| CTRI Number |
CTRI/2025/05/087799 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
06/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Checking the GDLAM Protocol can be used to measure how well participants being stroke survivors living at home can take care of themselves and do daily activities on their own by relating it with barthel index scores
|
|
Scientific Title of Study
|
Evaluating Group of Latin-American Development for Maturity (GDLAM) Protocol Validity for Functional Autonomy among Community Dwelling Stroke Survivors: A Correlation Study with the Barthel Index |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Royd Brian Dsouza |
| Designation |
Mater of Physiotherapy - Neurological Sciences |
| Affiliation |
FATHER MULLER COLLEGE OF PHYSIOTHERAPY |
| Address |
Father Muller medical College hospital
R WARD 3rd floor Department of Rehabilitative medicine
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
7760009642 |
| Fax |
|
| Email |
roydbrian01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K M Garima Gupta |
| Designation |
Professor of MPT in Neurological Sciences |
| Affiliation |
FATHER MULLER COLLEGE OF PHYSIOTHERAPY |
| Address |
Father Muller medical College hospital
R WARD 3rd floor Department of Rehabilitative medicine
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
7897044180 |
| Fax |
|
| Email |
garima.gupta@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Royd Brian Dsouza |
| Designation |
Mater of Physiotherapy - Neurological Sciences |
| Affiliation |
FATHER MULLER COLLEGE OF PHYSIOTHERAPY |
| Address |
Father Muller medical College hospital
R WARD 3rd floor Department of Rehabilitative medicine
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
7760009642 |
| Fax |
|
| Email |
roydbrian01@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Father Muller College of Physiotherapy |
| Address |
Father Muller College of Physiotherapy,
575002 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Royd Brian Dsouza |
Father Muller Medical College Hospital |
Department of physiotherapy
-2 floor Asha Kian block
number 10
Dakshina Kannada
KARNATAKA |
7760009642
roydbrian01@gmail.com |
| Royd Brian Dsouza |
Father Muller Medical College Hospital general ward |
R WARD 3rd floor
Department of Rehabilitative medicine
Dakshina Kannada
KARNATAKA |
7760009642
roydbrian01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| FATHER MULLER INSTITUTIONAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
STROKE |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Age more than or equal to 18 years, both male and female
2 Community dwelling Stroke survivors
3 Type of Stroke- Ischemic Stroke or Hemorrhagic Stroke
4 Hemi paretic or hemiplegic stroke survivors
5 Modified Rankin scale (mRS) less than or equal to 3
6 Ability to understand and follow simple commands
Participant with functional vision and hearing |
|
| ExclusionCriteria |
| Details |
1 Any other medically diagnosed neurological condition apart from stroke
2 Acute or Chronic Pain /Illness / Injury which may interfere with testing
3 Any musculoskeletal, or cardiovascular disorder that may interfere with testing
4 Congenital deformities that may affect ambulation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
GDLAM protocol
Barthel index
|
One time data collection on same day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
15/06/2025 |
| 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
Modification(s)
|
In India, stroke is among the main reasons for death and disability. Most individuals with stroke are suffering from reduced autonomy as a result of difficulties carrying out activities of daily living. The ability to perform everyday tasks independently is known as Functional Autonomy. Various valid and reliable tools such as Barthel Index (BI), Stroke Impact Scale (SIS), and Functional Independence Measure (FIM) scale are available to assess functional independence among stroke patients. Barthel index is one of the most widely used tool to assess ADL performance in stroke patients. Though it is valid and reliable measure, the scoring of this tool is semi-objective, and the weights attributed to each items are arbitrary. Hence there is need to establish the validity of functional measure which is objective in nature and covers most of the components of functional independence. Group of Latin-American Development for Maturity (GDLAM) protocol is an objective measure to measure functional autonomy consisting of five functional tests. All items are measured in seconds and this protocol provides a composite score of functional independence as “Functional autonomy index (GI)”. Though this protocol is widely used but original author of this protocol have only established its reliability and face validity. Hence there is a need to establish its validity. RESEARCH QUESTION: What is the construct validity of GDLAM protocol among community dwelling stroke survivors? |