| CTRI Number |
CTRI/2025/09/094313 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
06/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Correlation study |
| Study Design |
Other |
|
Public Title of Study
|
How Balance and Leg Coordination Affect Walking Speed in People with Chronic Stroke
|
|
Scientific Title of Study
|
Impact of balance and lower limb coordination on immediate walking speed in patients with chronic stroke:
A Correlation 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 |
Aswathi P V |
| Designation |
Post graduate student |
| Affiliation |
Yenepoya physiotherapy college |
| Address |
Yenepoya medical college hospital, physiotherapy department 7th floor, OPD, Neuroward 5th floor, university road ,Deralakatte,Mangaluru,Karnataka,India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8606426858 |
| Fax |
|
| Email |
aswathipv812@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shifali |
| Designation |
Assistant professor |
| Affiliation |
Yenepoya physiotherapy college |
| Address |
Yenepoya physiotherapy college,6th floor, Naringana, Mangalore-575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9353899352 |
| Fax |
|
| Email |
shifalikotian@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Shifali |
| Designation |
Assistant professor |
| Affiliation |
Yenepoya physiotherapy college |
| Address |
Yenepoya physiotherapy college,6th floor, Naringana, Mangalore-575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9353899352 |
| Fax |
|
| Email |
shifalikotian@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Yenepoya (Deemed to be university)Yenepoya physiotherapy college,6th floor, Naringana, Mangalore,India-575018 |
|
|
Primary Sponsor
|
| Name |
Aswathi P V |
| Address |
Yenepoya physiotherapy college, university road, dertakatte, mangaluru, Dakshina Kannada Karnataka,India-575018 |
| Type of Sponsor |
Other [Self] |
|
|
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 Aswathi P V |
Yenepoya (Deemed to be university) |
Yenepoya medical college hospital, physiotherapy department 7th floor, OPD, Neuroward 5th floor, university road ,Deralakatte,Mangaluru,Karnataka,India
Dakshina Kannada
KARNATAKA |
8606426858
aswathipv812@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee 3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I629||Nontraumatic intracranial hemorrhage, 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 |
a)Stroke atleast 6 month before the study participation
b)Participants must between 18 and 85 year old
c)Participant must able to walk independently
d)Patient able to follow verbal instructions
e)Effected side were graded 4/5 in the manual muscle testing |
|
| ExclusionCriteria |
| Details |
a)Individual with sever cognitive impairment based on mini mental state exmination 18/19 for individual with literacy and 24/25 for those with basic education
b)Participants with sever motor impairment
c)Patients with unstable vitals and other illness (cardiac issues, hypertension ) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
10 meterwalk test
Berg balance scale
Lowerlimb motor coordination test
|
8 Points
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
20/09/2025 |
| 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 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 study investigates how balance and lower limb coordination impact the immediate walking speed of chronic stroke patients. Stroke-related motor impairments often lead to gait dysfunction, making it crucial to understand the relationship between these factors. Using clinical balance tests, coordination assessments, and a 10-meter walk test, the study aims to determine whether better balance and coordination correlate with faster walking speeds. Findings could help refine rehabilitation strategies by emphasizing balance and coordination training to improve mobility outcomes in stroke survivors |