| 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
|
|
|
Primary Sponsor
|
| Name |
Manipal University |
| Address |
Light House, Hill road,Mangalore, 575003 |
| 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 |
| 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
|
|
|
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. |