| CTRI Number |
CTRI/2018/03/012562 [Registered on: 15/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
20/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Imroving functional recovery in patients with stroke Hemiparesis |
|
Scientific Title of Study
|
Comparative Study Between Dual Task Training And Task Related Training On Functional Recovery In Patients With Stroke: A Double Blind Randomized Controlled Trial |
| Trial Acronym |
DTT-TRT,stroke |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suvarna Ganvir |
| Designation |
Professor |
| Affiliation |
|
| Address |
DVVPFs College of Physiotherapy, Vilad ghat, Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
|
| Fax |
|
| Email |
suvarna.ganvir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suvarna Ganvir |
| Designation |
|
| Affiliation |
|
| Address |
Vilad ghat, Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
|
| Fax |
|
| Email |
suvarna.ganvir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suvarna Ganvir |
| Designation |
|
| Affiliation |
|
| Address |
Vilad ghat, Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
|
| Fax |
|
| Email |
suvarna.ganvir@gmail.com |
|
|
Source of Monetary or Material Support
|
| DVVPFs College of Physiotherapy, Ahmednagar |
|
|
Primary Sponsor
|
| Name |
DVVPFsCollege of Physiotherapy |
| Address |
Vilad ghat |
| 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 |
| Suvarna Ganvir |
DVVPFs College of Physiotherapy |
Vilad ghat, Ahmednagar
Ahmadnagar
MAHARASHTRA |
9372910683
suvarna.jg17@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 |
Stroke, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dual task training |
Includes exercises of lower extremity while performing motor and cognitive tasks with upper extremity |
| Comparator Agent |
Task related training |
Includes lower extremity exercises with a certain task to be accomplished |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with first stroke, cognitively stable, able to carry out basic upper activities |
|
| ExclusionCriteria |
| Details |
Patients with any other neurological or musculoskeletal disorder affecting gait , inability to stand and walk for 10 meters independently |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| POMA scale, balance part |
2 weeks ,4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| dynamic gait index |
2 weeks, 4 weeks, |
| gait parameters |
2weeks,4 weeks |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2017 |
| Date of Study Completion (India) |
20/06/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Suvarna Ganvir, Maheshwari Harishchandre, Chetana Kunde |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
4 weeks of dual task training and 4 weeks of TAsk related training will be given to the two independent groups of patients with first stroke. Outcome measures will be POMA scale , Dynamic gait index and gait parameters. |