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CTRI Number  CTRI/2026/03/105368 [Registered on: 05/03/2026] Trial Registered Prospectively
Last Modified On: 04/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Ultrasonographic Features versus Clinical Grading of Spasticity 
Scientific Title of Study   Correlational analysis of ultrasonographical features and clinical parameters of spasticity 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Fiyanshu Satyavna 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences Jodhpur 
Address  Physical Medicine & Rehabilitation Department, All India Institute of Medical Sciences Jodhpur, Basni Industrial Area Phase 2, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  7239900327  
Fax    
Email  fiyanshusatyavna@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nitesh M Gonnade 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences Jodhpur 
Address  Physical Medicine & Rehabilitation Department, All India Institute of Medical Sciences Jodhpur, Basni Industrial Area Phase 2, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone    
Fax    
Email  drniteshgonnade9@gmail.com  
 
Details of Contact Person
Public Query  
Name  Fiyanshu Satyavna 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences Jodhpur 
Address  Physical Medicine & Rehabilitation Department, All India Institute of Medical Sciences Jodhpur, Basni Industrial Area Phase 2, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  7239900327  
Fax    
Email  fiyanshusatyavna@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Jodhpur 
Address  All India Institute of Medical Sciences, Jodhpur Basni Industrial Area Phase 2, Jodhpur 342005 Rajasthan 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Fiyanshu Satyavna  All India Institute of Medical Sciences, Jodhpur  All India Institute of Medical Sciences, Jodhpur Basni Industrial Area Phase 2, Jodhpur
Jodhpur
RAJASTHAN 		 7239900327

fiyanshusatyavna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee All India Institute of Medical Sciences, Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I693||Sequelae of cerebral infarction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Confirmed stroke
Presence of clinical spasticity Modified Ashworth Scale 1 to 3 in at least one upper or lower limb on paretic side
Household ambulator with or without assistive devices
Able to provide informed consent 
 
ExclusionCriteria 
Details  Cognitive impairment Mini-Cog less than 3 or MOCA less than 18
Recurrent stroke or bilateral limb involvement
Medical instability or pregnancy
History of interventional procedure for spasticity management
Pre-existing neuromuscular or musculoskeletal disorders affecting limb function like muscular dystrophy, neuropathies
Fixed contractures in the affected limb 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare ultrasound-measured echogenic intensity via Modified Heckmatt Scale findings with clinical spasticity grading using Modified Ashworth Score of biceps brachialis, pronator teres, gastrocnemius, soleus and in paretic limbs of stroke survivors  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To compare structural changes in ultrasonographical findings & functional performance via Fugl-Meyer Motor Assessment , Timed Up & Go test, 6-Metre Walk Test & grip strength  Baseline 
To quantify & compare key ultrasonographic structural parameters including echogenic intensity, circumference, pennation angle & muscle thickness with clinical spasticity grading using Modified Ashworth Score between selected paretic & non-paretic muscles in upper & lower limbs of stroke survivors  Baseline 
To measure muscle stiffness in spastic muscles using Shear wave Elastography compare these measurements with clinical spasticity grading using Modified Ashworth Score in stroke survivors  Baseline 
 
Target Sample Size   Total Sample Size="69"
Sample Size from India="69" 
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)   16/03/2026 
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="2"
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   Spasticity in stroke survivors is a chronic complication associated with functional impairment and disability. It leads to significant alterations in muscle architecture. Ultrasound is a non invasive and reliable tool for assessing such muscular changes. This proposed study is an observational cross sectional correlational analysis. The core purpose of which is to bridge the gap between subjective clinical spasticity assessments and objective structural muscle changes associated with spasticity.
This will be an observational cross sectional study to be conducted at Physical Medicine and Rehabilitation Department of AIIMS Jodhpur. After approval by Institutional Ethics Committee and informed consent of participants, stroke survivors will be subjected to detailed screening, comprehensive clinical and functional assessments, and advanced multimodal ultrasonographic imaging.
Setting will be  Subjects would typically be recruited from outpatient or inpatient unit of Physical Medicine and Rehabilitation department . All clinical and ultrasound assessments will be performed after recruitment by radiologist or PMR specialist with 10 years experience in musculoskeletal ultrasonography.
Control Mechanism is The unaffected nonparetic limb of primary stroke survivor will be used as the control for comparing muscle properties, as individual factors like age, sex, and systemic factors are the same for both sides.

 
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