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CTRI Number  CTRI/2023/03/050826 [Registered on: 20/03/2023] Trial Registered Prospectively
Last Modified On: 18/03/2023
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   comparison between motor dual task training and cognitive dual task training on balance in children with cerebral palsy 
Scientific Title of Study   Comparative effectiveness of motor dual task training and cognitive dual task training on balance in children with cerebral palsy  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  devan 
Designation  physiotherapy 
Affiliation  indian spinal injury centre  
Address  indian spinal injury centre vasant kunj delhi

New Delhi
DELHI
110070
India 
Phone  8383936478  
Fax    
Email  devankashyap98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  garima wadhwa 
Designation  physiotherapy 
Affiliation  Indian spinal injury center 
Address  physiotherapy department , 2nd floor
physiotherapy department , 2nd floor
New Delhi
DELHI
110070
India 
Phone  9650086472  
Fax    
Email  garimawdhw@gmail.com  
 
Details of Contact Person
Public Query
 
Name  garima wadhwa 
Designation  physiotherapy 
Affiliation  Indian spinal injury center 
Address  physiotherapy department , 2nd floor
physiotherapy department 2nd floor
New Delhi
DELHI
110070
India 
Phone  9650086472  
Fax    
Email  garimawdhw@gmail.com  
 
Source of Monetary or Material Support  
INDIAN SPINAL INJURY CENTRE, Sector C , vasant kunj , new delhi  
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [no sponsors] 
 
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 
devan  Indian Spinal Injury Center  Rehabilitation Departement Sector C , vasant kunj second floor, admin office, room no. 1 New Delhi DELHI
New Delhi
DELHI 
8383936478

devankashyap98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
devan kashyap  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  cognitive task training  4 weeks 
Intervention  dual motor task training  4 weeks 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Stand independently for at least 30 seconds.
2.Walk independently with or without an assistive device
3.Understand protocol and parents give informed consent.
4.Gross motor functional measure I and II. 
 
ExclusionCriteria 
Details  1.Children, who are uncooperative
2.Have history of epilepsy
3.With hearing, visual and speech deficit
4.Any cardiac anomalies affecting exercise tolerance. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
gross motor function measure  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
functional reach test  4 weeks 
peadiatric balance scale  4 weeks 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   20/03/2023 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The aim of this research is to find the effectiveness of motor dual task training and cognitive dual task training in children with cerebral palsy to improve balance in children and reduce their incidence of fall.

Cerebral palsy (CP) is a group of disorders that affect a person’s ability to move and maintain balance and posture. CP is the most common motor disability in childhood. CP is caused by abnormal brain development or damage to the developing brain that affects a person’s ability to control his or her muscles.

The prevalence of CP has risen to well above 2.0 per 1000 live births. In this time span the proportion of low-birthweight infants rose, the proportion of diplegia decreased, while the proportion of hemiplegia increased. CP is more prevalent in more deprived socio-economic populations. The majority of people with CP have the spastic syndrome of which the diplegic group is the smallest. Dependent on the subgroup of CP, 25 – 80% have additional impairments.

According to Karolina et al (2020) patient receiving dual task training have improved balance and functional mobility children with spastic diplegic cerebral palsy have improved significantly in the course of 3 weeks.

Inclusion criteria include Standing independently for at least 30 seconds.  Walking independently with or without an assistive device Understand protocol and parents give informed consent. Gross motor functional measure I and II.

Exclusion criteria includeChildren, who are uncooperativeHave history of epilepsy with hearing, visual and speech deficit Any cardiac anomalies affecting exercise tolerance.

 
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