| 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
|
|
|
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
|
|
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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 |
|
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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. |