| CTRI Number |
CTRI/2024/06/069259 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
The study is to determine psychometric properties of The Bedside Upper Limb Functional Evaluation Tool Among Stroke Subjects |
|
Scientific Title of Study
|
Reliability And Predictive Validity Of The
Bedside Upper Limb Functional Evaluation
Tool Among Stroke Subjects– A
Psychometric 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 |
Shruti Mohapatra |
| Designation |
PG Student |
| Affiliation |
Kasturba Medical College,Mangalore, MAHE |
| Address |
Department Of Physiotherapy, Kasturba Medical College,
Mangalore, Centre for Basic Sciences, Bejai, Mangalore
Dakshina Kannada
575004
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9123624448 |
| Fax |
|
| Email |
shruti.mchpmlr2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abraham M Joshua |
| Designation |
Associate Professor-Senior Scale |
| Affiliation |
Kasturba Medical College,Mangalore, MAHE |
| Address |
Department Of Physiotherapy, Kasturba Medical College,
Mangalore, Centre for Basic Sciences, Bejai, Mangalore
Dakshina Kannada
575004
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9886188221 |
| Fax |
|
| Email |
abraham.joshua@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abraham M Joshua |
| Designation |
Associate Professor-Senior Scale |
| Affiliation |
Kasturba Medical College,Mangalore, MAHE |
| Address |
Department Of Physiotherapy, Kasturba Medical College,
Mangalore, Centre for Basic Sciences, Bejai, Mangalore
Dakshina Kannada
575004
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9886188221 |
| Fax |
|
| Email |
abraham.joshua@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy,Kasturba Medical College,Centre for Basic Sciences,Bejai,Mangalore
District - Dakshina Kannada
Karnataka
India
575004 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Dr Abraham M Joshua |
Kasturba Medical College Attavar , Kasturba Medical College Jyothi |
Physiotherapy Department,5th Floor Dr. BR Ammbedkar Circle,Hampankatta
Mangalore
575001
Dakshina Kannada
Dakshina Kannada
KARNATAKA |
9886188221
abraham.joshua@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College , Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects diagnosed with primary ischemic/hemorrhagic supratentorial
stroke with upper limb involvement.
2.Single episode of acute/subacute stroke |
|
| ExclusionCriteria |
| Details |
Patients affected with any other neurological conditions.
Severe cognitive problems (MoCA score less than 26)
Any pre-existing upper limb musculoskeletal conditions which may
affect the testing method.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Bedside Upper Limb Functional Evaluation Tool (BUFET)
Wolf Motor Function Test (WMFT) |
Day 1 - Both outcomes will be assessed
Day 7 - Bedside Upper Limb Functional Evaluation Tool will be assessed
Day 30 - Both outcomes will be assessed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/07/2024 |
| 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
|
Upon approval of the study plan , informed consent will be taken from the subject. A consent form for participation and taking a video recording of him/her while the scale is being administered will be taken. The BUFET scale will be administered on the subject on the first day of referral. The principal investigator (PI) will score the subject based on BUFET scale on the first day. The PI will score the subject again after a washout period of 7 days. Both scores will be used to establish intra-rater reliability. Four other raters ( 4 postgraduate students trained to administer the scale) will be used. The raters will be briefed about the BUFET scale following which they will score the subject based on the video recording of subject performing the activities. The scores of the 4 raters & the PI will be used to establish the inter-rater reliability. Wolf Motor Function Test (WMFT) scale will be administered along with BUFET on the first day of referral. Both the scales will again be administered on the subject after 1 month of duration. To establish the predictive validity, the initial score as well as the change in score of the BUFET scale will be compared with the initial score and change in score of the WMFT scale. |