| CTRI Number |
CTRI/2024/12/077551 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Correlational Study |
| Study Design |
Other |
|
Public Title of Study
|
The link Between Trunk Stability and Breathing Muscle Strength in people with Stroke |
|
Scientific Title of Study
|
Correlation Between Trunk Stability and Inspiratory Muscle Strength in Individuals with Stroke |
| Trial Acronym |
NIl |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Megha S |
| Designation |
Postgraduate student |
| Affiliation |
Ramaiah College of Physiotherapy-RUAS |
| Address |
Ramaiah College of Physiotherapy M S Ramaiah Nagar,MSRIT post, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9740458124 |
| Fax |
|
| Email |
meghamona33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nanda kumar |
| Designation |
Assistant Professor |
| Affiliation |
Ramaiah College of Physiotherapy-RUAS |
| Address |
Ramaiah College of Physiotherapy M S Ramaiah Nagar,MSRIT post, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9900952657 |
| Fax |
|
| Email |
nandakumar.rcp@msruas.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Nanda kumar |
| Designation |
Assistant Professor |
| Affiliation |
Ramaiah College of Physiotherapy-RUAS |
| Address |
Ramaiah College of Physiotherapy M S Ramaiah Nagar,MSRIT post, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9900952657 |
| Fax |
|
| Email |
nandakumar.rcp@msruas.ac.in |
|
|
Source of Monetary or Material Support
|
| Ramaiah College of Physiotherapy, M S Ramaiah Nagar, MSRIT post, Bangalore 560054 |
| Ramaiah Medical college and hospital, M S Ramaiah Nagar, MSRIT post, Bangalore 560054 |
| Ramaiah Memorial Hospital,M S Ramaiah Nagar, MSRIT post, Bangalore 560054 |
|
|
Primary Sponsor
|
| Name |
Megha S |
| Address |
Ramaiah College of Physiotherapy, M S Ramaiah Nagar, MSRIT post, Bangalore 560054 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Megha S |
Ramaiah Medical College and Hospital |
First floor, Department of Neurology and Neurosurgery, M S Ramaiah Nagara, MSRIT Post, Bangalore-560054
Bangalore
KARNATAKA |
9740458124
meghamona33@gmail.com |
| Megha S |
Ramaiah Memorial Hospital |
Eight floor, Department of Neurology and Neurosurgery and Basement, Neurorehabilitation M S Ramaiah Nagara, MSRIT Post, Bangalore-560054
Bangalore
KARNATAKA |
09740458124
meghamona33@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee M S Ramaiah Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G89-G99||Other disorders of the nervous system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Medically diagnosed Ischemic and Hemorrhagic type of Stroke
2)Supratentorial Stroke is a type of stroke that occurs in the area of brain located above the tentorium cerebelli, a membrane that separates the cerebellum from cerebral hemispheres
3)Time since stroke is less than 3 months
4)Patients should be able to take volitional breaths on command
|
|
| ExclusionCriteria |
| Details |
1) Facial Palsy caused by a stroke
2) Infratentorial Stroke – type of stroke that occurs in the area of brain located below the tentorium cerebelli
3)Sensory Aphasia- type of language disorder that occurs due to damage in wernicke’s area of temporal lobe. Patients have difficulty with following instructions
4)Presence of chest disease on Medical History |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Maximum Inspiratory Pressure MIP
2)Trunk Impairment Scale TIS |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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)
|
12/12/2024 |
| 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 diaphragm is involved in both respiratory and trunk function.The application of the diaphragm’s dual role in clinical practice especially in the first 3 months post-stroke is not fully understood as there are other ways by which trunk stability can be improved – core stabilization exercises, PNF, the task of reaching while sitting.Respiratory muscle strength can have a greater impact on trunk stability during the first 3 months after stroke because this is the period of fastest recovery. Therefore, the need arises to correlate trunk stability and inspiratory muscle strength in individuals with stroke. |