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
|
|
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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Parkinsons patients caregiver |
|
Intervention / Comparator Agent
|
|
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. |