| CTRI Number |
CTRI/2024/08/072320 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
The study investigates whether exercises using both arms can improve walking in people recovering from a recent stroke. |
|
Scientific Title of Study
|
Effect of Bimanual task with upper extremity exercises on Gait parameters in subacute stroke patients: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi Runwal |
| Designation |
PG student |
| Affiliation |
MGM School of Physiotherapy |
| Address |
Department of Neuro Physiotherapy no 5, MGM School of physiotherapy Gate No. 3
N6 cidco Chh Sambhajinagar 431001, Maharashtra, India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7058889642 |
| Fax |
|
| Email |
sakshirunwal3001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pallavi Palaskar |
| Designation |
Associate Professor |
| Affiliation |
MGM School of Physiotherapy |
| Address |
Department of Neuro Physiotherapy no 5, MGM School of physiotherapy Gate No. 3
N6 cidco Chh Sambhajinagar 431001, Maharashtra, India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9604487806 |
| Fax |
|
| Email |
pallavi.palaskar@mgmsop.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Palaskar |
| Designation |
Associate Professor |
| Affiliation |
MGM School of Physiotherapy |
| Address |
Department of Neuro Physiotherapy no 5, MGM School of physiotherapy Gate No. 3
N6 cidco Chh Sambhajinagar 431001, Maharashtra, India
MAHARASHTRA
431001
India |
| Phone |
9604487806 |
| Fax |
|
| Email |
pallavi.palaskar@mgmsop.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of neuro physiotherapy no. 5 MGM School of Physiotherapy,N6 Cidco Aurangabad 431001, maharashtra, India |
|
|
Primary Sponsor
|
| Name |
MGM School of Physiotherapy |
| Address |
Department of neuro physiotherapy no. 5 MGM School of Physiotherapy,N6 Cidco Aurangabad 431001, maharashtra, India |
| 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 Sakshi Runwal |
MGM School of Physiotherapy Neuro OPD room number 5 |
MGM School of physiotherapy, C building N6 Cidco Chhatrapati Sambhajinagar Maharashtra 431001, India
Aurangabad
MAHARASHTRA |
7058889642
sakshirunwal3001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Missions Ethics committee for Research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bimanual task training |
Dressing :1) Putting on shoes
2) Putting on pajamas
3)Putting on socks.Undressing (sitting)-1) Taking off shoes.
2) Taking off pajamas.
3)Taking off socks.
Taking care of hygiene-1) Dressing.
2) Washing face.
3)Washing hands.
Activities of Daily Living 1) Holding a dish.
2)Clean the table.
3) Opening the bottle.
4)Drinking from a glass with both hands.
5)Carrying a food tray.
6)Push a chair in and out of the table.
This protocol will be carried out for 60 mins/session/3 days/week/4 weeks.
Upper extremity exercises 1) Wall climbing exercises 2) Pendular exercises 3) Wrist pumps
This protocol will be carried out for 60 mins/session/5 days/week/4 weeks.
|
| Comparator Agent |
Standard Physiotherapy Protocol |
Standard physiotherapy protocol
Stretching – Tibialis Anterior stretch
Hamstring stretch
Stretching will be done for 30 sec holds with 3 repetitions.
Strengthening - Hip abductors
Hip extensors
Knee flexors
Ankle dorsiflexors
Sit to stand exercise
Bed side transitions
Parallel bar training
Spot marching
Side walking against the wall
Upper extremity exercises
1)Wall climbing exercise
2)Pendular exercise
3) Wrist pumps.
This protocol will be carried out for 45 mins/session/5 days/week/4 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
)Patients with Subacute stroke.
2)Patients of left MCA Stroke.
3)Patients of either gender.
4)Age- 40-59 years. (middle aged adults with subacute stroke)
5)Patient is able to walk independently indoor only without assistive device.
|
|
| ExclusionCriteria |
| Details |
1)Stroke patients with medical or physical complications such as pressure ulcers, contracture, etc.
2)Stroke patients who are unable to follow commands and instructions.
3)Any visual or hearing impairment.
4) Any associated psychiatric illness.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
step length
Stride length
Cadence
Tinetti performance-oriented mobility assessment |
step length: baseline and week 4
Stride length: baseline and week 4
Cadence: baseline and week 4
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tinetti performance-oriented mobility assessment |
Tinetti performance-oriented mobility assessment: baseline and week 4 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
Modification(s)
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/08/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The aim of the study is to find out the effect of bimanual task with upper limb exercises on gait parameters in sub- acute stroke patients and Objective is to find out the pre and post bimanual task intervention differences in outcome measures on gait parameters in subacute stroke patients in experimental group, To compare the effectiveness of bimanual task with upper extremity exercises verses standard physiotherapy treatment on gait parameters in subacute stroke patients and to find out the pre and post standard Physiotherapy intervention differences in outcome measures on gait parameters in subacute stroke patients in conventional group.
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