Kripa Souterpeta 5th cross velencia Mangalore 2
Father Muller Medical college Mangalore 2
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9901324366 |
| Fax |
|
| Email |
anuj2685@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical college and research center |
|
|
Primary Sponsor
|
| Name |
Father Muller Medical college and research centre |
| Address |
Kankanady , Mangalore
575002 |
| 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 |
| Ms Anupamak |
ST Bethany Jeevan Joythi school |
St Bethany Jeevan Joythi School
opp Mardala bus stand , Kadaba , Puttur
Dakshina Kannada
KARNATAKA |
9901324366
anuj2685@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Medical College And research center Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
children with developmental disability like cerebral palsy , downs syndrome , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Physiotherapy via Tele rehabilitation |
Routine physiotherapy will be provided via telecommunication technology
frequency - 3 days per week of tele rehabilitation consultation will be given
therapy duration : 1 hour
study duration : 6 months |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
• Children from special schools
•children with GMFCS level 1- 111
age 3- 18 years
•normal to moderate IQ level
•Children who were identified for the need of physio therapeutic intervention during the disability screening camp in this school.
|
|
| ExclusionCriteria |
| Details |
• Children with GMFCS level IV and V
• Age below 3 years and above 18 years
• Severe mental retardation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Condition specific assessment tools , GMFM , GMFCS, MACS, and FMS
• Individual specific Goal Attainment Scaling
• Service program specific Goal Attainment Scaling
• Quesinnare via Tele interview
|
3 months twice
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| questionnaire via tele rehabilitation |
3 months twice |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
05/08/2013 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
Growing challenge has been observed in the field of Physiotherapy to extend a consistent rehabilitation services for children with disability in remote vicinity .Use of electronic communication to provide health service over large population could be a solution to overcome this challenge. Hence our main aim of this study is to know the feasibility and effectiveness of tele rehabilitation in physiotherapy at special school to establish consistent services .Our secondary aim is to evaluate the extent of leverage of Tele communication in the field of Physiotherapy .This study is a proof of concept experimental study design involving the children from special schools with the convenient sampling . |