| CTRI Number |
CTRI/2026/02/104911 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
26/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Whole Body Vibration in Children with Spastic Cerebral Palsy |
|
Scientific Title of Study
|
Immediate Change in Gait Pattern Following Single Session Whole Body Vibration Treatment in Children with Spastic Cerebral Palsy |
| 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. Gargi Untawale (PT) |
| Designation |
Postgraduate Student |
| Affiliation |
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
| Address |
Room no. 21, Department of Physiotherapy,
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan)
4, Vishnu Digamber Marg, New Delhi,India
Pin- 110002
Central
DELHI
110002
India |
| Phone |
9009334207 |
| Fax |
|
| Email |
untawale.gargi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Manda Chauhan (PT) |
| Designation |
Associate Professor and HOD (PT) |
| Affiliation |
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
| Address |
Room no. 209, Department of Physiotherapy,
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan)
4, Vishnu Digamber Marg, New Delhi,India
Pin- 110002
Central
DELHI
110002
India |
| Phone |
9911152994 |
| Fax |
|
| Email |
physiotherapypduiph@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Pradeep Marandi (PT) |
| Designation |
Superintendent (PT) |
| Affiliation |
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
| Address |
Room no. 21, Department of Physiotherapy,
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan)
4, Vishnu Digamber Marg, New Delhi,India
Pin- 110002
Central
DELHI
110002
India |
| Phone |
9818198990 |
| Fax |
|
| Email |
pradeep.marandi@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
|
|
Primary Sponsor
|
| Name |
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities Divyangjan |
| Address |
Department of Physiotherapy,
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan)
4, Vishnu Digamber Marg, New Delhi,India
Pin- 110002 |
| Type of Sponsor |
Other [Rehabilitation and Academic Institute] |
|
|
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 Gargi Untawale PT |
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
Room no. 21, Department of Physiotherapy, 4, Vishnu Digamber Marg, New Delhi, 110002
Central
DELHI |
9009334207
untawale.gargi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G801||Spastic diplegic cerebral palsy, (2) ICD-10 Condition: G802||Spastic hemiplegic cerebral palsy, (3) ICD-10 Condition: G800||Spastic quadriplegic cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
N/A |
| Intervention |
Whole Body Vibration |
A single session of SOBO Crazy Fit Massage WBV platform vibrator will be used to deliver side-alternating WBV of frequency 50-60Hz.
All participants will complete six bouts of vibration, with each bout involving 60s of vibration and 60s of rest. Participants will stand bare feet on the platform with knees partially flexed. Since this study will observe the effect of single session participants will undergo treatment for one time with total duration of treatment being 12 mins for the given session. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children with clinically confirmed diagnosis of spastic cerebral palsy.
2. 6 years to 12 years of age of both gender.
3. GMFCS level I, II, and III.
4. Those who are able to walk without an assistive device for eight meters.
5. Those who are able to stand with or without holding a hand rail for ten minutes.
6. Those who are able to understand verbal instructions and follow command.
|
|
| ExclusionCriteria |
| Details |
1. Those with history of any surgical procedure for the management of spasticity.
2. Those who have taken botulinum toxin injections in past 6 months.
3. Those who are currently on any anti-spastic medication.
4. Those using baclofen pump
5. Children fearful of platform vibrator (intervention modality)
6. Those who have already developed contractures.
7. Children with any of a following associated condition- acute thrombosis, serious cardiovascular disease, pacemaker, recent wounds from trauma or surgery, hip or knee implants, acute hernia, discopathy, spondylosis, sever diabetes, epilepsy, recent infection, severe migraine, tumors, metal pins or plates, renal stones, organ failure.
8. Any other progressive neurological, metabolic, or balance disorders not typically associated with CP.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Modified Ashworth Scale
2. Edinburgh Visual Gait Score |
1.Baseline
2.Immediate post intervention
3.Next day of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Walking Velocity |
1.Baseline
2.Immediate post intervention
3.Next day of intervention |
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
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)
|
10/03/2026 |
| 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="0"
Months="6"
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
|
Background: Spasticity is one of major cause of deviation from normal gait pattern in children with spastic cerebral palsy. Recently whole body vibration (WBV) has gained popularity as a non invasive treatment for spasticity. We are attempting to investigate change in gait pattern in children with spastic CP following single session of side-alternating WBV and its carryover effect until next day of treatment. Our hypothesis is that change in gait pattern will be due to change in muscle tone. Methods: Children with spastic CP aged 6–12 years at GMFCS level I-III will participate in this study. Participants will receive a single session of side-alternating WBV with frequency 50-60 Hz. The session will include six bouts of 60s of WBV and 60s of rest. Assessment will be done three times- (a) Before WBV, (b) Immediately after WBV, (c) After 24 hrs of WBV. Following measurement tools will be used to assess effects of intervention- (a) Modified Ashworth Scale, (b) Edinburgh Visual Gait Score, (c) Walking velocity. Keywords: Cerebral Palsy, Gait, Spasticity, Walking velocity, Whole Body Vibration |