| CTRI Number |
CTRI/2024/04/066316 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Development and validation of outcome measure to assess the physical activity preparedness in patients with one sided body weakness or paralysis. |
|
Scientific Title of Study
|
Development and validation of outcome measure to assess the physical activity readiness in patients 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 |
Poorvi Shingatgeri |
| Designation |
PG student |
| Affiliation |
Manipal College Of Health Professionals, Manipal Academy of higher education,Manipal |
| Address |
Room number 215, Department of physiotherapy, second floor, Manipal College Of Health Professionals, Manipal Academy of higher education, Madhav Nagar, Manipal, Udupi, Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
917558308815 |
| Fax |
|
| Email |
poorvi1mchpmpl2023@learner.manipal.eddu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Senthil Kumaran D |
| Designation |
Additional Professor |
| Affiliation |
Manipal College Of Health Professionals,Manipal Academy Of higher Education, |
| Address |
Room number 215, Department of physiotherapy, second floor, Manipal College Of Health Professionals, Manipal Academy of higher education, Madhav Nagar, Manipal, Udupi, Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9986910303 |
| Fax |
|
| Email |
senthil.kumaran@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr John Solomon |
| Designation |
Professor, HOD of department of PhysiotherapyMCHP,MAHE,Manipal |
| Affiliation |
Manipal College Of Health Professionals, Manipal Academy Of higher Education, |
| Address |
Room number 215, Department of physiotherapy, second floor, Manipal College Of Health Professionals, Manipal Academy of higher education, Madhav Nagar, Manipal, Udupi, Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9945670671 |
| Fax |
|
| Email |
john.solomon@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy, Manipal College Of Health Professionals, Manipal Academy of higher education, Manipal, Udupi, Karnataka India- 576104 |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy |
| Address |
Department of physiotherapy, Manipal College Of Health Professionals, Manipal Academy of higher education, Manipal, Udupi, Karnataka India- 576104 |
| Type of Sponsor |
Other [Educational Institute] |
|
|
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 |
| Poorvi Shingatgeri |
Kasturba Hospital |
102 N1 Physiotherapy OPD, Baliga Block, Kasturba Hospital, Madhav Nagar Manipal, Udupi, Karnataka.
Udupi
KARNATAKA |
917558308815
poorvi1mchpmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kasturba medical college and kasturba hospital institutional ethics committee - 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
patients with stroke for focus group discussion and
experts with minimum 2 years of experience as physiotherapist /occupational therapist/exercise physiologist/clinical psychologist for expert interview |
|
| ExclusionCriteria |
| Details |
patient with recurrent episode of stroke with cognitive and perceptual issues and patients with acute or chronic musculoskeletal comorbidities that affect sedentary behaviour and physical activity for focus group discussion |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| a tool that measures physical activity readiness of patients with stroke in the form of questionnaire |
Baseline assessment will be done once at the time of recruitment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
06/05/2024 |
| 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
|
This study procedure includes a focus group discussion with 5 patients with stroke and the discussion will focus on their perseverance regarding readiness for physical activity. An expert interview session will then be arranged with 5 experts in the field of physiotherapy, clinical psychology, exercise physiologists, and occupational therapists working with stroke regarding the readiness of the patient for physical activity post-stroke. The data will be stored and a questionnaire draft will be made which will later be finalised after duplicate removal. This final questionnaire will be subjected to face validity and discriminant validity. For discriminant validity, Fibion(accelerometer) will be attached to the thigh to a total of 10 patients for 3 consecutive days from 9 am-6 pm. The data will be collected and analysed with fibion software. |