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CTRI Number  CTRI/2025/06/088570 [Registered on: 10/06/2025] Trial Registered Prospectively
Last Modified On: 10/06/2025
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   Building Strength and Balance: The Role of Exercise for Children with Intellectual Disabilities 
Scientific Title of Study   Impact of Physical and Balance Training on Physical Activity in Children with Intellectual Disability 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Purnima Singh Arya 
Designation  PG Student MPT PAEDIATRICS 
Affiliation  Delhi Pharmaceutical Sciences and Research University 
Address  DELHI PHARMACEUTICAL SCIENCE AND RESEARCH UNIVERSITY SECTOR 3 PUSHP VIHAR M B ROAD NEW DELHI

South
DELHI
110017
India 
Phone  9319501174  
Fax    
Email  purnima37.bpt2018@dpsru.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  DR SAPNA DHIMAN PT 
Designation  ASSISTANT PROFESSOR 
Affiliation  DELHI PHARMACEUTICAL SCIENCE AND RESEARCH UNIVERSITY 
Address  ROOM NUMBER 602 6TH FLOOR DPSRU SECTOR 3 PUSHP VIHAR M ROAD NEW DELHI

South
DELHI
110017
India 
Phone  8588055147  
Fax    
Email  sapnaphysio@dpsru.edu.in  
 
Details of Contact Person
Public Query
 
Name  PURNIMA SINGH ARYA 
Designation  PG STUDENT MPT PAEDIATRICS 
Affiliation  DELHI PHARMACEUTICAL SCIENCE AND RESEARCH UNIVERSITY 
Address  DELHI PHARMACEUTICAL SCIENCE AND RESEARCH UNIVERSITY SECTOR 3 PUSHP VIHAR M B ROAD NEW DELHI

South
DELHI
110017
India 
Phone  9319501174  
Fax    
Email  purnima37.bpt2018@dpsru.edu.in  
 
Source of Monetary or Material Support  
DELHI PHARMACEUTICAL SCIENCE AND RESEARCH UNIVERSITY SECTOR 3 PUSHP VIHAR M B ROAD NEW DELHI 110017 
 
Primary Sponsor  
Name  DELHI PHARMACEUTICAL SCIENCE AND RESEARCH UNIVERSITY  
Address  ROOM NUMBER 602 6TH FLOOR DELHI PHARMACEUTICAL SCIENCE AND RESEARCH UNIVERSITY SECTOR 3 PUSHP VIHAR M B ROAD NEW DELHI 110017 
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 
PURNIMA SINGH ARYA  PAEDIATRICS OPD DELHI PHARMACEUTICALS SCIENCE AND RESEARCH UNVIERSITY SECTOR 3 M B ROAD NEW DELHI  PAEDIARTCIS OPD DPSRU SECTOR 3 PUSHP VIHAR M B ROAD NEW DELHI 110017
South
DELHI 
9319501174

purnima37.bpt2018@dpsru.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F70||Mild intellectual disabilities,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  PHYSICAL EXERCISES  THIS GROUP RECIEVE SCHOOL PHYSICAL ACTIVITIES OCCUR DURING GAMES PERIOD OR OTHER ACTIVITIES 
Intervention  PHYSICAL FITNESS AND BALANCE EXERCISES  3 SESSION PER WEEK FOR 6 WEEKS THIS GROUP RECIEVE PHYSICAL AND BALANCE EXERCISES. IN PHYSICAL EXERCISES STRENGTH AND ENDURANCE EXERCISES WILL BE GIVEN WHILE FOR BALANCE DIFFERENT BALANCE EXERCISES WILL BE GIVEN. 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. CHILDREN WITH MILD TO MODERATE INTELLECTUAL DISABILITY
2. GOING TO SCHOOL REGULARLY
3. ABLE TO WALK INDEPENDENTLY
4. ABLE TO COMMUNICATE
5. IQ MORE THAN 34 AND LESS THAN 69 
 
ExclusionCriteria 
Details  Children with recent injury and orthopaedic conditions/ neurological conditions/
metabolic conditions/ cardiopulmonary conditions
Hearing and visual impairments
Child taking any psychiatric treatment
Genetics condition
Using any assistive device  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. STRENGTH
2. ENDURANCE
3. BALANCE
4. PHYSICAL ACTIVITY LEVEL 
AT THE STARTING PF THE SESSION AND END OF 6TH WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
BMI  AT THE STARTING OF THE SESSION AND END OF 6TH WEEKS 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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)   24/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  24/06/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
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  

The study title is " Impact of Physical and Balance Training on Physical Activity in Children with Intellectual Disability." It will examine the effect of Physical and Balance exercises on children having  Intellectual Disability (ID) having mild to moderate ID. Deficits in general mental abilities such as reasoning, problem solving, planning, abstract thinking, judgment, academic learning, and experiential learning characterize ID. According to reports, the prevalence of ID is 1% worldwide, varying by nation from 1% to 3%. The male-to-female ratio is 2:1. While the percentage of people with mild ID has decreased recently, the percentage of people with severe ID has stayed constant at between 0.3% and 0.5% of the population. It relies on three categories: educable mental retardation (based on an IQ of 50 to about 70–75), trainable mental retardation (IQ 30 to 50), and severe mental retardation (IQ below 30). This study aims to find the effect of physical and balance exercise on strength, endurance, balance, and physical activity in children having ID. The study is an Experimental study, involving 38 participants (19 in each group), aged 10-12 years, who have mild to moderate ID. The participants will be randomly assigned to either of experimental group or the control group. The experimental group will receive a 45-minute session of exercise, including a warm-up phase, main exercise phase, and the cool-down phase in which includes different physical and balance exercises, while the control group will have educational and school physical activities. The primary assessment includes the stair climbing test, sit-to-stand test, time up and go test, single leg standing test, and physical activity questionnaire for children and adolescents (PAQ-C) conducted at 0 and 6th week. The Shapiro-Wilk test will be used to check the normal distribution of data. Depending on the normality of the data parametric or non-parametric test will be administered. Parametric test includes paired and unpaired t test for within and between-group analysis, and non-parametric tests include the Mann-Whitney U test. Ultimately, the findings aim to contribute valuable insights into rehabilitation practices for ID children to improve their Physical abilities to perform activities of daily living.

 
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