| CTRI Number |
CTRI/2026/01/100170 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational Therapy ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of task oriented training on hand dexterity and strength in children with hemiplegic cerebral palsy in Goa – a quasi-experimental study |
|
Scientific Title of Study
|
Effectiveness Of Task Oriented Training On Hand Dexterity And Strength In Children With Hemiplegic Cerebral Palsy In Goa |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neema Gosavi |
| Designation |
Second Year Master Of Occupational Therapy Student |
| Affiliation |
student |
| Address |
Department of Orthopaedic surgery - occupational therapy , OPD 17 , Goa Medical College, Tiswadi,Bambolim- Goa
OPD 17 , opposite SBI ATM , OPD BLOCK , GOA MEDICAL COLLEGE AND HOSPITAL,Bambolim, Tiswadi Goa , 403202
North Goa
GOA
403202
India |
| Phone |
09373537411 |
| Fax |
|
| Email |
neemgosavi421@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja V Vajaratkar |
| Designation |
Lecturer in Occupational Therapy Student |
| Affiliation |
Goa Medical College |
| Address |
OPD 17 , Department of orthopaedic surgery Goa Medical College
OPD 17 , Department of orthopaedic surgery Goa Medical College
North Goa
GOA
403202
India |
| Phone |
7378412408 |
| Fax |
|
| Email |
pooja.desai5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja V Vajaratkar |
| Designation |
Lecturer Occupational Therapy Student |
| Affiliation |
Goa Medical College |
| Address |
OPD 17 , Department of orthopaedic surgery Goa Medical College
OPD 17 , Department of orthopaedic surgery Goa Medical College
North Goa
GOA
403202
India |
| Phone |
7378412408 |
| Fax |
|
| Email |
p |
|
|
Source of Monetary or Material Support
|
| Goa Medical College and Hospital ,Bambolim- Goa
|
|
|
Primary Sponsor
|
| Name |
Neema Gosavi |
| Address |
department of orthopedic surgery, occupational therapy, Goa medical college,Bambolim Goa 403202 |
| 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 |
| Neema Gosavi |
Goa Medical College |
WARD 149-PNRC
North Goa
GOA |
07066931985
neemgosavi421@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Goa Medical College Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G802||Spastic hemiplegic cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
task oriented training |
Task-Oriented Training (TOT) focuses on improving hand dexterity and strength,Task Oriented Training includes goal-directed activities targeting functional hand use and motor control.
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of Cerebral palsy hemiplegic type with age 5–13 years and levels 1 and 2 on the gross motor function classification system and who is
able to understand Hindi or Konkani or Marathi Or English Language
|
|
| ExclusionCriteria |
| Details |
1) Botulinum toxin A treatment for the upper limb in the previous 6 months and
2) excessive spasticity in the upper limb.
3) poor medical condition
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Improvement in hand dexterity
2.Improvement in hand strength |
Baseline (Day 0, before intervention)
Post-intervention (End of Week 4, after the 12 sessions) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in functional use of the hand in daily activities |
Post-intervention (Week 4) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/01/2026 |
| 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="8"
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
|
This study aims to evaluate the effectiveness of Task-Oriented Training (TOT) on hand dexterity and strength in children with spastic hemiplegic cerebral palsy. A single-group pretest-posttest design will be used, involving 30 participants. The intervention will consist of Task-Oriented Training delivered for 40 minutes per session, 3 times a week, for 4 weeks. The Box and Block Test (BBT) will be used to assess hand dexterity, while hand strength will be measured using a hand dynamometer. Assessments will be conducted at two time points: baseline (Day 0) and post-intervention (Week 4). The study seeks to determine the effectiveness of TOT in improving hand function in this population. |