| CTRI Number |
CTRI/2018/07/014918 [Registered on: 17/07/2018] Trial Registered Prospectively |
| Last Modified On: |
03/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Sensory Integration therapy] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomized control trial on effectiveness of sensory integration therapy on motor activity among mentally challenged children |
|
Scientific Title of Study
|
A study to assess the effectiveness of sensory integration therapy on motor activity among mentally challenged children at selected special school in Kozhikode District |
| Trial Acronym |
ESITMAMCC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nimya M |
| Designation |
Post Graduate Student |
| Affiliation |
MIMS College of Nursing |
| Address |
MIMS College of Nursing
Vadakedathparamba
Puthukode PO
Vazhayur
Near Ramanattukara
Malappuram District
Malappuram
KERALA
673633
India |
| Phone |
8281252590 |
| Fax |
04832832992 |
| Email |
nimyamhn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Assuma Beevi T M |
| Designation |
Principal |
| Affiliation |
MIMS College of Nursing |
| Address |
MIMS College of Nursing
Vadakedathparamba
Puthukode PO
Vazhayur
Near Ramanattukara
Malappuram District
Malappuram
KERALA
673633
India |
| Phone |
9895780859 |
| Fax |
04832832992 |
| Email |
principal@mimscon.com |
|
Details of Contact Person
Public Query
|
| Name |
Nimya M |
| Designation |
Post Graduate Student |
| Affiliation |
MIMS College of Nursing |
| Address |
MIMS College of Nursing
Vadakedathparamba
Puthukode PO
Vazhayur
Near Ramanattukara
Malappuram District
Malappuram
KERALA
673633
India |
| Phone |
8281252590 |
| Fax |
04832832992 |
| Email |
nimyamhn@gmail.com |
|
|
Source of Monetary or Material Support
|
| MIMS College of Nursing
Vadakedathparamba
Puthukode P O
Vazhayur
Near Ramanattukara
Malappuram District
Pin-673633 |
|
|
Primary Sponsor
|
| Name |
MIMS College of Nursing |
| Address |
Vadakedathparamba
Puthukode P.O.
Vazhayur
Near Ramanattukara
Malappuram District
|
| Type of Sponsor |
Research institution |
|
|
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 |
| Nimya M |
Asha Kiran School for differentially abled |
Devagiri Road, Medical College Post, Devgiri, Kozhikode, Kerala 673008
Kozhikode
KERALA |
8281252590
04832832992
nimyamhn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Malabar Institute of Medical Sciences Ltd (MIMS) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Mentally Challenged Children, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Sensory Integration therapy |
A form of therapy in which the therapist may
encourage a child with jumping, walking heel raised, zig zag hopping, playing catch and bouncing
balls with both hands to help with bilateral integration
Frequency: 1 hour daily
Total duration of Therapy: 21 days |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Mild to moderate mentally challenged children with motor impairment |
|
| ExclusionCriteria |
| Details |
Children with medical illness
Visually and auditory impaired children |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Motor Activity |
From first patient to 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/12/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="12" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized controlled
trial to evaluate the effectiveness of sensory integration therapy on motor
activity among mentally challenged children. The purpose of the study is to
makes the child capable of doing daily activities independently.60 sample for
the study will be selected by lottery method of simple random sampling (30 for
experimental and, 30 for control). Basic information will be collected using
Socio demographic proforma and clinical data sheet. Pre test will be conducted
by using structured observation checklist for motor activity assessment.
Following pretest, sensory integration therapy will be given to sample that are
included in experimental group. The subject in the experimental group will be
divided in to 6 groups, each group with five children. Sensory integration
therapy will be provided one hour a day for 20 consecutive days. Post test will
be done immediately after the intervention by using same scale. After the
actual study, the control group will also be provided with sensory integration
therapy.The data analysis will be done using descriptive and inferential
statistics. |