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CTRI Number  CTRI/2024/09/074535 [Registered on: 30/09/2024] Trial Registered Prospectively
Last Modified On: 28/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Developing a New Device to Help Children Improve Neck Control, Balance and Walking Skill 
Scientific Title of Study   Designing and Developing Innovative Prototype Device to Improve Neck Control, Balance and Gait in Pediatric Population: Multiphasic Exploratory Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jenisha Jasmin Patalia 
Designation  Post Graduate Student 
Affiliation  RK University 
Address  Research Department, Room no. 207, School of Physiortherapy, RK University kasturbadham Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India. Rajkot GUJARAT 360020 India

Rajkot
GUJARAT
360020
India 
Phone  9909211451  
Fax    
Email  jpatalia430@rku.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Shrikant Savania 
Designation  Assistant Professor School of Physiotherapy RK University 
Affiliation  RK University 
Address  Research Department, Room no. 207, School of Physiortherapy, RK University kasturbadham Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India. Rajkot GUJARAT 360020 India

Rajkot
GUJARAT
360020
India 
Phone  8980748154  
Fax    
Email  shrikant.savaniya@rku.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Shrikant Savania 
Designation  Assistant Professor School of Physiotherapy RK University 
Affiliation  RK University 
Address  Research Department, Room no. 207, School of Physiortherapy, RK University kasturbadham Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India. Rajkot GUJARAT 360020 India

Rajkot
GUJARAT
360020
India 
Phone  8980748154  
Fax    
Email  shrikant.savaniya@rku.ac.in  
 
Source of Monetary or Material Support  
School of Physiotherapy, RK University, kasturbadham, Rajkot - Bhavnagar highway, Rajkot, Gujarat, India - 360020. 
 
Primary Sponsor  
Name  School of Physiotherapy RK University 
Address  School of Physiotherapy , RK University, Kasturbadham , Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India - 360020. 
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 
Dr Jenisha Jasmin Patalia  RK Physiotherapy Rehabilitation and Research center  Physiotherapy Department, Room no. 1, opp Meghani rang bhuvan,Bhaktinagar circle Rajkot, Gujarat, India. 360020
Rajkot
GUJARAT 		 09909211451

jpatalia430@rku.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, School of Physiotherapy, RK University,  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G939||Disorder of brain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not applicable  not applicable 
Intervention  Pediatric Neck control, balance and gait Enhancement Training  After developing the innovative device, we first conduct a pre-assessment of the patients. Then, give intervention 10 repetition, 3 set of activity according to the need and follow up after 2 weeks with a post-assessment. 
 
Inclusion Criteria  
Age From  3.00 Month(s)
Age To  7.00 Year(s)
Gender  Both 
Details  1) Pediatric patients aged 3 to 7 years.
2) Specific grading on the Pediatric Balance Scale (PBS) and apedal
3) Conditions affecting balance and gait: cerebral palsy, Developmental Coordination Disorder and related neurological, vestibular system or musculoskeletal disorders.
4) Able to perform assessments required for the study, including following simple instructions
5) Consent obtained from parents or legal guardians to participate in the study.
 
 
ExclusionCriteria 
Details  1) Children younger than 3 years or older than 7 years.
2) Acute Illness or Injury
3) Cognitive Impairments
4) Un-stable Medical Conditions
5) Recent surgery or trauma
6) Non-Consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Pediatric Balance Scale
2) Gross Motor Function Measure
 		 Pre outcome at Baseline (first day of training)
Post Outcome after 2 weeks(Last day of training)
 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 2 
Date of First Enrollment (India)   15/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/10/2024 
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 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 - NO
Brief Summary  
The current therapeutic solutions available for pediatric patients with balance and gait issues often fall short in terms of effectiveness, are subjective in nature, and tend to be expensive. These limitations have led to inconsistent therapeutic outcomes, creating a critical need for innovative approaches. This study introduces the development of an interactive prototype device specifically designed to address these gaps by enhancing neck control, balance and initiation gait in the pediatric population.

The proposed device aims to provide an engaging platform for therapeutic exercises through game-based interactions, making therapy both enjoyable and effective for children. With customizable options tailored to each patient’s specific needs, it also offers real-time feedback during therapy sessions. Furthermore, this device presents a more affordable alternative to existing solutions. Ultimately, the study seeks to transform the therapeutic experience for children by introducing a novel, motivating and interactive method to improve motor development and rehabilitation outcomes.
 
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