| CTRI Number |
CTRI/2024/01/061793 [Registered on: 24/01/2024] Trial Registered Prospectively |
| Last Modified On: |
22/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Improving Gait and Balance of Stroke Patients |
|
Scientific Title of Study
|
Motor versus Cognitive Dual Task Training to improve Gait and Balance of Stroke patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vanshika Arora |
| Designation |
PG Student |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Room No-11, Lower Ground Floor, Amity Institute of Health Allied Sciences,Amity University, Sector-125, Noida, Uttar Pradesh
India Physio Clinic, Room No-1, Ground Floor, E-72, Sector-3, Greater Noida, Pin Code- 201310
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
8285157647 |
| Fax |
|
| Email |
28011999v@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Meena Gupta |
| Designation |
Assistant Professor-II |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
faculty Room, Lower Ground, Block-F1, Amity institute of Health and Allied Sciences, Amity University Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9717281491 |
| Fax |
|
| Email |
mgupta9@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Vanshika Arora |
| Designation |
PG Student |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Room No-11, Lower Ground Floor, Amity Institute of Health Allied Sciences,Amity University, Sector-125, Noida, Uttar Pradesh
India Physio Clinic, Room No-1, Ground Floor, E-72, Sector-3, Greater Noida, Pin Code- 201310
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
8285157647 |
| Fax |
|
| Email |
28011999v@gmail.com |
|
|
Source of Monetary or Material Support
|
| India Physio Clinic, Greater Noida |
|
|
Primary Sponsor
|
| Name |
Vanshika Arora |
| Address |
Amity institute of Health and Allied sciences, Amity University, Sector-125, Noida, Uttar Pradesh |
| Type of Sponsor |
Other [self] |
|
|
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 Kapil Chaudhary |
India Physio Clinic |
OPD, Room no-1, Ground Floor, E-72 Sector 36 Greater Noida, 201310
Gautam Buddha Nagar
UTTAR PRADESH |
7011015389
Kapilchawda0050@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| India Physio Clinic |
No Objection Certificate |
| Institutional NTCC Committee, Amity Institute of Health Allied Sciences, Amity University Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cognitive Dual task training |
we will make the patient do cognitive task like doing mental subtraction while walking forward, backward, side walking, crossing hurdles. we will follow these interventions for the duration of 4 weeks for 3 sessions per week for a duration of 30 minutes for each session |
| Intervention |
Motor Dual task training |
we will make the patients do motor task like holding a tray while walking forward, backward, side walking, crossing hurdles. we will follow these interventions for the duration of 4 weeks for 3 sessions per week for a duration of 30 minutes for each session |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients having Hemiparesis after a single stroke.
Age between 20-80 years
A score of at least 24 on the Montreal Cognitive Assessment (MoCA).
Stable health status allowing for involvement in the testing procedure and intervention
Able to walk at least 10m independently without the use of any assistive device
Able to use the healthy upper extremity to hold a tray in order to complete the protocol. |
|
| ExclusionCriteria |
| Details |
Any disability other than stroke that would prevent gait training.
Any medical condition for which exercise was not recommended.
Any disease that could potentially interfere with the study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Berg Balance Scale, 10m Walk test |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Timed Up and Go test |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
05/02/2024 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study is Randomised, Single Blinded Parallel group, Single Centred trial which aims to compare the efficacy of Motor Dual Task training and Cognitive Dual Task training in improving the Gait and Balance of Stroke Patients. Dual task training involves simultaneously performing two tasks: a primary motor task, like walking, and a secondary cognitive or attention-demanding task, such as counting backward or carrying an object. This challenges the patient’s ability to divide their attention between multiple tasks, simulating real-life scenarios where walking requires simultaneous cognitive processing. The purpose of this study is to compare the effects of Motor and Cognitive dual task training on improving gait and balance of stroke patients. Outcome measures used to assess are Berg Balance Scale, Timed up and go test and 10m walk test. |