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CTRI Number  CTRI/2025/07/090973 [Registered on: 16/07/2025] Trial Registered Prospectively
Last Modified On: 15/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study to find out Immediate Effects of Icing, Continuous Stretching, and Brushing Techniques on Calf Muscle in Paralysis Subjects. 
Scientific Title of Study   A Study to Evaluate the Immediate effect of Cold Therapy, Sustained Stretching, and Brushing Therapeutic Techniques on Calf Muscle Spasticity in Stroke Subjects: A Randomized Control Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dharmik Gadher 
Designation  PG Scholar  
Affiliation  Faculty of Physiotherapy, Marwadi University 
Address  MB 557, Faculty of Physiotherapy, Marwadi University, Rajkot Morbi Highway, Gauridad, Rajkot, Gujarat, India - 360003

Rajkot
GUJARAT
360003
India 
Phone  8320987975  
Fax    
Email  dharmik.gadher123803@marwadiuniversity.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dharmik Gadher 
Designation  PG Scholar  
Affiliation  Faculty of Physiotherapy, Marwadi University 
Address  MB 557, Faculty of Physiotherapy, Marwadi University, Rajkot Morbi Highway, Gauridad, Rajkot, Gujarat, India - 360003

Rajkot
GUJARAT
360003
India 
Phone  8320987975  
Fax    
Email  dharmik.gadher123803@marwadiuniversity.ac.in  
 
Details of Contact Person
Public Query  
Name  Dharmik Gadher 
Designation  PG Scholar  
Affiliation  Faculty of Physiotherapy, Marwadi University 
Address  MB 557, Faculty of Physiotherapy, Marwadi University, Rajkot Morbi Highway, Gauridad, Rajkot, Gujarat, India - 360003

Rajkot
GUJARAT
360003
India 
Phone  8320987975  
Fax    
Email  dharmik.gadher123803@marwadiuniversity.ac.in  
 
Source of Monetary or Material Support  
MCS001, Physiotherapy OPD, Faculty of Physiotherapy, Marwadi University, Rajkot Morbi Highway, Gauridad, Rajkot, Gujarat, India - 360003 
 
Primary Sponsor  
Name  Dharmik Gadher 
Address  MB 557, Faculty of Physiotherapy, Marwadi University, Rajkot Morbi Highway, Rajkot. 
Type of Sponsor  Other [Self] 
 
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 Ashish Kakkad  Physiotherapy OPD  MCS001, Faculty of Physiotherapy, Marwadi University, Rajkot Morbi Highway, Gauridad, Rajkot, Gujarat, India - 360003
Rajkot
GUJARAT 		 9824415797

ashish.kakkad@marwadieducation.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Marwadi University Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G968||Other specified disorders of central nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Brushing Therapy  Brushing therapy will be applied to the spastic calf muscle for 20 minutes. The intervention includes using an electrical brush. The brush will be used to provide gentle, continuous stroking over the affected muscle. 
Intervention  Cold Therapy   Application of cold therapy over the spastic calf muscles for 20 minutes per session. The patient will be in a comfortable position, in the prone position, with the target leg supported.  
Comparator Agent  Standard Physiotherapy Exercise   Participants in the comparator group will receive standard physiotherapy exercises, including ankle toe movements and toe Raise Exercises. Each session will include 30 repetitions per exercise, performed in 2 sets, under the supervision of qualified physiotherapist.  
Intervention  Sustained Stretching   Sustained stretching of the spastic calf muscle will be given. Each stretch will be held for 30 seconds, repeated 3 times per session. Stretching will be done in a comfortable position under the supervision of a qualified physiotherapist.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subjects with a clinical diagnosis of stroke (ischemic or hemorrhagic) confirmed by an imaging technique (computed tomography or magnetic resonance imaging).
subacute and chronic phases of stroke. (Past stroke duration is 03 months to 02 years)
Presence of spasticity, as determined by Modified Ashworth Scale score of equal to or more than one.
Medically stable and able to participate in therapeutic interventions.
Subjects voluntarily agree to participate and provide informed consent. 
 
ExclusionCriteria 
Details  Epilepsy: individuals with a history of epilepsy or seizures.
Visual and auditory impairments.
Uncontrolled medical conditions.
Any other recent orthopedic and neurological condition.
Hypersensitivity or contraindication to any of the
therapeutic techniques. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Spasticity (H/M Ratio, Modified Ashworth Scale)
 		 Outcomes will be measured at Baseline and immediately after the intervention
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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="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    Stroke is a leading cause of disability worldwide, often resulting in spasticity, a condition characterized by increased muscle tone and exaggerated reflexes. Spasticity significantly affects the functional independence, quality of life, and rehabilitation outcomes of stroke survivors. Effective spasticity management is crucial to enable better motor control, reduce the risk of secondary complications, and improve participation in daily activities. Despite numerous therapeutic approaches available, there is limited consensus on their immediate effectiveness in reducing spasticity. Clinicians often face challenges in determining which intervention or combination of interventions provides optimal results for stroke survivors. A comparative evaluation of therapeutic techniques is essential to guide evidence-based clinical decision making.  
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