| CTRI Number |
CTRI/2025/07/091347 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparative study on the use of Kinesio Taping and Sham Taping to improve foot movement during walking and reduce fall risk in recovering stroke patients using video analysis and walking test. |
|
Scientific Title of Study
|
Effects of Kinesio Taping on mid swing dorsiflexion angle and fall risk in subacute and chronic stroke patients: A Comparative 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 |
Dr Ayushi Parmar PT |
| Designation |
First Year Master of Physiotherapy resident |
| Affiliation |
Government Physiotherapy college, Jamnagar |
| Address |
Neuromuscular rehabilitation department, Government Physiotherapy College, Old TB hospital building, Near Government Dental college, Rameshwar Nagar, Jamnagar.
Jamnagar
GUJARAT
361008
India |
| Phone |
9925569761 |
| Fax |
|
| Email |
ayushiparmar5098@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karishma Jagad |
| Designation |
Master of Physiotherapy in Neurological condition |
| Affiliation |
Government Physiotherapy college, Jamnagar |
| Address |
Government Physiotherapy College, Old TB hospital building, Near Government Dental college, Rameshwar Nagar, Jamnagar.
Jamnagar
GUJARAT
361008
India |
| Phone |
9374141991 |
| Fax |
|
| Email |
karishma.jagad@gptcjam.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ayushi Parmar |
| Designation |
First Year Master of Physiotherapy resident |
| Affiliation |
Government Physiotherapy college, Jamnagar |
| Address |
Government Physiotherapy College, Old TB hospital building, Near Government Dental college, Rameshwar Nagar, Jamnagar.
Jamnagar
GUJARAT
361008
India |
| Phone |
9925569761 |
| Fax |
|
| Email |
ayushiparmar5098@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neurological Rehabilitation OPD, Government Physiotherapy college, Old TB Hospital Building, Near dental College, Rameshwar Nagar, Jamnagar,361008, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Government Physiotherapy College jamnagar |
| Address |
Old TB hospital, Near dental college, Rameshwar Nagar, Jamnagar, 361008, Gujarat, India |
| Type of Sponsor |
Government medical college |
|
|
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 Ayushi Parmar |
Government Physiotherapy College |
Neuromuscular rehabilitation department at Government Physiotherapy college, Jamnagar
Jamnagar
GUJARAT |
9925569761
ayushiparmar5098@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee M. P. Shah Govt. Medical College and Guru Gobindsingh Hospital,Jamnagar |
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 |
Kinesio taping |
In this study I will be applying Kinesio Taping for Tibialis Anterior which is prime movers muscle for dorsiflexion and taking baseline data Before Kinesio taping and immediate after Kinesio taping intervention and after 24 hours of Kinesio taping intervention |
| Comparator Agent |
Sham Taping |
In this study I will be applying Sham Taping for Tibialis Anterior which is prime movers muscle for dorsiflexion and taking baseline data Before Sham taping and immediate after Sham taping intervention and after 24 hours of Sham taping intervention |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects willing to participate in the study. Hemiplegia due to hemorrhagic or ischemic stroke more than 3 months. Able to walk independently for over 10 m with or without assistive devices. Modified Ashworth Scale score lower than 3 in planter flexors. Insufficient ankle dorsiflexion during the swing phase of the gait cycle.
|
|
| ExclusionCriteria |
| Details |
A premorbid or current orthopedic problem involving the lower extremities. A known congenital abnormality of the nervous system. Medical condition like uncontrolled diabetes and herpes zoster. Severe cardio-pulmonary disease that limiting gait ability.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EXAMINE DORSIFLEXION ANGLE WITH KINOVEA SOFTWARE |
Immediate after taping and 24 hours after taping |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time up and Go Test |
Immediate after taping and 24 hours after taping |
|
|
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)
|
01/08/2025 |
| 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="0"
Months="8"
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 - YES
- What data in particular will be shared?
Response (Others) -
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response (Others) -
- For what types of analyses will this data be available?
Response (Others) -
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 15-08-2026 and end date provided 15-08-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Data will be collected from government physiotherapy college Jamnagar, outpatient department of neuromuscular rehabilitation. After collecting data , extraction of total number of patient visiting for the treatment will be done. Patients who fit for inclusion criteria will be selected. consent of patient will be taken. then all the patients divided in two groups. one group get kinesio taping to tibialis anterior muscle and other group get sham taping for tibialis anterior muscle along with conventional physiotherapy. Dorsiflexion angle from kinovea software and TUG test will taken before taping intervention as baseline data and after immediate and after 24 hours of taping treatment. then comparison of the results will be done and conclusion will be made. |