| 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
|
|
|
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
|
|
|
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. |