| CTRI Number |
CTRI/2021/09/036349 [Registered on: 08/09/2021] Trial Registered Prospectively |
| Last Modified On: |
13/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Sensory Modulation and Occupational Participation in Schizophrenia |
|
Scientific Title of Study
|
Relationship Between Sensory Modulation and Occupational Participation in Individuals with Schizophrenia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shalini Quadros |
| Designation |
Assistant Professor - Senior Scale |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department Of Occupational Therapy, MCHP, MAHE, Manipal
Department Of Occupational Therapy, MCHP, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08197579700 |
| Fax |
|
| Email |
shalini.quadros@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Munoli |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, MAHE |
| Address |
Department Of Psychiatry, KMC, MAHE, Manipal
Department Of Psychiatry, KMC, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09972028881 |
| Fax |
|
| Email |
ravindra.nm@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Shalini Quadros |
| Designation |
Assistant Professor - Senior Scale |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department Of Occupational Therapy, MCHP, MAHE, Manipal
Department Of Occupational Therapy, MCHP, MAHE, Manipal
KARNATAKA
576104
India |
| Phone |
08197579700 |
| Fax |
|
| Email |
shalini.quadros@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions (MCHP), MAHE, Manipal |
|
|
Primary Sponsor
|
| Name |
Shalini Quadros |
| Address |
Department of Occupational Therapy, MAHE, Manipal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Ravindra N Munoli |
Associate Professor, Department of Psychiatry, KMC, Manipal |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ravidra N Munoli |
Kasturba Hospital, Manipal |
Department of Psychiatry,Room number - 33, Manipal
Udupi
KARNATAKA |
0820-2922217
ravindra.nm@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• Adults diagnosed with Schizophrenia as per DSM- V criteria by a psychiatrist
• Clients diagnosed with Schizophrenia with a duration of illness more than 1 year
• Scores more than or equal to 17 in Kannada translated version of Hindi Mental Status Examination (HMSE)
|
|
| ExclusionCriteria |
| Details |
• Clients with any long-term comorbid conditions including cancers, chronic respiratory diseases, diabetes, neuro-generative conditions, any other mental health condition |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Occupational Participation as on Model of Human Occupation Screening Tool (MOHOST) and Sensory Modulation as on Adult Sensory Profile (A/ASP) |
One time at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Positive and Negative Symptoms as on PANSS, Disability scores as on WHODAS 2.0, Cognition as on LOTCA |
One time at baseline |
|
|
Target Sample Size
|
Total Sample Size="138"
Sample Size from India="138"
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)
|
01/01/2022 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A detailed explanation of the study will
be given to the clients diagnosed with schizophrenia and written consent will
be obtained from the client and the caregiver. HMSE will be administered and
clients scoring equal to or more than 17 will only be included in the study.
The severity of symptoms of schizophrenia will be obtained by administering
PANSS followed by which the A/ASP and MOHOST will be administered on the client followed by administration of MOHOST. The UKU-SERS-Clin (to measure the
side effects), WHODAS 2.0 (to measure the disability level), Kuppuswamy`s
socioeconomic status scale will be administered on the participants. The data
obtained will be analyzed for a possible relationship between the A/ASP scores
MOHOST. |