| 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
|
|
|
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
|
|
|
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. |