| CTRI Number |
CTRI/2026/04/109141 [Registered on: 23/04/2026] Trial Registered Prospectively |
| Last Modified On: |
21/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship of Calf Muscle Tightness and Tibialis Anterior Function with Balance in Chronic Stroke Patients |
|
Scientific Title of Study
|
Impact of Calf Muscle Spasticity and Tibialis Anterior Muscle Recruitment On Balance In Individual With Chronic 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 |
Urvi Parmar |
| Designation |
PG Student |
| Affiliation |
S.S. agrawal institute of physiotherapy and medical care education, navsari. |
| Address |
Neuro Out Patient Department, Ground Floor, S.S. Agrawal Institute Of Physiotherapy, Agrawal College Campus, Verranjali Marg 1 , Devina
Park, Navsari.
Navsari
GUJARAT
396445
India |
| Phone |
7046035010 |
| Fax |
|
| Email |
urvip114@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jagruti Patel |
| Designation |
I/C Principal, PHD , PG Guide |
| Affiliation |
S.S. agrawal institute of physiotherapy and medical care education, navsari. |
| Address |
Neuro Out Patient Department, Ground Floor, S.S. Agrawal Institute Of Physiotherapy, Agrawal College Campus, Verranjali Marg 1 , Devina
Park, Navsari.
Navsari
GUJARAT
396445
India |
| Phone |
9974661767 |
| Fax |
|
| Email |
jagukpatel57@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jagruti Patel |
| Designation |
I/C Principal, PHD , PG Guide |
| Affiliation |
S.S. agrawal institute of physiotherapy and medical care education, navsari. |
| Address |
Neuro Out Patient Department, Ground Floor, S.S. Agrawal Institute Of Physiotherapy, Agrawal College Campus, Verranjali Marg 1 , Devina
Park, Navsari.
GUJARAT
396445
India |
| Phone |
9974661767 |
| Fax |
|
| Email |
jagukpatel57@gmail.com |
|
|
Source of Monetary or Material Support
|
| S S Agrawal Institute of Physiotherapy and Medical Care education , Navsari , Gujarat, 396445
agrawal college campus , out patient department , veeranjali marg , devina park , navsari |
|
|
Primary Sponsor
|
| Name |
Urvi Parmar |
| Address |
At.Post Zervavra,Sutharwad, Ta:Mahuva, Dis: Surat, Gujarat,India, 394245 |
| 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 Jagruti Patel |
S S Agrawal Institute of physiotherapy And Medical Care Education , Navsari |
Department of
physiotherapy ,
Ground Floor ,
Agrawal College
Campus, Viranjali
Marg .Devina Park
,Navsari , Gujarat
Navsari, GUJARAT
Navsari
GUJARAT |
9974661767
jagukpatel57@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC),S S Agrawal Institute Of Physiotherapy And Medical Care education . Navsari |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G93||Other disorders of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
A study population may include patients experiencing a first-ever unilateral stroke, whether hemorrhagic or ischemic, with a duration of at least six months. Eligible participants are aged between 35 and 65 years and have been clinically diagnosed with either type of stroke. Additionally, they should present with calf muscle spasticity of grade 1 or higher as measured by the Modified Ashworth Scale (MAS). Participants must be able to understand and follow commands, indicating adequate cognitive function, which is confirmed by a score of 24 or above on the Mini-Mental State Examination (MMSE). Furthermore, individuals should have achieved at least stage 3 on the Brunnstrom Motor Recovery Scale for the lower limb. |
|
| ExclusionCriteria |
| Details |
Participants were excluded if they had visual impairments or depression. Individuals with cognitive disorders that made them unable to understand or follow the examiner’s instructions were also not included. Additionally, patients with musculoskeletal conditions affecting the lower limbs—such as contractures, fractures, or severe arthritis—were excluded. Those who had received a botulinum toxin injection in the calf muscle within the past three months were also not considered eligible for participation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
MMSE Scale
MAS
MINIBEST Scale
RMS |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NIL |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
03/05/2026 |
| 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="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
|
AIM: To investigate the impact of calf muscle spasticity and tibialis anterior muscle recruitment on balance control among individuals with chronic stroke.
OBJECTIVE: To assess the degree of calf muscle spasticity in individuals with chronic stroke.
To evaluate the activation of the tibialis anterior muscle in individuals with chronic stroke.
To determine the relationship between calf muscle spasticity and balance performance.
To determine the relationship between tibialis anterior muscle recruitment and balance performance.
To compare the extent to which calf muscle spasticity and tibialis anterior muscle recruitment affect balance control.
|