| CTRI Number |
CTRI/2024/07/071461 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Added effect of diaphragmatic facilitatory techniques in chronic stroke individuals |
|
Scientific Title of Study
|
Added effect of diaphragmatic facilitatory techniques on respiratory muscle strength in chronic 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 |
Yukta Churi |
| Designation |
PG student |
| Affiliation |
Dr. D Y Patil College of Physiotherapy Pimpri PUNE |
| Address |
D Y Patil college of physiotherapy, Pimpri Pune
Neuroscience physiotherapy department, ground floor
Pune
Maharashtra
411018
India
Department of neurosciences, 3rd floor, Dr. D.Y Patil College of
Physiotherapy, Pimpri.
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9765905687 |
| Fax |
|
| Email |
churiyukta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjivani Kamble |
| Designation |
Associate professor |
| Affiliation |
Dr. D Y Patil College of Physiotherapy Pimpri PUNE |
| Address |
3rd floor, Neuro physiotherapy department ,Cabin number;2
DR. D Y Patil college of Physiotherapy Pimpri,Pune
Pune
Maharashtra
411018
India
Department of neurosciences, 3rd floor, Dr. D.Y Patil College of
Physiotherapy, Pimpri.
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9860117191 |
| Fax |
|
| Email |
sanjivani.dhote@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjivani Kamble |
| Designation |
Associate professor |
| Affiliation |
Dr. D Y Patil College of Physiotherapy Pimpri PUNE |
| Address |
3rd floor, Neuro physiotherapy department, cabin number:2
DR. D Y Patil college of Physiotherapy Pimpri,Pune
Pune
Maharashtra
411018
India
Department of neurosciences, 3rd floor, Dr. D.Y Patil College of
Physiotherapy, Pimpri.
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9860117191 |
| Fax |
|
| Email |
sanjivani.dhote@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| DR. D Y Patil Hospital and Research centre,
2nd floor, Physiotherapy Opd
Pimpri , Pune
411018
Maharashtra,
India
Maharashtra,
India |
|
|
Primary Sponsor
|
| Name |
Yukta Churi |
| Address |
SECTOR 25 , LIG Colony ,Big India Chawk,Nigdi, PUNE
Maharashtra
India
pin:411044 |
| 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 Sanjivani Kamble |
DR. D Y Patil College of Physiotherapy Pune |
3rd floor, Neuro physiotherapy department, room number 1
DR. D Y Patil College of Physiotherapy Pune
411018
Maharashtra
India
Pune
MAHARASHTRA |
9860117191
sanjivani.dhote@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Dr. D Y Patil College of Physiotherapy,Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional therapy |
Conventional exercise therapy will be given to the other group for 3 days
in a week which shall continue for 4 weeks. The conventional therapy includes stretching of the hamstring muscle and quadriceps along with pirigormis and iliotibial band for 90 seconds . Sit to stand will be given with 10 repetition,gait training for 15 minutes spot marching for 3 sets of 10 repeatation , parallel bar walking for 3 rounds,balance training on wobble board,reach outs 10 repeatation 3 sets.
|
| Intervention |
Diaphragmatic Facilitatory Technique |
The individual will be given 1 session of diaphragmatic Facilitatory techniques for 3 days in a week. The protocol shall continue for 4 weeks
simultaneously. First 2 weeks Segmental breathing will also be given with facilitation techniques which include Relaxing techniques like contract relax method,repatterning,sniffing,diaphragmatic scoop,lateral costal facilitation technique,upper chest inhibition technique,normal timing technique. All the techniques will be given with 3 repeatations .
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
chronic stroke patients
mini mental state examination score above 24 |
|
| ExclusionCriteria |
| Details |
history of cardiopulmonary disease
neurological condition except stroke
visual and auditory deficit
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Respiratory Pressure Meter
Chest expansion
|
pre value 0th week
post value 4th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ultrasonography |
pre value 0th week
post value 4th week
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
08/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/08/2024 |
| 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
|
Previously the studies have been done to find out the difference in the diaphragm thickness in normal individuals and stroke patients, in which it was found that diaphragm thickness at TLC in stroke patients was significantly thinner in affected side as compared to unaffected side due to reduced strength of muscle ,when compared with healthy individuals. Hence there can be possibility of reduced exercise tolerance and increased work of breathing in stroke patients.Hence in this study we will be focusing on finding out if the diaphragmatic facilitation techniques when given to chronic stroke patients will it help in improving the strength of respiratory muscles which shall eventually improve the thickness of diaphragm and chest expansion and also Respiratory Pressure Meter device values in stroke patients. |