| CTRI Number |
CTRI/2025/10/095632 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparison Between effect of Task- Oriented Training and Proprioceptive Neuromuscular Facilitation Exercise to Improve Upper Extremity Function in Children with Spastic Hemiplegic Cerebral Palsy: An Experimental Study |
|
Scientific Title of Study
|
Comparison Between effect of Task- Oriented Training and Proprioceptive Neuromuscular Facilitation Exercise to Improve Upper Extremity Function in Children with Spastic Hemiplegic Cerebral Palsy: An Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NISHA GOPINATH PAKHARE |
| Designation |
POST GRADUATING |
| Affiliation |
SMT KASHIBAI NAVALE COLLEGE OF PHYSIOTHERAPY |
| Address |
Smt kashibai navale college of physiotherapy,opd 10,NARHE,PUNE-411041
Pune
MAHARASHTRA
411041
India |
| Phone |
9834266328 |
| Fax |
|
| Email |
007ptltmmc1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRRAHUL BISEN |
| Designation |
HOD NEUROPHYSIOTHERAPY DEPARTMENT |
| Affiliation |
SMT KASHIBAI NAVALE COLLEGE OF PHYSIOTHERAPY |
| Address |
Smt kashibai navale college of physiotherapy,opd 10,NARHE,PUNE-411041
Mumbai
MAHARASHTRA
411041
India |
| Phone |
7875606275 |
| Fax |
|
| Email |
007ptltmmc1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DRRAHUL BISEN |
| Designation |
HOD NEUROPHYSIOTHERAPY DEPARTMENT |
| Affiliation |
SMT KASHIBAI NAVALE COLLEGE OF PHYSIOTHERAPY |
| Address |
Smt kashibai navale college of physiotherapy,opd 10,NARHE,PUNE-411041
Mumbai
MAHARASHTRA
411041
India |
| Phone |
7875606275 |
| Fax |
|
| Email |
007ptltmmc1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt kashibai navale college of physiotherapy,opd 10,NARHE,PUNE-411041 |
|
|
Primary Sponsor
|
| Name |
Nisha Gopinath Pakhare |
| Address |
Smt kashibai navale college of physiotherapy,opd 10,NARHE,PUNE-411041 |
| Type of Sponsor |
Other [Charitable hospital] |
|
|
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 |
| Nsiha Gopinath Pakhare |
Smt. Kashibai Navale College Of Physiotherapy |
Smt kashibai navale college of physiotherapy,opd 10,NARHE,PUNE-411041
Pune
MAHARASHTRA |
9834266328
007ptltmmc1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Smt Kashibai Navale College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, , (1) ICD-10 Condition: P111||Other specified brain damage due to birth injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
proprioceptive neuromuscular facilitation training |
d1 and d2 flexion and extension pattern for 4 week |
| Intervention |
task oriented training . |
group A receive task oriented training along with conventional physiotherapy for 4 week
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with spastic hemiplegic Cp
children having co operation and cognitive understanding to participate
spasticity range between 1 and 1+ according to modified ashwarth scale
GMFCS LEVEL I TO III
manual ability classificationsystem level I to III |
|
| ExclusionCriteria |
| Details |
Children who underwent any surgical procedures for upper extremity past 3 months.
Botox injections in past 6 months.
3. Participants with fixed contractures and deformity.
4. Non-corrected visual /auditory impairments. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of upper extremity skill test |
during the start of the intervention protocol ,after 2 weeks of protocol a |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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)
|
15/10/2025 |
| 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="1"
Months="5"
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
|
Approval from institutional ethics committee will be taken. Participants will be selected according to inclusion criteria. Subject information sheet will be given to parents /caretaker and written consent form will be taken . Demographic data will be collected at start of the study. Participants will be divided into GROUP A and GROUP B. Baseline assessment taken with outcome measure and intervention protocol will be given .Data obtained will be statistically analyzed. Discussion will be written depending on the result obtained. |