| CTRI Number |
CTRI/2025/12/098350 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How movement-and-thinking tasks during sit-to-stand affect walking ability in people recovering from a recent stroke |
|
Scientific Title of Study
|
Correlation of motor and cognitive dual-task sit-to-stand on gait performance in individuals with subacute stroke - A cross-sectional 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 |
Ashmi R |
| Designation |
Post graduate in Neurology Physiotherapy |
| Affiliation |
KMCH College of Physiotherapy |
| Address |
MPT 2nd Year
KMCH College of Physiotherapy
Dr NGP Educational and Research Trust
Kalapatti Post
Coimbatore
Coimbatore
TAMIL NADU
641048
India |
| Phone |
7397334539 |
| Fax |
|
| Email |
ashmivimala13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alexander G |
| Designation |
Associate Professor |
| Affiliation |
KMCH College of Physiotherapy |
| Address |
KMCH College of Physiotherapy
Kalapatti Post
Coimbatore
Coimbatore
TAMIL NADU
641048
India |
| Phone |
7039745648 |
| Fax |
|
| Email |
alexdavid306@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Kannan |
| Designation |
Consultant Neurologist |
| Affiliation |
Kovai Medical Center and Hospital Limited |
| Address |
Kovai Medical Center and Hospital
99 Avinashi Road
Coimbatore
Coimbatore
TAMIL NADU
641014
India |
| Phone |
04224324298 |
| Fax |
|
| Email |
drkannanv@kmchhospitals.com |
|
|
Source of Monetary or Material Support
|
| KMCH college of Physiotherapy
Dr NGP educational and research trust
SF No 258 and 267 Kalapatti post
Coimbatore 641048
India |
|
|
Primary Sponsor
|
| Name |
KMCH college of Physiotherapy |
| Address |
KMCH college of Physiotherapy
Dr NGP educational and research trust
SF No 258 and 267 Kalapatti post
Coimbatore 641048
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ashmi R |
Kovai Medical Center and Hospital |
Department of Physiotherapy
Kovai Medical Center and Hospital
99 Avinashi Road
Coimbatore 641048
India
Coimbatore
TAMIL NADU |
7397334539
ashmivimala13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethics committee KMCH institute of allied health sciences |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subacute stroke Individuals in both men and women between the age of 45 to 65 years
First episode of Supratentorialstroke
Montreal Cognitive Assessment test score more than 26
Ability to walk 10 meters without walking aid
Patient able to hold an object (holding a 500 ml of water bottle) in the unaffected
side upper extremity
Ability to perform sit to stand activity independently for five times.
Individuals who are willing to participate in the study and have signed the consent form |
|
| ExclusionCriteria |
| Details |
Visual defects and Perceptual disorders
Neurological impairments except stroke which affect sit to stand and walking
Musculoskeletal impairments of lower extremity which affects sit to stand and walking
Aphasia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Sit to stand ability
2.Gait performance |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gait Parameters |
baseline |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
02/01/2026 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 cross sectional study aims to examine the correlation between sit to stand ability, measured using the Five Times Sit to Stand Test , and gait performance, assessed using the Figure of 8 Walk Test in individuals with subacute stroke. The study will evaluate how lower-limb functional strength and transitional mobility relate to dynamic gait control and turning ability. Findings are expected to help clinicians understand functional mobility limitations and guide targeted physiotherapy interventions during subacute stroke rehabilitation. |