| CTRI Number |
CTRI/2025/05/086742 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
09/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Multi-Modal Exercises in Improving Cognitive & Sensory-Motor Function among Children with Attention Deficit Hyperactivity Disorder |
|
Scientific Title of Study
|
Effect of Multi-Modal Exercise Program on Cognitive & Sensory-Motor Function among Children with Attention Deficit Hyperactivity Disorder: A 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 |
Nidhi Sharma |
| Designation |
Ph.D. Scholar |
| Affiliation |
Galgotias University |
| Address |
Block B, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University
Plot No. 2, Sector 17-A
Gautam Buddha Nagar
Yamuna Expressway
Greater Noida-203201
Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7508672524 |
| Fax |
|
| Email |
sharmanidhi1411@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aksh Chahal |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Block B, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University
Plot No. 2, Sector 17-A
Gautam Buddha Nagar
Yamuna Expressway
Greater Noida-203201
Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9711774174 |
| Fax |
|
| Email |
drakshchahal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aksh Chahal |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Block B, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University
Plot No. 2, Sector 17-A
Gautam Buddha Nagar
Yamuna Expressway
Greater Noida-203201
Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9711774174 |
| Fax |
|
| Email |
drakshchahal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nidhi Sharma |
| Address |
Galgotias University
Plot No. 2, Sector 17-A
Gautam Buddha Nagar
Yamuna Expressway
Greater Noida-203201
Uttar Pradesh |
| 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 |
| Dr Nidhi Sharma |
Uttaranchal Hospital & Diagnostic Centre |
Ground Floor, Physiotherapy Department, Uttaranchal Hospital & Diagnostic Centre, Premnagar, Dehradun
Dehradun
UTTARANCHAL |
7508672524
sharmanidhi1411@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School Ethics Committee, Galgotias University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F902||Attention-deficit hyperactivity disorder, combined type, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sensory-Motor and Attention Refinement Training for children with Attention Deficit Hyperactivity Disorder |
8 weeks |
| Comparator Agent |
Standard routine care therapy |
8 weeks |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children with a clinical diagnosis of ADHD;
Cooperation in understanding to perform task determined via Modified Mini Mental Scale for Cognitive Function in Children;
Child and parent consent to participate
|
|
| ExclusionCriteria |
| Details |
Children who underwent recent surgical procedure
Visual and auditory impairment
Children with associated birth defects and congenital anomalies
Children with a diagnosed neurological disorder and systemic diseases other than ADHD
Physical deficits leading to motor disorders |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pediatric Balance Scale;
Short Sensory Profile;
Trail Making Test;
DCDQ’07 (Developmental Coordination Disorder Questionnaire 2007)
|
baseline, 2 week, 4 week, 8 weeks.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
20/05/2025 |
| 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="0"
Months="10"
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 is a 2-group pretest post-test randomized controlled trial to evaluate the efficacy of Sensory-Motor and Attention Refinement Training for children with Attention Deficit Hyperactivity Disorder aimed at improving sensory, motor, and cognitive function. Participants meeting the inclusion criteria will be recruited. Following baseline assessments, children will be allocated to either the Experimental or Control Group. Follow-up assessment will be repeated after 2 weeks, 4 weeks, at the end of the training program. |