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CTRI Number  CTRI/2023/11/059732 [Registered on: 09/11/2023] Trial Registered Prospectively
Last Modified On: 09/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [occupational therapy]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Effect of sensory integration Vs Sensory integration along with conventional Therapy on participation in daily occupation among stroke survivor- A comparative study 
Scientific Title of Study   A comparative study on effect of sensory integration therapy along with conventional therapy and conventional therapy alone on participation in daily occupation among stroke survivor  
Trial Acronym  NIl 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Charu Sharma 
Designation  MOT student 
Affiliation  Indian Spinal Injuries Centre 
Address  Indian Spinal Injuries Centre Institute Of Rehabilitation Sciences, sector-c Vasant Kunj New Delhi-110070

New Delhi
DELHI
110070
India 
Phone  09650576728  
Fax    
Email  charu9516@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  priyanka vijay 
Designation  assistant professor 
Affiliation  Indian Spinal Injuries Centre 
Address  Indian Spinal Injuries Centre Institute Of Rehabilitation Sciences, Sec-C, Vasant Kunj, New Delhi-110070, 2nd floor Faculty room

New Delhi
DELHI
110070
India 
Phone  9910631430  
Fax    
Email  priyanka_vijay02@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  priyanka vijay 
Designation  assistant professor 
Affiliation  Indian Spinal Injuries Centre 
Address  ISIC Institute Of Rehabilitation Sciences, Sec-C, Vasant Kunj, New Delhi-110070, 2nd Floor Faculty Room

New Delhi
DELHI
110063
India 
Phone  9910631430  
Fax    
Email  priyanka_vijay02@yahoo.co.in  
 
Source of Monetary or Material Support  
Indian Spinal Injuries Centre, Sec-C, Vasant Kunj, New Delhi-110070, Ground Floor Rehabilitation Department 
 
Primary Sponsor  
Name  none 
Address  none  
Type of Sponsor  Other [none] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Priyanka Vijay  Indian Spinal Injuries Centre  2nd floor, Faculty Room, Institute of rehabilitation sciences
New Delhi
DELHI 
9910631430

priyanka_vijay02@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indian Spinal Injuries Center - institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G811||Spastic hemiplegia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional therapy  Clay activity Walking on ramp with handrail Magnetic peg board Buttoning and unbuttoning activity Vertical Sanding unit Catch and throw activity The intervention will be given for a total of 4 weeks, 5 days a week for 40 minutes each day  
Intervention  sensory integration along with conventional therapy  Different textures/materials woven into different art works (craft material, fabrics) min. Clay activity. Crossing obstacles while collecting objects of different weights. Walking on ramp with handrail. Throwing ball in bucket while maintaining balance on therapy ball. Buttoning and unbuttoning activity. The intervention will be given for a total of 4 weeks, 5 days a week for 40 minutes each day  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  3 months after stroke
Age between 18 to 60 years
Both male and female
Modified Barthel Index ≥ 75
Brunnstorm recovery stage of 4
Presence of Sensory processing deficit
Low registration ≤23 and ≥36
Sensory seeking ≤42 and ≥57
Sensory sensitivity ≤25 and ≥42
Sensory avoiding ≤26 and ≥42

 
 
ExclusionCriteria 
Details  Prediagnose orthopedic/neurological condition other than stroke
Uncorrected Vision and Auditory impairments
Any prediagnose psychological condition 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Activity card sort checklist
Stroke specific quality of life.

 
4 weeks 
 
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   Phase 3 
Date of First Enrollment (India)   21/11/2023 
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  
Stroke is the main cause of disability which lead to various body dysfunctions such as motor deficit, difficulty in perceiving and processing sensory input. Sensory processing is the neural process by which information regarding the environment is transmitted to the brain via the peripheral nervous system which allows the individual to select action and give response to the immediate environment. Sensory integration therapy is based on the concept of neuroplasticity, Experience-dependent learning shapes both brain function and behavior. Sensory integration approach enables the individual to learn adaptive response to the physical and social environmental challenges which enhance person ability to integrate, process and modulate sensory information, which further enhances person engagement in occupation and improves their quality of life.
Previous studies have reported that sensory processing and modulation capabilities are significantly affected in stroke survivor. However, no study has addressed the issues related to sensory processing and sensory modulation in stroke. Hence, the aim of
this study is to compare the effect of sensory integration therapy along with the conventional therapy and conventional therapy alone on participation in daily occupation among stroke survivor. In this study ,the participants will be taken from Indian Spinal Injuries center and will be selected on the basis of inclusion criteria, then participants will be divided into two groups (Group A and Group B). Group A will receive sensory integration along with conventional therapy and Group B will receive conventional therapy alone. Pre intervention and post intervention assessment will be done using: Activity card sort checklist and Stroke specific quality of life. The training program will be given for 40 minutes, 5 days a week for 4 weeks.
 
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