FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/083642 [Registered on: 28/03/2025] Trial Registered Prospectively
Last Modified On: 25/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Effects of Reflex Mediated Postural Stabilization and Reflex Locomotion Adjunct to Conventional Physiotherapy on Motor Impairments in Children with Developmental Delay. 
Scientific Title of Study   Comparative Efficacy of Reflex Mediated Postural Stabilization and Reflex Locomotion with Adjunct to Conventional Physiotherapy on Motor Impairments in Children with Developmental Delay: A Parallel Three-Arm 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  Rutuja Sawalkar  
Designation  Junior Resident  
Affiliation  Ravi Nair Physiotherapy College  
Address  Paediatric Physiotherapy OPD and IPD 16 17 and 18 Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research Sawangi Wardha Maharashtra India
Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research Sawangi Wardha Maharashtra India 442001
Wardha
MAHARASHTRA
442001
India 
Phone  7218967108  
Fax    
Email  rutujasawalkar36@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neha Umale  
Designation  Associate Professor  
Affiliation  Ravi Nair Physiotherapy College  
Address  Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research Sawangi Wardha Maharashtra India

Wardha
MAHARASHTRA
442001
India 
Phone  9665682103  
Fax    
Email  umaleneha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sharath Hullumani 
Designation  Assistant Professor 
Affiliation  Ravi Nair Physiotherapy College  
Address  Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research Sawangi Wardha Maharashtra India

Wardha
MAHARASHTRA
442001
India 
Phone  8660621272  
Fax    
Email  sharathhullumani@gmail.com  
 
Source of Monetary or Material Support  
Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research Sawangi Wardha Maharashtra India 442001  
 
Primary Sponsor  
Name  Ravi Nair Physiotherapy College  
Address  Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research Sawangi Wardha Maharashtra India 442001 
Type of Sponsor  Research institution and hospital 
 
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 Rutuja Sawalkar   Acharya Vinoba Bhave Rural Hospital   Paediatric Physiotherapy OPD and IPD 16 17 and 18 Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research Sawangi Wardha Maharashtra India 442001
Wardha
MAHARASHTRA 		 7218967108

rutujasawalkar36@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research (DU)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F82||Specific developmental disorder ofmotor function,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Physiotherapy  1. Strength Training Stimulus: Use of toys and games to engage the child. Childs Position: Varied positions (sitting, standing). Therapist Position:Close to the child for support. Method: Incorporate playful activities that require pushing, pulling, and lifting to enhance muscle strength. Dosage: 20-30 minutes per session, 2-3 times a week. 2. Balance and Coordination Activities Stimulus: Fun balance games (e.g., standing on one leg). Childs Position: Standing or sitting on unstable surfaces (e.g., therapy balls). Therapist Position: Nearby for safety and support. Method: Encourage the child to perform tasks that challenge their balance and coordination. Dosage: 15-20 minutes per session 3. Functional Movement Activities Stimulus: Encourage crawling or walking movements through play. Childs Position: On hands and knees or standing with support. Therapist Position: Close by for encouragement and safety. Method: Integrate playful activities that motivate movement while applying conventional physiotherapy techniques to enhance coordination and mobility. Dosage: 3 sessions per week, 30 minutes each session. 
Intervention  Reflex Mediated Postural Stabilization  Side Lying Exercises Stimulus: Enhance lateral weight shifting and postural control. Childs Position: Side-lying on a mat. Therapist Position: Behind or in front of the child. Method: Apply pressure to stimulate lateral reflexes (Reflex Mediated Postural Stabilization), promoting balance and coordination. This Protocol is given for 4 weeks, 5 days per week for 30-40 minutes. 
Intervention  Reflex Locomotion   1. Supine Positioning Stimulus: Promote reaching and kicking movements. Childs Position: Supine on a mat. Therapist Position: At the childs feet, encouraging movement. Method: Use targeted pressure on the legs (Vojta Reflex rolling) to elicit coordinated movements. 4 times per day, 15-20 minutes 2. Prone Positioning Stimulus: Encourage head lifting and arm movements. Childs Position: Prone on a mat. Therapist Position: Beside the child, facilitating movement. Method: Apply pressure to specific zones on the back (Vojta Reflex rolling) to stimulate reflex locomotion. 4 times per day, 15-20 minutes This Protocol is given for 4 weeks, 5 days per week for 30-40 minutes. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  4.00 Year(s)
Gender  Both 
Details  Both male and female 
 
ExclusionCriteria 
Details  Seizures, severe ocular or mental disorders.
2. Any operational procedure within the last six months.
3. Children with pure language and social domain involvement.
4. Exclusive learning disabilities.
5. Medication affecting the experimental procedure.
6. Patients with any traumatic/musculoskeletal injury to lower limbs 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Gross Motor Function Measure (GMFM)  Baseline and 4th week 
 
Secondary Outcome  
Outcome  TimePoints 
1.Gross Motor Function Classification System (GMFCS)
2.Manual Ability Classification System (MACS) 		 Baseline & 4th week 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
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)   09/04/2025 
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 Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sharathhullumani@gmail.com].

  6. For how long will this data be available start date provided 16-03-2025 and end date provided 16-03-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   To determine the comparative efficacy of Reflex Mediated Postural Stabilization and Reflex Locomotion in adjunct to conventional physiotherapy on improving motor function in children with developmental delays.

To evaluate the comparative efficacy of Reflex Mediated Postural Stabilization and Reflex Locomotion in adjunct to conventional physiotherapy on improving motor function in children with developmental delays.

 
Close