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CTRI Number  CTRI/2021/07/034731 [Registered on: 09/07/2021] Trial Registered Prospectively
Last Modified On: 06/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Effect of early motility on involuntary urination in acute stroke patients-An Interventional study 
Scientific Title of Study   Effect of early functional mobility on urinary incontinence in acute stroke patients-An Interventional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  G KAVYA SREE 
Designation  post graduate student 
Affiliation  kasturba medical college, manipal university,mangalore. 
Address  Department of physiotherapy, KMC hospital,Jyothi circle , Mangalore, Dakshina Kannada KARNATAKA

Dakshina Kannada
KARNATAKA
575002
India 
Phone    
Fax    
Email  kavya.sree@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Abraham M Joshua 
Designation  Senior Associate Professor 
Affiliation  kasturba medical college, manipal university,mangalore 
Address  Department of physiotherapy, KMC hospital,Jyothi circle , Mangalore, Dakshina Kannada KARNATAKA

Dakshina Kannada
KARNATAKA
575003
India 
Phone  9886188221  
Fax    
Email  abraham.joshua@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  G KAVYA SREE  
Designation  post graduate student 
Affiliation  kasturba medical college, manipal university,mangalore. 
Address  Department of physiotherapy, KMC hospital,Jyothi circle , Mangalore, Dakshina Kannada KARNATAKA

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9848894824  
Fax    
Email  kavya.sree@learner.manipal.edu  
 
Source of Monetary or Material Support  
manipal university 
 
Primary Sponsor  
Name  Manipal University 
Address  Light House, Hill road,Mangalore, 575003 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
G Kavya Sree  KMC Mangalore  Department of physiotherapy, KMC hospital,Jyothi circle , Mangalore, Dakshina Kannada KARNATAKA
Dakshina Kannada
KARNATAKA 
9848894824

kavya.sree@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee ,Kasturba medical college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G89-G99||Other disorders of the nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mobilisation  Mobilization consist of exercises which normalize the tone, core strengthening exercises, facilitating bed rolling, sit to stand transfers, weight shifts, standing balance, proprioception training in standing balance, reach out activities, gait training will be given with assistance or manual support according to the subjects capacity once in a day and for a week . 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Patients diagnosed with acute stroke patients.
Patients with minimum score 48/100 in trunk control test are taken.
 
 
ExclusionCriteria 
Details  Patients with urinary tract infection and any renal diseases.
Patients with prostrate hypertrophy and prostrate cancer who are medically screened by the urologist.
Patients on medication which causes urinary incontinence :
i.Oral estrogen
ii.Alpha blockers
iii.Sedative hypnotics
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Self-reported urinary incontinence questionnaire  baseline taken one day prior to mobilization and again taken on consecutive 7th day 
 
Secondary Outcome  
Outcome  TimePoints 
Post void ultrasound residual volume  baseline taken one day prior to mobilization and again taken on consecutive 7th day 
 
Target Sample Size   Total Sample Size="57"
Sample Size from India="57" 
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)   16/08/2021 
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   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Subjects with acute stroke diagnosed by a neurologist who are referred to department of physiotherapy will be approached. The consent will be taken from the subjects who are willing considering the inclusion and exclusion criteria, the appropriate subjects will be selected.The purpose of the study will be explained to the patient attendees. 
In each patient functional mobility and urinary incontinence is assessed by using outcome measures. Functional mobility is assessed primarily by ’STREAM’ scale, and secondarily by Fugl Meyer assessment scale for lower limb . Urinary incontinence is assessed by self-reported urinary incontinence questionnaire and pre-post ultrasound residual volume.

The patients will be assessed by the outcome measure a day prior to out of bed mobilization of the patient, when medically stable and is advised by the neurologist to mobilize the patient .Mobilization consists of exercise which normalize the tone, core strengthening exercises, facilitating bed rolling, sit to stand transfers, weight shifts, standing balance, proprioception training in standing balance, reach out activities, gait training will be given with assistance or manual support according to the subjects capacity. A baseline scores are taken of the outcome measures assessed. Again same will be repeated on the 7th consecutive day from the first assessed day after basic mobility exercises. For urinary incontinence ultrasound residual volume is assessed within 10 minutes post voiding. Now, the baseline scores which are taken are compared with the scores achieved from second time assessment  in the same subjects.
 
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