| CTRI Number |
CTRI/2025/01/079399 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational Therapy] |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of sensory integration therapy and task-oriented training in children with cerebral palsy. |
|
Scientific Title of Study
|
Comparative Effects of Sensory Integration Therapy and Task Oriented Training On Gross Motor Functions in Children with Spastic 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 |
RASHID AKHTAR |
| Designation |
Postgraduate Student(Master in Occupational Therapy) |
| Affiliation |
ISIC Institute of Rehabilitation Sciences |
| Address |
2nd floor institute block,ISIC Institute of Rehabilitation Sciences, Sector C, Vasant Kunj
South West
DELHI
110070
India |
| Phone |
9555515491 |
| Fax |
|
| Email |
rashidak03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lipika Malik |
| Designation |
Assistant Professor, Occupational Therapy Department |
| Affiliation |
ISIC Institute of Rehabilitation Sciences |
| Address |
2nd floor institute block,ISIC Institute of Rehabilitation Sciences, Sector C, Vasant Kunj
South West
DELHI
110070
India |
| Phone |
9999931199 |
| Fax |
|
| Email |
lipika.otist@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lipika Malik |
| Designation |
Assistant Professor, Occupational Therapy Department |
| Affiliation |
ISIC Institute of Rehabilitation Sciences |
| Address |
2nd floor institute block,ISIC Institute of Rehabilitation Sciences, Sector C, Vasant Kunj
South West
DELHI
110070
India |
| Phone |
9999931199 |
| Fax |
|
| Email |
lipika.otist@gmail.com |
|
|
Source of Monetary or Material Support
|
| 2nd floor Institution block, ISIC Institute Of Rehabilitation Sciences, Vasant Kunj New Delhi-110070 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Lipika Malik |
Institute for Child Development |
Occupational Therapy Department C 27 Block C Malviya Nagar New Delhi 110017
New Delhi
DELHI |
9999931199
lipika.otist@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Indian Spinal Injuries Center |
Approved |
|
|
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 |
NA |
NA |
| Intervention |
SENSORY INTEGRATION THERAPY |
Visual processing tasks - Block designs, matching shapes in photographs, puzzles, identifying geometric forms and alphabets, numbers, and categorization.
Body recognition - Indicating various body parts, life-size drawings, rolling right and left sides, and recognizing the body parts by touching.
Tactile awareness - sense different textures, touch boards, and recognize shapes.
Visual-motor coordination training - Ocular-pursuit training, games using pegboards and moving balls
Proprioception - Joint compression, ball squeezing, ball catching and throwing |
| Intervention |
TASK ORIENTED TRAINING |
Kicking ball rolled by therapist while stand by alternate right/left foot.
Sitting on table and reaching an object in different directions.
Stepping forward, backward and sideways on to blocks of various height.
Stand in full base of support and reach the object.
Play around by throwing and rolling a gym ball. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with Spastic Diplegic Cerebral palsy
GMFCS (Gross Motor Function Classification System) Level I to III
Children who can understand and follow command
Modified Asworth scale (Tone) 1 and 1+ |
|
| ExclusionCriteria |
| Details |
Children who undergone any orthopaedic surgery upto 6 months
Taken Botox injection during or before 6 months prior to study
Children diagnosed with IQ below 70
Children diagnosed with uncorrected visual and auditory Impairment
Diagnosed with Intellectual Disability
Children having seizures for the past six months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| GMFM (Gross Motor Function Measure) 88 |
baseline and after 4weeks of intervention |
|
|
Secondary Outcome
|
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
26/01/2026 |
| 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="6"
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
|
Cerebral palsy is a non-progressive disorder affecting motor functions, cognition, learning, speech, and independence. Individuals with cerebral palsy often face muscle tone abnormalities, making it difficult to perform gross motor functions in daily activities. Sensory Integration therapy and task-oriented training are two approaches to improve gross motor skills in children with spastic diplegic cerebral palsy. Comparing sensory integration therapy and task-oriented training can help understand how different intervention strategies affect gross motor function, and which is better among the both intervention. In this study, the participants will be taken from Institute for Child Development of Delhi NCR. Participants will be selected on the basis of inclusion criteria. Study design will be experimental and total sample size is 20. Participants will then be divided into two groups (Group - A and Group -B). i.e 10 participants in each group. Group -A will receive sensory integration therapy and conventional therapy and Group – B will receive task oriented training and conventional therapy. The training programme will be given for 45 minutes, 5 times a week for 4 weeks. |