| CTRI Number |
CTRI/2024/05/067840 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association between neurogenic bladder symptoms and fall in acute hospitalized stroke |
|
Scientific Title of Study
|
Association between neurogenic bladder symptoms and fall in acute hospitalized stroke: A cross-sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jeekshita Kulal |
| Designation |
Post graduate student |
| Affiliation |
Nitte Institute of Physiotherapy,NITTE(Deemed to be University) |
| Address |
Department of Physiotherapy, Room no.20, Second base division
, Nitte Institute of Physiotherapy, NITTE Deemed to be University, Deralakatte, Mangaluru.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9164625575 |
| Fax |
|
| Email |
jeekshitakulal18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purusotham Chippala |
| Designation |
Professor |
| Affiliation |
Nitte Institute of Physiotherapy,NITTE(Deemed to be University) |
| Address |
Department of Physiotherapy, Room no.20, Second base division
, Nitte Institute of Physiotherapy, NITTE(Deemed to be University), Deralakatte, Mangaluru.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9916460185 |
| Fax |
|
| Email |
chippala_puru@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Purusotham Chippala |
| Designation |
Professor |
| Affiliation |
Nitte Institute of Physiotherapy,NITTE(Deemed to be University) |
| Address |
Department of Physiotherapy, Room no.20, Second base division
, Nitte Institute of Physiotherapy, NITTE(Deemed to be University), Deralakatte, Mangaluru.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9916460185 |
| Fax |
|
| Email |
chippala_puru@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Nitte Institute of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Nitte Institute of Physiotherapy |
| Address |
Nitte Institute of Physiotherapy Nitte Deemed to be University,
Nithyananda Nagar,Deralakatte Mangaluru Dakshina Kannada Karnataka 575018 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 |
| Jeekshita Kulal |
Justice K.S Hegde Charitable Hospital |
Department no.10,Department of General Medicine, and Department no.12,Department of Neuro Surgery, Medical Science Complex,Deralakatte,Mangaluru-575018
Dakshina Kannada
KARNATAKA |
9164625575
jeekshitakulal18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Nitte Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, (2) ICD-10 Condition: N319||Neuromuscular dysfunction of bladder, unspecified, (3) ICD-10 Condition: W19||Unspecified fall, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age above 45 and less than or equal to 60 years
2. Both males and females are included
3. Hospital stay less than or equal to 7 day
4. Diagnosed with Acute stroke and has bladder symptom
5.The lesion was confirmed using brain magnetic resonance imaging or computed tomography imaging
6. Admission as an inpatient in medicine and neurosurgery unit |
|
| ExclusionCriteria |
| Details |
1. Bedridden patients
2. Unconscious patients
3. Patient with pelvic organ prolapse , prostate related operation history, bladder cancer, previous history of stroke along with acute stroke
4. With cognitive impairment(mini-mental state examination score less than 25)
5. Taking any psychiatric medication
6. Severe comorbidities like brain tumor, Parkinson’s disease, and multiple sclerosis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| short form of neurogenic bladder symptom score(NBSS-SF) |
Once at the time of Assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Morse Fall Scale(MFS) |
Once at the time of assessment |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "67"
Final Enrollment numbers achieved (India)="67" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
16/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Stroke represents one of the leading causes of mortality and disability for adults.Patients who survive an acute stroke are reported to face numerous early and late complications.Bladder symptoms including incontinence,storage,and voiding issues are highly prevalent in these population.Falls negatively affect the quality of life ,causing individual pain and suffering,leading to functional decline,and are associated with significant healthcare resource use.It is undeniable that neurogenic bladder symptoms and in particular storage and voiding ,is a marker for frailty,and frailty is strongly associated with falls the rationale is that fall is due to rushing to toilet or slipping in their own urine following and episode of incontinence ,however the association is neither understood nor studied.hence the need of the study is to find the association between neurogenic bladder symptom and fall in acute hospitalized stroke patients. |