| CTRI Number |
CTRI/2024/05/066960 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Which of the two scales TIS or SBS is a better predictor of functional outcome in sub-acute and chronic patients with stroke? |
|
Scientific Title of Study
|
Comparative Study Of Trunk Impairment Scale Vs Sitting Balance Scale As A Predictor Of Functional Outcomes In Patients With Stroke |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sejal M Labhane |
| Designation |
PG Student |
| Affiliation |
DVVPFs College of Physiotherapy |
| Address |
DVVPFs College of Physiotherapy,PDVVPs Foundation Group of Institutions,Off, Manmad Rd, Opp government Milk Dairy, Vilad Ghat, Ahmednagar, Pimpalgaon Malvi, Maharashtra 414111
DVVPFs College of Physiotherapy,PDVVPs Foundation Group of Institutions,Off, Manmad Rd, Opp government Milk Dairy, Vilad Ghat, Ahmednagar, Pimpalgaon Malvi, Maharashtra 414111
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9820303810 |
| Fax |
|
| Email |
dr.sejallabhanept@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suvarna Ganvir |
| Designation |
Head of Department of Neurophysiotherapy |
| Affiliation |
DVVPFs College of Physiotherapy |
| Address |
Department of Neurophysiotherapy, DVVPFs College of Physiotherapy, opposite Govt. Milk Dairy, Vilad Ghat, Ahmadnagar, Maharashtra
DVVPFs College of Physiotherapy,PDVVPs Foundation Group of Institutions,Off, Manmad Rd, Opp government Milk Dairy, Vilad Ghat, Ahmednagar, Pimpalgaon Malvi, Maharashtra 414111
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9372910683 |
| Fax |
|
| Email |
suvarna.ganvir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suvarna Ganvir |
| Designation |
Head of Department of Neurophysiotherapy |
| Affiliation |
DVVPFs College of Physiotherapy |
| Address |
DVVPFs College of Physiotherapy,PDVVPs Foundation Group of Institutions,Off, Manmad Rd, Opp government Milk Dairy, Vilad Ghat, Ahmednagar, Pimpalgaon Malvi, Maharashtra 414111
DVVPFs College of Physiotherapy,PDVVPs Foundation Group of Institutions,Off, Manmad Rd, Opp government Milk Dairy, Vilad Ghat, Ahmednagar, Pimpalgaon Malvi, Maharashtra 414111
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9372910683 |
| Fax |
|
| Email |
suvarna.ganvir@gmail.com |
|
|
Source of Monetary or Material Support
|
| DVVPFs College of Physiotherapy, Vilad Ghat, Ahmednagar 414111 |
|
|
Primary Sponsor
|
| Name |
DVVPFs College of Physiotherapy |
| Address |
PDVVPs Foundation Group of Institutions Off, Manmad Rd, Opp government Milk Dairy, Vilad Ghat, Ahmednagar, Pimpalgaon Malvi, Maharashtra 414111 |
| Type of Sponsor |
Private medical college |
|
|
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 Sejal Milind Labhane |
Vikhe Patil Memorial Hospital Neurophysiotherapy OPD |
Department of Neurophysiotherapy, DVVPFs College of Physiotherapy oppo government Milk Dairy Vilad Ghat Ahmednagar Maharashtra
Ahmadnagar
MAHARASHTRA |
9820303810
dr.sejallabhanept@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DVVPFs Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with 1st ever stroke
Sub-acute and Chronic patients of stroke
Ischemic and Hemorrhagic stroke
Age 30-65 years
Patients with impaired sitting balance
|
|
| ExclusionCriteria |
| Details |
History of other neurological diseases like dementia or peripheral neuropathy
Orthopedic problems
Cardiovascular disease
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Trunk Impairment Scale
Sitting Balance Scale |
Baseline
1 week
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Stroke Impairment Assessment Set
Functional Independence Measure
ICF Codes
Timed Up and Go Test |
Baseline
1 week
4 weeeks |
|
|
Target Sample Size
|
Total Sample Size="39"
Sample Size from India="39"
Final Enrollment numbers achieved (Total)= "39"
Final Enrollment numbers achieved (India)="39" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/05/2024 |
| Date of Study Completion (India) |
15/09/2025 |
| Date of First Enrollment (Global) |
17/05/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
An Observational Analytical Study on patients with Sub-actue and Chronic patients of Stroke using convenience sampling with a sample size of 39 will be conducted to Compare Trunk Impairment Scale and Sitting Balance Scale as a Predictor of Functional Outcomes in Patients with Stroke and collected data will be analyzed by using statistical tests. |