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CTRI Number  CTRI/2025/05/087978 [Registered on: 30/05/2025] Trial Registered Prospectively
Last Modified On: 29/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Qualitative 
Study Design  Other 
Public Title of Study   Caregivers view of what helps and hinders Home Exercise Programme (HEP) in people with Parkinson’s – A Qualitative Study 
Scientific Title of Study   Caregivers perception of Enablers and Barriers to Home Exercise Programme (HEP) in Parkinson Patients- A Qualitative study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Fathima M  
Designation  MPT 
Affiliation  Father Muller College Of Physiotherapy 
Address  Jannah (po) Peringadi, New Mahe, Thalassery, Kannur, India

Kannur
KERALA
673312
India 
Phone  7034310584  
Fax    
Email  fathimafaathi7@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sydney Roshan Rebello 
Designation  Professor 
Affiliation  Father Muller College Of Physiotherapy 
Address  Father Muller Medical Hospital, Department of Neurophysiotherapy, Father Muller Road, Kankanady Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9343569219  
Fax    
Email  sydnypt@fathermuller.in  
 
Details of Contact Person
Public Query
 
Name  Sydney Roshan Rebello 
Designation  Professor 
Affiliation  Father Muller College Of Physiotherapy 
Address  Father Muller Medical Hospital, Department of Neurophysiotherapy, Father Muller Road, Kankanady Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9343569219  
Fax    
Email  sydnypt@fathermuller.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Fathima M 
Address  Jannah (po) Peringadi, New Mahe, Thalassery, Kannur, Kerala, India, 673312 
Type of Sponsor  Other [self] 
 
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 
Fathima M  Father Muller Medical College  Department of neurophysiotherapy, R ward, 3rd floor, father Muller Medical College ,father Muller Road, Kankanady, Mangalore
Dakshina Kannada
KARNATAKA 
7034310584

fathimafaathi7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committee (FMIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Parkinsons patients caregiver 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Caregivers of Parkinson patients.
Caregivers of patients with Barthel Index activities of daily living score between 0-80%
Caregiver who are willing to give an informed consent.  
 
ExclusionCriteria 
Details  • Paid caregivers or professional healthcare workers.
• Multiple caregivers for the same patient.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
SEMI-STRUCTURED QUESTIONNAIRE  30 to 45 min 
 
Secondary Outcome  
Outcome  TimePoints 
THE BARTHEL INDEX total score 0 to 100  5min 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   16/06/2025 
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 Yet Recruiting 
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  

A progressive neurodegenerative condition, Parkinsons disease PD results in both motor and non motor abnormalities. It is linked to the destruction of dopaminergic neurons and a subsequent drop in the neurotransmitter dopamine. The average prevalence of Parkinsons disease PD worldwide is 160 per 100000 suggesting that the condition may be more prevalent in India. .

 It is anticipated that the number of PD patients will also rise as the population ages in the future. Parkinsons disease affects about 1 to 2 people out of every 1000 in the general population but the number of cases increases with age. Around 1% of people over the age of 60 are affected, and both new and existing cases become more common as people get older. People with Parkinson disease benefit from exercise because it reduces impairment and enhances quality of life.

 

Since home rehabilitation helps patients improve their motor function and form self-exercising habits it is a promising substitute for outpatient or inpatient rehabilitation programs. Prior research has demonstrated that exercising at home significantly enhances quality of life, stepping qualities, and balance. 

Family members frequently serve as caregivers helping with everyday tasks and offering emotional support during the healing process.

 

They rely on caregivers to help them with everyday living activities as well as to continue their rehabilitation through at home exercise regimens. .

 In the community maintaining a consistent exercise regimen is a common challenge for both healthy and chronically disabled older adults. 

 

Researchers have explored various elements that may impact the consistency of exercise participation in older adults and have introduced the term motivator  to explain aspects that encourage participation and the term barriers which explain those hinder participation. The Need of the study is to find out the enablers and barriers of PD patients in HEP through caregivers perception.

 
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