| CTRI Number |
CTRI/2024/06/069517 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
This Research Study is conducted among people affected with PARKINSON’S DISEASE and it attempts to find out what Symptoms or Issues they find to trouble them by conducting a Simple Survey |
|
Scientific Title of Study
|
Parkinsons Disease Patients Coping Preferences Of Their Most Bothersome Symptoms. A Survey |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Erol Vaz |
| Designation |
Postgraduate Student |
| Affiliation |
Father Muller College of Physiotherapy |
| Address |
Department of Neuro Physiotherapy
Father Muller College of Physiotherapy Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8888886545 |
| Fax |
|
| Email |
erolvaz15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sydney Roshan Rebello |
| Designation |
Professor |
| Affiliation |
Father Muller College of Physiotherapy |
| Address |
Department of Neuro Physiotherapy
Father Muller College of Physiotherapy
Kankanady Mangalore
Kankanady Mangalore Karnataka 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9343569219 |
| Fax |
|
| Email |
sydnypt@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Erol Vaz |
| Designation |
Postgraduate Student |
| Affiliation |
Father Muller College of Physiotherapy |
| Address |
Department of Neuro Physiotherapy
Father Muller College of Physiotherapy
Kankanady Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8888886545 |
| Fax |
|
| Email |
erolvaz15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical College & Hospital Kankanady Mangalore Karntaka 575002 India |
|
|
Primary Sponsor
|
| Name |
Erol Vaz |
| Address |
St Agustine Complex T-4 Opposite HDFC Bank Santa Cruz Goa 403005 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Erol Vaz |
Father Muller Medical College & Hospital |
Department of Neuro Physiotherapy
Dakshina Kannada
KARNATAKA |
8888886545
erolvaz15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Parkinson’s Disease diagnosed by neurologists.
Age group between 40 to 80 years.
|
|
| ExclusionCriteria |
| Details |
Patients with other neurodegenerative disorders that present with history of cerebral vascular accident or transient ischemic attack, history of epilepsy or cerebral tumor, history of head injury with loss of consciousness, history of being on treatment with neuroleptic drugs, presence of any physical illness associated with chronic confusional state.
History of psychiatric illness.
Patients who do not consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Most bothersome symptom - Questionnaire |
Once during the survey |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Coping Preference - Questionnaire |
Once during the survey |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
05/07/2024 |
| 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="0"
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
|
The need of this study is to determine which of
the various PD symptoms are most bothersome for patients, as well as what kind
of support, these individuals they may need. RESEARCH QUESTIONS: What are the most bothersome symptoms and coping
preferences of Parkinson’s Disease patients. INCLUSION
CRITERIA:
• Patients
with Parkinson’s Disease diagnosed by neurologists
• Age
group between 40 to 80 years
EXCLUSION
CRITERIA:
·
Patients with other neurodegenerative disorders that
present with history of cerebral vascular accident or transient ischemic
attack, history of epilepsy or cerebral tumor, history of head injury with loss
of consciousness, history of being on treatment with neuroleptic drugs,
presence of any physical illness associated with chronic confusional state
·
History
of psychiatric illness.
·
Patients
who do not consent Procedure: After consenting to the study, Demographic
details will be obtained from every subject via an interview-based method and
recorded on a data collection proforma. PD Patients will then undergo a
screening to classify the severity of the condition via the MDS Unified
Parkinson’s Disease Rating Scale (UPDRS). Participants will be scored on PDQ-
39 to assess Quality Of Life. The Survey Questionnaire with open ended
questions will then be administered. The data collected will be analyzed with
SPSS software. |