| CTRI Number |
CTRI/2023/02/049507 [Registered on: 07/02/2023] Trial Registered Prospectively |
| Last Modified On: |
18/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Yoga Intervention ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Changes in ability to perform ground level activity and balance after 12-week Yoga training in stroke patients |
|
Scientific Title of Study
|
Effect of 12 week Yoga intervention on ground level activities and balance in patients with subacute and chronic stroke |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Trupti Yashodhara Poojary |
| Designation |
Master of Physiotherapy Student |
| Affiliation |
MGM School of Physiotherapy MGM Institute of Health Sciences |
| Address |
MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy second floor Room no 55 MGM Hospital Sector 1 plot no 1 and 2 Kamothe Navi Mumbai Taluka Panvel
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
Poojarytrupti@mgmsopnm.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrita Ghosh PT |
| Designation |
Assistant Professor HOD of Neuro Physiotherapy |
| Affiliation |
MGM School of Physiotherapy MGM Institute of Health Sciences |
| Address |
MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy second floor Room no 55 MGM Hospital Sector 1 plot 1 and 2 Kamothe Navi Mumbai Taluka Panvel
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
aghosh@mgmsopnm.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrita Ghosh PT |
| Designation |
Assistant Professor HOD of Neuro Physiotherapy |
| Affiliation |
MGM School of Physiotherapy MGM Institute of Health Sciences |
| Address |
MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy second floor Room no 55 MGM Hospital Sector 1 plot 1 and 2 Kamothe Navi Mumbai Taluka Panvel
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
aghosh@mgmsopnm.edu.in |
|
|
Source of Monetary or Material Support
|
| MGM School of Physiotherapy MGM Institute of Health Sciences MGM Educational campus Sector 1 plot no 1 and 2 Kamothe Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
MGM School of Physiotherapy MGM Institute of Health Sciences |
| Address |
MGM School of Physiotherapy MGM Institute of Health Sciences MGM Educational Campus Sector 1 plot no 1 and 2 Kamothe Navi Mumbai Taluka Panvel Raigad Maharashtra 410209 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 |
| Trupti Yashodhara Poojary |
MGM School of Physiotherapy |
MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy second floor Room no 55 MGM Hospital Sector 1 plot no 1 and 2 Kamothe Navi Mumbai Taluka Panvel Raigad Maharashtra 410209
Raigarh
MAHARASHTRA |
02227437866
Poojarytrupti@mgmsopnm.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Mahatma Gandhi Missions Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G461||Anterior cerebral artery syndrome, (2) ICD-10 Condition: G460||Middle cerebral artery syndrome, (3) ICD-10 Condition: G462||Posterior cerebral artery syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Control group will be provided 12 weeks of conventional therapy with supervised sessions for 2-3 days/week for 60 minutes including breathing exercises specific to gait, eccentric control and strength of lower limb. |
| Intervention |
Sukshma Vyayama Tadasana Utkatasana Malasana Ardha Padmasana Vajrasana Virabhadrasana Bhramari pranayama |
Interventional group will be provided 12weeks (three sessions/week) supervised Yoga sessions for 2-3 days/week for 60 minutes. The Yoga Asanas will include Sukshma Vyayama, Tadasana, Utkatasana, Malasana, Ardha Padmasana, Vajrasana, Virabhadrasana, Bhramari pranayama. In the initial 4 weeks, the participants will perform 3 repetitions each asana with 15 seconds hold/repetition. In the 5th to 8th week based on the tolerance and performance the participants will be given progression dose i.e. each asana will be performed 4 times with 30 second hold/repetition.
A similar progression will be followed in the final 9-12 weeks based on tolerance and performance
The frequency of whole intervention will be thrice a week and the duration will be 12 weeks
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Population Stroke patients (subacute and chronic stroke) According to ICD 10 classification Middle cerebral artery syndrome (G460), Anterior cerebral artery syndrome(G461), Posterior cerebral artery syndrome(G462)
MMSE score greater than or equal to 24 points i.e. normal cognition
Functional independence measure score greater than or equal to 100
Brunnstrom Stage of the lower extremity: stage 3-stage 6
Both male and female participants will be included |
|
| ExclusionCriteria |
| Details |
Acute stroke patients (24 hours- 3 month) According to ICD 10 classification Code:(163)
Hemorrhagic stroke patients -According to ICD 10 classification Code: (161.9)
Juvenile and Adolescents population.
Patients with history of lower limb fractures < 1 year old.
Patient with h/o recent soft tissue injury < 3 months
Patient h/o rheumatic disease (M06.9)
Mental and Behavioral disorders F00-F99 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| MGMGLAE (Ground Level Activities Exposure) |
Baseline 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Modified Ashworth Scale MAS Spasticity
2)SMC/VCA Synergy
3)Movement analysis profile Gait squatting sit to stand
4)Kinovea software
5)Trunk Impairment Scale TIS
6)Power-track handheld Dynamometer Muscle Strength of lower-extremity
7)Squat test STREAM standing and walking domain Mini BES Test Scale
|
Baseline 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2023 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will compare the effects of Yoga on
ground-level activities and balance in patients with subacute and chronic
stroke. The study will be conducted for 12 weeks 2-3 day/week supervised
program for 60 minutes. The intervention will be Yoga techniques and
conventional physiotherapy for the experimental group and conventional physiotherapy for the control group. The
primary outcome measure will be MGMGLAE. The secondary outcome measure will
be the Modified Ashworth Scale MAS Spasticity, SMC/VCA- Synergy Movement analysis
profile Trunk Impairment Scale TIS Kinovea software Power-track handheld
Dynamometer-Muscle Strength of lower extremity Mini BES Test Scale. Pre and Post-intervention results will be analyzed. |