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CTRI Number  CTRI/2025/11/096833 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 10/11/2025
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   Short-term effect of kinesio taping and Muscle Release Techniques on Ankle Movement and Muscle Tightness in Children with Spastic Cerebral Palsy 
Scientific Title of Study   Short-term effects of Kinesio taping and Myofascial release of Plantar flexors in Ankle ROM and Plantar flexor Hypertonicity among Children with spastic diplegic cerebral palsy: A randomized controlled 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  Jeemol p 
Designation  PG student  
Affiliation  Yenepoya Physiotherapy college  
Address  Yenepoya Physiotherapy college Ayush Campus Naringana Deralakatte Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8129362433  
Fax    
Email  34205@yenepoya.edu.in  
 
Details of Contact Person
Scientific Query  
Name  DrAsir John Samuel 
Designation  Additional professor  
Affiliation  Yenepoya Physiotherapy college  
Address  Yenepoya Physiotherapy college Ayush Campus Naringana Deralakatte Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8059930222  
Fax    
Email  asirjohnsamuel@yenepoya.edu.in  
 
Details of Contact Person
Public Query  
Name  DrAsir John Samuel 
Designation  Additional professor  
Affiliation  Yenepoya Physiotherapy college  
Address  Yenepoya Physiotherapy college Ayush Campus Naringana Deralakatte Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8059930222  
Fax    
Email  asirjohnsamuel@yenepoya.edu.in  
 
Source of Monetary or Material Support  
Yenepoya Physiotherapy College Ayush campus, Naringana, Deralakatte Mangalore - 575018 Karnataka State, India 
 
Primary Sponsor  
Name  Jeemol P 
Address  Yenepoya Physiotherapy college Yenepoya deemed to be University Mangalore 575018 
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 
DrAsir Jhon Samuel  Yenepoya medical college   Yenepoya Medical College Room 702 7th floor peadiatric department and its community centers Deralakatte Mangalore 575018.
Dakshina Kannada
KARNATAKA 		 8059930222

asirjohnsamuel@yenepoya.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yenepoya ethics committee-3  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G801||Spastic diplegic cerebral palsy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional physiotherapy   Stretching for the calf muscle  
Intervention  Kinesio taping and MFR   Kinesio tape application Prior to applying the tape the area will be assesses for skin texture any signs of allergic reactions and potential irritation. The treatment area (Calf) will be clean before the application of KT, Patient will be in supine lying. Separate Y strap will be prepared for each child. The calf muscle will be stretched to its maximum, and the distance from the Achilles tendon to the crease of the knee will be measured. The KT tape will then be cut according to the measured distance. The Y strap will be applied in the direction from insertion to origin, starting from the Achilles tendon to the origin of the soleus muscle and gastrocnemius. A minimal stretch will be applied to the KT tape during application. MFR Application MFR for the calf muscle will be performed with the patient in a prone position with a 120-second hold. During the technique, the finger pads will be applied to the central portion of the calf allowing them to sink in. The pressure will be maintained for 120 seconds to allow the tissue to soften after which the myofascial structures will be gently spread laterally until the first fascial barrier is felt.  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  Both genders will be included
Age group 3 –17
Clinical diagnosed with spastic diplegic cerebral palsy
Plantar flexor muscle tone in the score 1-3 in MAS 
 
ExclusionCriteria 
Details  Excluded the children who have frequent seizures
Patient who has deformities.
History of medical procedures that could impair motor functioning.
If any wounds, rashes, allergies, or edema were discovered in the lower limbs
Orthopedic correction surgery, or antispasmodic pharmaceutical
treatment were done. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Digital goniometer
 		 Measure before and after treatment in each sessions (1 week ,2 nd week )
 
 
Secondary Outcome  
Outcome  TimePoints 
MAS  will assess before & after treatment 2 day in a week for 2 weeks  
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   13/11/2025 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [34205@yenepoya.edu.in].

  6. For how long will this data be available start date provided 29-05-2025 and end date provided 28-05-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

TITLE OF THE RESEARCH TOPIC: Short-term effect of Kinesio taping and Myofascial release of Plantar flexors in Ankle ROM and Plantar flexor Hypertonicity among Children with spastic diplegic cerebral palsy: Quasi experimental study.

Spastic cerebral palsy causes motor impairments as well as abnormalities in the development of posture and movement. Compared to children who develop normally,children with SDCP experience developmental delays. One of the main problems in spastic

diplegic CP is spasticity of muscles especially on the calf muscle and that may result in restricted ROM of ankle. So, controlling spasticity is important, in this study we will be going to focus on the spasticity management of calf muscle. This study is expected to show

a decrease in plantar flexor tone and increase in Ankle ROM in children with SDCP by short-term use of MFR and Kinesio taping. MFR is expected to release restrictions in the deeper fascial layers, while KT is expected to offer sensory stimulation and muscular

assistance. This combination is expected to enhance conventional therapy by improving Ankle ROM along with decreasing muscle tightness.

This 1year quasi experimental study conducted at Yenepoya Hospital and its attached community centers will investigate the short-term effects of Kinesio Taping and Myofascial Release on plantar flexor muscle tone and ankle range of motion in 20 children aged 3-17 with spastic diplegic cerebral palsy, selected through purposive sampling, who meet specific inclusion criteria, including a diagnosis of spastic diplegic cerebral palsy and plantar flexor muscle tone score of 1-3 on the Modified Ashworth Scale, and exclude those with frequent seizures, deformities, certain medical procedures, wounds, or recent orthopedic surgery or antispasmodic medication.

 
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