| CTRI Number |
CTRI/2023/01/049048 [Registered on: 17/01/2023] Trial Registered Prospectively |
| Last Modified On: |
24/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Factors affecting recovery in Stroke patients upto 6 months |
|
Scientific Title of Study
|
Factors affecting functional recovery in patients with Stroke upto 6 months – A Longitudinal Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubhangi Mukund |
| Designation |
1st MPT, Neurophysiotherapy |
| Affiliation |
Dr. Vitthalrao Vikhe Patil Foundation College of Physiotherapy |
| Address |
Department of Neurophysiotherapy, Basement DVVPFs, College of Physiotherapy, Ahmednagar- 414111
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
7218619631 |
| Fax |
|
| Email |
shubhangimukund97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suvarna Ganvir |
| Designation |
HOD and Professor |
| Affiliation |
Dr. Vitthalrao Vikhe Patil Foundation College of Physiotherapy |
| Address |
Department of Neurophysiotherapy, Basement DVVPFs, College of Physiotherapy, Ahmednagar- 414111 Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9372910683 |
| Fax |
|
| Email |
suvarna.ganvir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suvarna Ganvir |
| Designation |
HOD and Professor |
| Affiliation |
Dr. Vitthalrao Vikhe Patil Foundation College of Physiotherapy |
| Address |
Department of Neurophysiotherapy, DVVPFs, College of Physiotherapy, Ahmednagar- 414111 Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9372910683 |
| Fax |
|
| Email |
suvarna.ganvir@gmail.com |
|
|
Source of Monetary or Material Support
|
| DVVPFs College of Physiotherapy, opp. govt Milk dairy, MIDC, Ahmednagar- 414111 |
|
|
Primary Sponsor
|
| Name |
DVVPFs College of Physiotherapy |
| Address |
College of Physiotherapy, opp. govt Milk dairy, MIDC, Ahmednagar- 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 |
| Shubhangi Mukund |
DVVPFs College of Physiotherapy |
Department of Neurophysiotherapy, Opp. govt Milk dairy, MIDC, Ahmednagar- 414111
Ahmadnagar
MAHARASHTRA |
7218619631
shubhangimukund97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DVVPFs Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients with acute stroke
Patients willing to participate
|
|
| ExclusionCriteria |
| Details |
Any diagnosed upper & lower limb fracture,
Any recent surgery of Upper & lower limb,
Neurological problems other than stroke,
Patients with cardiovascular disorders.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Stroke Rehabilitation Assessment of Movements
2.Rivermead Mobility Index
3.Brunnstorm Recovery Stages
4.National Institute of Health Stroke Scale |
0-8 Days, 1 Month, 3 Months, 6 Months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2023 |
| 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="1"
Months="5"
Days="0" |
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)?
Response - NO
|
|
Brief Summary
|
This study is to identify the factors affecting functional recovery in
patients with Stroke upto 6 months. Participant will be assessed with the help of scales like STREAM, RMI , NIHSS to measure the functional recovery and the clinical recovery will be assessed by using Brunnstorm Recovery Stage at different time points like, at baseline 0-8 days, 1 Months, 3 months and 6 months. |