| CTRI Number |
CTRI/2025/08/092599 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Improving function and participation in children with cerebral palsy using neurodevelopmental treatment. |
|
Scientific Title of Study
|
Effect of Neurodevelopmental treatment in improving function and participation of children with Diplegic Cerebral Palsy |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandeep Khanna |
| Designation |
Research Scholar |
| Affiliation |
Sardar Bhagwan Singh University |
| Address |
Department of Physiotherapy, Sardar Bhagwan Singh University, Balawala, Dehradun
Dehradun
UTTARANCHAL
248161
India |
| Phone |
9897473362 |
| Fax |
|
| Email |
sandeep.khanna22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr R Arunmozhi |
| Designation |
Professor |
| Affiliation |
Sardar Bhagwan Singh University |
| Address |
Department of Physiotherapy, Sardar Bhagwan Singh University, Balawala, Dehradun
Dehradun
UTTARANCHAL
248161
India |
| Phone |
7895617031 |
| Fax |
|
| Email |
rmozhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr R Arunmozhi |
| Designation |
Professor |
| Affiliation |
Sardar Bhagwan Singh University |
| Address |
Department of Physiotherapy, Sardar Bhagwan Singh University, Balawala, Dehradun
Dehradun
UTTARANCHAL
248161
India |
| Phone |
7895617031 |
| Fax |
|
| Email |
rmozhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Latika,
Latika Roy Memorial Foundation,
113/1, Vasant Vihar, Dehradun, Pin code 248001, Uttarakhand, India. |
|
|
Primary Sponsor
|
| Name |
Sandeep Khanna |
| Address |
Latika,
Latika Roy Memorial Foundation, 113/1, Vasant Vihar, Dehradun, Pin Code- 248001, Uttarakhand, India |
| Type of Sponsor |
Other [Non-Government Organisation] |
|
|
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 |
| Sandeep Khanna |
Latika Roy Memorial Foundation |
Department of Physiotherapy, Latika Roy Memorial Foundation
113/1, Vasant Vihar
Dehradun
Dehradun
UTTARANCHAL |
9897473362
sandeep.khanna22@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Review Board of Sardar Bhagwan Singh University |
Approved |
| Institutional Review Board of Sardar Bhagwan Singh University |
Approved |
| Latika NOC |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G801||Spastic diplegic cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Home management Program |
Parents will be provided hands-on training on how to continue at therapy at home to their children in a home management program. Parents in this group will receive 2 or 3 face to face interactions within 10 weeks of study period with a trained therapist to check how home management program is being carried and to clarify any doubts or additional suggestions. |
| Intervention |
Neurodevelopmental Treatment |
Participants will undergo neurodevelopmental treatment intervention including handling and facilitation during the activities of the day 45 minutes session per day, 4 days a week for 10 weeks. Specific activation and strengthening will be done by the therapist and carry over will be explained to the parents who will continue the home based management program. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Diplegic Cerebral Palsy children aged between 5 to 12 years from Dehradun district with Gross motor classification system, manual ability classification system and communication function classification system as I-III. |
|
| ExclusionCriteria |
| Details |
Other neurodevelopmental disorders like Down syndrome, metabolic disorders and genetic conditions. Medical conditions or recurrent illness including seizures, respiratory disorder or dysphagia. Any history of orthopedic/ neurological surgical procedures within 6 months before enrollment in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
- Canadian Occupational Performance Measure scale
- Child Engagement in daily life measure (Version 2)
- Gross Motor Function Measure-66
- Functional Independence Measure (Weefim)
|
At the start of the study at the start of the study (1.8.2025 to 8 October 2025)
End of the study post 10 weeks of intervention methods. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Goal Attainment Scale
Pediatric Balance Scale |
At the start of the study (1.8.2025 to 8 October 2025)
End of the study post 10 weeks of intervention methods. |
|
Target Sample Size
Modification(s)
|
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
|
N/A |
|
Date of First Enrollment (India)
|
18/08/2025 |
| 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="2"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
Modification(s)
|
Potential participants will be screened for eligibility criteria and after obtaining well-informed written consent of the parent(s) or legal guardian of the child, the child will be recruited as a participant. The participants will be distributed into experimental group/ group A (NDT and Home management program) and control group/ group B (Home management program only). Pre-intervention data will be collected using predetermined primary and secondary outcome measures. The planned intervention would be carried out for 10 weeks. NDT will be applied by trained therapists and parents will be trained to continue the home management program.
Experimental Group (Group A): Participants will undergo NDT intervention including handling and facilitation during the activities of the day, 4 days a week for 10 weeks. Specific activation and strengthening will be done by the therapist and carry-over will be explained to parents who will continue the home management program.
Control Group (Group B): Parents will be provided hands-on training on how to continue therapy at home for their children in a home management program. Parents and this group will receive 2/3 face-to-face interactions within 10 weeks of the study period with a trained therapist to check how the home management program is being carried out and to clarify any doubts or make additional suggestions. Post-intervention data will be collected for both groups using the below-listed primary and secondary outcome measures.
Outcome measures: Primary Outcome measure: - COPM scale - Child Engagement in daily life measure (Version 2) - GMFM-66 - WeeFim
Secondary Outcome Measure: - Goal Attainment Scale - Pediatric balance scale
|