| CTRI Number |
CTRI/2022/04/041584 [Registered on: 01/04/2022] Trial Registered Prospectively |
| Last Modified On: |
30/03/2022 |
| 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
|
A study to see extra effect of pranayama breathing on cognition ,balance and functional mobility in people with sub acute stroke or paralysis |
|
Scientific Title of Study
|
Additive effect of pranayamic breathing on cognition, balance and functional mobility in individuals with subacute stroke - An experimental study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shiv Solanki |
| Designation |
PG Student |
| Affiliation |
S. S. Agrawal Institute of Physiotherapy and Medical Care Education |
| Address |
9,Rohitvas,Talavchora TA. Chikhli DIST. Navsari
Agrawal college campus, Viranjali van marg, devina park, navsari.396445
Navsari
GUJARAT
396521
India |
| Phone |
9512258545 |
| Fax |
|
| Email |
shivkumar_solanki@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hetvi G Bhatt |
| Designation |
Assistant Professor and PHD Scholar |
| Affiliation |
S. S. Agrawal Institute of Physiotherapy and Medical Care Education |
| Address |
110/B, rajlakshmi society, shailesh park, behind vidyakunj school, navsari.
Agrawal college campus, Viranjali van marg, devina park, navsari.396445
Navsari
GUJARAT
396445
India |
| Phone |
8905557484 |
| Fax |
|
| Email |
dr_hetvi2@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shiv Solanki |
| Designation |
PG Student |
| Affiliation |
S. S. Agrawal Institute of Physiotherapy and Medical Care Education |
| Address |
9,Rohitvas,Talavchora TA. Chikhli DIST. Navsari
Agrawal college campus, Viranjali van marg, devina park, navsari.396445
Navsari
GUJARAT
396521
India |
| Phone |
9512258545 |
| Fax |
|
| Email |
shivkumar_solanki@outlook.com |
|
|
Source of Monetary or Material Support
|
| S.S. Agrawal Institute of Physiotherapy and Medical Care Education, Navsari, Gujarat, India.396445 |
|
|
Primary Sponsor
|
| Name |
Shiv Solanki |
| Address |
9, Rohitvas, Talavchora TA. Chikhli DIST. Navsari Pincode-396521 |
| 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 Shlesha Vaidya |
S. S. Agrawal Institute of Physiotherapy and Medical Care Education |
Department of Physiotherapy, Ground Floor, Agrawal College Campus, Viranjali Van marg, devina park, Navsari-396445
Navsari
GUJARAT |
9427285250
drsmvaidya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee the sarvajanik college of physiotherapy |
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 |
| Intervention |
Exercise Therapy |
Conventional therapy: 1) Stretching exercise for tight muscles both upper and lower extremity (30 sec hold for 3 times) 2) Active assisted training for subjects who will not able to perform full range exercises actively (apply talcum on table if needed to reduce friction) (10 times for each) 3) Active movements for subjects who will able to perform tasks as mentioned above (10 times for each) 4) Manual dexterity exercise listed below (10 times for each)5) Balance training - both static and dynamic balance ( 10 times for each )6) Sit to stand training (10 times for each )7) Weight bearing training 8) Gait training-Walking training will be given for 9 meters (30 feet) |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Pranayamic Breathing and Exercise Therapy |
Alternate nostril breathing and Bhramari pranayama:The intervention will be carried out in a calm and peaceful atmosphere. The intervention of alternate nostril breathing with therapist command for 20 minutes will be given to the subjects. Alternate nostril breathing is practiced by alternating the inhalation and exhalation between the left and the right nostrils. Rest Period of few seconds will be also given to the subjects after every 5 minutes of alternate nostril breathing. Subjects will be also asked to perform bharamari pranayama for 10 minutes for repetition of 3 to 21 times as per their comfort level. In Bhramari pranayama, the practitioner will sit in any comfortable posture and inhale and exhale through nostrils slowly and deeply. While exhaling, will have to produce sound (humming sound) like bumble bee strictly through
nasal airways, keeping oral cavity closed by the lips, ears closed by fingers.
Conventional therapy: 1) Stretching exercise for tight muscles both upper and lower extremity (30 sec hold for 3 times) 2) Active assisted training for subjects who will not able to perform full range exercises actively (apply talcum on table if needed to reduce friction) (10 times for each)
3) Active movements for subjects who will able to perform tasks as mentioned above
(10 times for each) 4) Manual dexterity exercise listed below (10 times for each)5) Balance training - both static and dynamic balance ( 10 times for each )6) Sit to stand training (10 times for each )7) Weight bearing training 8) Gait training-Walking training will be given for 9 meters (30 feet)
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Stroke diagnosed with CT/ MRI or ascertained by medical reports by qualified medical professionals.
2.1 to 6 months of stroke
3.Minimum score of MMSE more than and equal to 18
4.Individual with score more than and equal to 21 of BBS |
|
| ExclusionCriteria |
| Details |
1.Subjects who are not able to understand simple commands
2.Any neurological disease other than stroke.
3.Visual or auditory loss
4.Severe sensory and perceptual deficits |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mini-Mental State Examination (MMSE) |
Baseline, 2 week and 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The Berg Balance Scale (BBS)
Timed Up and Go Test (TUGT) |
Baseline, 2 week and 4 week |
|
|
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)
|
09/04/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
AIMS AND OBJECTIVES :➢ To determine effect of pranayamic breathing along with conventional therapy on
cognition, balance and functional mobility in individuals with subacute stroke. ➢ To compare effects of pranayamic breathing along with conventional therapy and
conventional therapy alone on cognition, balance and functional mobility in individuals
with subacute stroke. |