| CTRI Number |
CTRI/2025/05/087938 [Registered on: 30/05/2025] Trial Registered Prospectively |
| Last Modified On: |
29/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of Home-Based Care on Movement and Quality of Life in People with Early Parkinson’s Disease |
|
Scientific Title of Study
|
Home-Based Care and its effect on Physical Function and Quality of Life in Early Parkinson’s Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shrutika Parab PT |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
MGM School of Physiotherapy MGM Institute of Health Sciences Sector 1 plot no 1 and 2 Kamothe Navi Mumbai Maharashtra
Raigarh
MAHARASHTRA
410209
India |
| Phone |
09969402471 |
| Fax |
|
| Email |
sparab@mgmsopnm.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajani Mullerpatan |
| Designation |
Professor-Director |
| Affiliation |
|
| Address |
MGM School of Physiotherapy MGM Institute of Health Sciences Sector 1 plot no 1 and 2 Kamothe Navi Mumbai Maharashtra
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
rajanikanade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajani Mullerpatan |
| Designation |
Professor-Director |
| Affiliation |
|
| Address |
MGM School of Physiotherapy MGM Institute of Health Sciences Sector 1 plot no 1 and 2 Kamothe Navi Mumbai Maharashtra
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
rajanikanade@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Health Sciences, Sector 1, plot no 1 and 2, Kamothe, Navi Mumbai, Maharashtra, India.
|
|
|
Primary Sponsor
|
| Name |
MGM Institute of Health Sciences, Navi Mumbai |
| Address |
Sector 1, plot no 1 and 2, Kamothe, Navi Mumbai, Maharashtra, India. |
| Type of Sponsor |
Other [Higher Education Institute] |
|
|
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 |
| Dr Shrutika Parab PT |
MGM Hospital |
OPD and IPD, Sector 1 plot no 1 and 2 Kamothe Navi Mumbai Maharashtra
Raigarh
MAHARASHTRA |
09969402471
sparab@mgmsopnm.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on Human subjects of MGM Institute of Health Sciences |
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 |
Control group |
A non-randomized comparative study between individuals with early Parkinson’s disease |
| Intervention |
Home based exercises |
A non-randomized comparative study between individuals with early Parkinson’s disease |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female population, age 45 years and above will be included in the screening part of the study
Both male and female population, age 45 years and above in the early phase Parkinson’s disease who are able to walk for 10 minutes will be included in the study
|
|
| ExclusionCriteria |
| Details |
Individuals who have experienced recent trauma eg-fractures or trauma to the head (within the last three months), those with mild cognitive impairment or delirium, and individuals with autoimmune or other neurological disorders that could impede physical activity, such as stroke, traumatic brain injury, or spinal cord injury. Additionally, participants with cognitive issues that hinder their ability to comprehend instructions (Montreal Cognitive Assessment scores below 10), those with psychological disorders affecting their understanding, individuals with severe dementia, and those already undergoing any form of rehabilitation for Parkinson’s disease will also be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Movement Disorder Society Unified Parkinsons disease Rating Scale MDS-UPDRS
|
Baseline,12 weeks,24 weeks,36 weeks and 52 weeks for follow up
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
IPAQ
WHOQOL-BREF
Mini Nutritional Assessment
|
Baseline,12 weeks,24 weeks,36 weeks and 52 weeks for follow up |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
20/06/2025 |
| 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="3"
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
|
Present study aims to evaluate the effectiveness of a structured Home-Based Rehabilitation program in improving cognitive function, motor function, non-motor symptoms, and quality of life in individuals with early-stage Parkinson’s disease (PD). As part of the study, screening for Parkinson’s disease will be conducted among 33,972 elderly individuals (aged 45 years and above) in Panvel Taluka, Raigad District, Maharashtra, to identify early-stage PD cases. Eligible participants will undergo a standardized Home-Based Rehabilitation protocol, designed to address both motor and non-motor aspects of Parkinson’s disease. The study will assess and compare physical function, cognitive performance, symptom severity, and quality of life before and after the intervention. In addition, the study aims to raise awareness among the population about the benefits of Home-Based Rehabilitation and encourage its adoption for managing early Parkinson’s disease in home settings. |