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CTRI Number  CTRI/2025/07/091656 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 03/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   How Instrument Assisted Soft Tissue Mobilization (IASTM) Instantly improves muscle flexibility and reduces spasticity in people with spastic Cerebral Palsy. 
Scientific Title of Study   Immediate effect of Instrument Assisted Soft Tissue Mobilization (IASTM) on Hamstring and Gastrocnemius flexibility and spasticity in individuals with spastic Cerebral Palsy (CP). 
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 Archana Gore 
Designation  Additional Professor 
Affiliation  Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai 
Address  402 Physiotherapy school and centre, Seth G.S.Medical College and KEM Hospital, OC building,E.Borges Road,opp.Tata Hospital , Parel,Mumbai, Maharashtra,400012,India.

Mumbai
MAHARASHTRA
400012
India 
Phone  9082621220  
Fax    
Email  nilarch17@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Pranali Redekar 
Designation  Student  
Affiliation  Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai 
Address  402 Physiotherapy school and centre, Seth G.S.Medical College and KEM Hospital, OC building,E.Borges Road,opp.Tata Hospital , Parel,Mumbai, Maharashtra,400012,India.

Mumbai
MAHARASHTRA
400012
India 
Phone  7021443366  
Fax    
Email  pranaliredekar06@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Archana Gore 
Designation  Additional Professor 
Affiliation  Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai 
Address  402 Physiotherapy school and centre, Seth G.S.Medical College and KEM Hospital, OC building,E.Borges Road,opp.Tata Hospital , Parel,Mumbai, Maharashtra,400012,India.

Mumbai
MAHARASHTRA
400012
India 
Phone  9082621220  
Fax    
Email  nilarch17@yahoo.co.in  
 
Source of Monetary or Material Support  
402 Physiotherapy school and centre, Seth G. S. Medical College and KEM Hospital, OC building, E. Borges Road, opp. Tata Hospital , Parel, Mumbai 400012, Maharashtra, India. 
 
Primary Sponsor  
Name  Dr. Pranali Redekar 
Address  402, Physiotherapy School and Centre, Seth G. S. Medical College and KEM Hospital, OC Building, E Borges Road, opposite Tata Hospital, Parel, Mumbai 
Type of Sponsor  Other [Self funded student study] 
 
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 Archana Gore  Physiotherapy School and Centre, Seth G. S. Medical College and KEM Hospital  Room No. 6, OPD No. 402, Physiotherapy School and Centre, Seth G. S. Medical College and KEM Hospital, OC Building, E Borges Road, opposite Tata Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA 
09082621220

nilarch17@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Seth G. S. Medical College and KEM Hospital, Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G809||Cerebral palsy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Instrument Assisted Soft Tissue Mobilization (IASTM)  Patient will be in prone position, with bilateral lower extremities in neutral position. Lubrication (Moisturizer) will be applied to the treatment area. Treatment duration will be 3-5 minutes for each spastic group of muscle. So the total duration for the intervention will vary from 5-15 minutes based on the number of spastic muscle group present in the patient (hamstring and gastrocnemius). A stainless-steel Graston tool will be used to give IASTM treatment. Treatment will be given in the form of 20-30 slow and long prolonged strokes; in the direction of muscle fibers, from origin to insertion, with the tool kept at 30-60 degree angle, for each spastic muscle (hamstring and gastrocnemius).  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Individuals diagnosed with spastic cerebral palsy with age above 4 years
2.MAS grading of hamstring & gastrocnemius between 1+ to 3 after routine antispastic medications. 
 
ExclusionCriteria 
Details  1.Severe tightness and contractures of hamstrings & gastrocnemius.
2.Skin infection over treatment area
3.Surgical history of lower limb within 6 months
4.Recent Botox injection within 6 months
5.Known case of epilepsy (uncontrolled)
6.Uncooperative patients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Modified Tardieu Scale (MTS),   Baseline (Pre intervention), Immediately after intervention on the same day  
 
Secondary Outcome  
Outcome  TimePoints 
Modified Ashworth Scale (MAS)   Baseline (Pre intervention), Immediately after intervention on the same day  
Goniometric PROM of knee and ankle  Baseline (Pre intervention), Immediately after intervention on the same day  
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   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 - NO
Brief Summary  
Cerebral Palsy (CP) is a neurological disorder caused by non-progressive brain malformation during fetal or infant development, leading to movement impairments, muscle weakness, and spasticity. Spastic CP is the most prevalent type, affecting nearly 75% of individuals with CP. Spasticity, characterized by increased muscle stiffness and resistance to passive stretching, often results in joint deformities, contractures, and restricted mobility, significantly affecting the quality of life. Managing spasticity remains a challenge for rehabilitation teams, requiring effective interventions to improve functional independence. Instrument-Assisted Soft Tissue Mobilization (IASTM) has gained attention as a non-invasive technique to enhance flexibility and reduce spasticity. It involves using specially designed tools to break down myofascial adhesions, stimulate fibroblast activity, and promote collagen remodeling, improving muscle function. While IASTM has shown promise in musculoskeletal conditions, research on its effects in CP remains limited, particularly regarding its immediate impact on spastic muscles. This study aims to evaluate the immediate effects of IASTM on hamstring and gastrocnemius flexibility and spasticity in individuals with spastic CP. The primary objective is to assess dynamic muscle length (R2-R1) before and after IASTM treatment using the Modified Tardieu Scale (MTS) and compare pre- and post-treatment values to determine its immediate effectiveness. This experimental pre-post study will be conducted at a tertiary healthcare center, involving individuals with spastic CP aged four years and above. Participants must have a Modified Ashworth Scale (MAS) grading of 1+ to 3 for the hamstring and gastrocnemius following routine anti-spastic medications. Exclusion criteria include severe contractures, recent botulinum toxin injections, lower limb surgeries, uncontrolled epilepsy, or skin infections over the treatment area. Ethical approval from the Institutional Ethics Committee (IEC) and Departmental Review Board (DRB) will be obtained before recruitment. Parents or guardians will receive detailed information about the study, and written informed consent will be collected. Pre-treatment assessment will include MAS grading for spasticity, MTS measurements for dynamic muscle length (R2-R1), and passive range of motion (PROM) measurements for knee flexion and ankle dorsiflexion using a goniometer. The IASTM treatment will be administered using a stainless-steel Graston tool, with slow, prolonged strokes applied along the muscle fibers from origin to insertion at a 30-60 degree angle for 2-3 minutes per muscle. Immediately post-treatment, reassessment of MAS grading, MTS measurements for dynamic muscle length, and goniometric PROM values will be conducted. Ice packs wrapped in a towel will be applied to the treatment area for 5-7 minutes to minimize potential soreness. The collected data will be analyzed to determine the effectiveness of IASTM in reducing spasticity and improving muscle flexibility. Given the limitations of current treatment methods, IASTM has the potential to serve as a non-invasive, cost-efficient approach to managing spasticity in CP. If proven beneficial, it could be integrated into rehabilitation programs, improving functional outcomes and mobility in individuals with CP.
 
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