| CTRI Number |
CTRI/2024/11/077504 [Registered on: 29/11/2024] Trial Registered Prospectively |
| Last Modified On: |
25/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effects of electrical stimulation on Tibialis anterior muscle to improve walking speed in stroke patients |
|
Scientific Title of Study
|
Immediate Effects of Tibialis Anterior Stimulation on Gait Velocity in Individuals 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 |
Birudu Vineetha |
| Designation |
Post Graduate Student |
| Affiliation |
Ramaiah College of Physiotherapy(RUAS) |
| Address |
Ramaiah medical college and Hospital Department of Physiotherapy 3 rd floor Ramaiah Nagara,MSRIT POST,Bangalore-560054
Banglore
KARNATAKA
560054
India
Bangalore
KARNATAKA
560054
India |
| Phone |
8309230801 |
| Fax |
|
| Email |
vineethabirudu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramesh Debur |
| Designation |
Associate Professor |
| Affiliation |
Ramaiah College of Physiotherapy(RUAS) |
| Address |
Ramaiah medical college and Hospital Department of Physiotherapy 3 rd floor Ramaiah Nagara,MSRIT POST,Bangalore-560054Bangalore
KARNATAKA
560054
India
Bangalore
KARNATAKA
560054
India |
| Phone |
9845544848 |
| Fax |
|
| Email |
rameshdebur.rcp@msruas.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Ramesh Debur |
| Designation |
Associate Professor |
| Affiliation |
Ramaiah College of Physiotherapy(RUAS) |
| Address |
Ramaiah medical college and Hospital Department of Physiotherapy 3 rd floor Ramaiah Nagara,MSRIT POST,Bangalore-560054
Bangalore
KARNATAKA
560054
India
Bangalore
KARNATAKA
560054
India |
| Phone |
9845544848 |
| Fax |
|
| Email |
rameshdebur.rcp@msruas.ac.in |
|
|
Source of Monetary or Material Support
|
| Ramaiah Memorial Hospital, M S Ramaiah Nagara, MSRIT Post,
Bangalore-560054 |
|
|
Primary Sponsor
|
| Name |
Birudu Vineetha |
| Address |
Ramaiah College of Physiotherapy, M S Ramaiah Nagara, MSRIT Post,
Bangalore-560054 |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Birudu Vineetha |
Ramaiah Medical College and Hospitals |
M S Ramaiah Nagara MSRIT Post
Bangalore 560054
Bangalore
KARNATAKA |
8309230801
vineethabirudu@gmail.com |
| Birudu Vineetha |
Ramaiah College of Physiotherapy |
M S Ramaiah Nagara MSRIT Post Bangalore 560054 Karnataka
Bangalore
KARNATAKA |
8309230801
vineethabirudu@gmail.com |
| Birudu Vineetha |
Ramaiah Memorial Hospital |
M S Ramaiah Nagara MSRIT Post
Bangalore 560054
Bangalore
KARNATAKA |
8309230801
vineethabirudu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ramaiah Medical College and Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G89-G99||Other disorders of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kotz Current |
Participant will be comfortably seated on a chair with legs supported. Tibialis anterior will be palpated by locating the tibial tuberosity and fibular head, moving fingers down to find the muscle belly. First electrode will be placed vertically here.
Second electrode will be placed 2/3 down the shin, aligned toward the midline.
Kotz current electrical stimulation will be given with set parameters.
Immediately post-intervention, gait velocity will be measured using GAITRite |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Participants with stroke( more than 3 months )
Fugel meyer lower limb score below 21
Participants who can walk independently |
|
| ExclusionCriteria |
| Details |
Other orthopedic or neurological conditions interfering with gait function.
Unstable medical conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gait Velocity |
Pre-stimulation:Measuring gait velocity before applying tibialis anterior stimulation
Post-stimulation:Measuring gait velocity immediately after the stimulation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
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)
|
11/12/2024 |
| 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 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 aims to evaluate the effects of Kotz (Russian) stimulation on the tibialis anterior (TA) muscle in chronic stroke patients to improve gait mechanics, specifically targeting TA muscle activation patterns essential for gait. Stroke is a leading cause of death and disability globally, with a significant burden in India. Impairments in gait, such as decreased stance phase, prolonged swing phase, reduced walking speed, and decreased stride length, heighten fall risk and compromise independence in stroke survivors. The tibialis anterior muscle plays a crucial role in ankle dorsiflexion for foot clearance and placement during the gait cycle, yet stroke often disrupts muscle activation patterns, increasing fall susceptibility. Kotz stimulation has shown positive effects on the motor system in neurological patients, enhancing postural stability and gait. This study seeks to determine the therapeutic efficacy of Kotz stimulation on TA muscle activation, aiming to improve gait performance and functional outcomes in chronic stroke patients. |