| CTRI Number |
CTRI/2025/08/092148 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Supporting Older Adults with Parkinson’s in Physical Therapy: Overcoming Barriers |
|
Scientific Title of Study
|
Participation Challenges in Physical Therapy for Older Adults with Parkinsons 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 |
Amulya Naik |
| Designation |
Post graduate |
| Affiliation |
Sdm college of physiotherapy |
| Address |
OPD NO 13 COMMUNITY PHYSIOTHERAPY DEPARTMENTSDM COLLEGE OF PHYSIOTHERAPY MANJUSHREE NAGAR SATTUR
OPD NO 13 COMMUNITY PHYSIOTHERAPY DEPARTMENT SDM college of physiotherapy MANJUSHREE NAGAR SATTUR DHARWAD
Dharwad
KARNATAKA
580009
India |
| Phone |
8073950542 |
| Fax |
|
| Email |
amulyanaik912@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amulya Naik |
| Designation |
Post graduate |
| Affiliation |
Sdm college of physiotherapy |
| Address |
OPD NO 13 COMMUNITY PHYSIOTHERAPY DEPARTMENT SDM COLLEGE OF PHYSIOTHERAPY MANJUSHREE NAGAR SATTUR
OPD NO 13 COMMUNITY PHYSIOTHERAPY DEPARTMENT Sdm college of physiotherapy MANJUSHREE NAGAR SATTUR DHARWAD
Dharwad
KARNATAKA
580009
India |
| Phone |
8073950542 |
| Fax |
|
| Email |
amulyanaik912@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Salima Bijapuri |
| Designation |
Professor |
| Affiliation |
Sdm college of physiotherapy |
| Address |
OPD NO 13 COMMUNITY PHYSIOTHERAPY DEPARTMENT Sdm college of physiotherapy MANJUSHREE NAGAR satturu Dharwad
OPD NO 13 COMMUNITY PHYSIOTHERAPY department SDM college of physiotherapy MANJUSHREE NAGAR SATTUR DHARWAD
Dharwad
KARNATAKA
580009
India |
| Phone |
917795471277 |
| Fax |
|
| Email |
salima.bijapuri@sdmuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL MANJUSHREE NAGAR SATTUR DHARWAD |
|
|
Primary Sponsor
|
| Name |
Amulya naik |
| Address |
OPD NO 13 COMMUNITY PHYSIOTHERAPY DEPARTMENT SDM COLLEGE OF PHYSIOTHERAPY MANJUSHREE NAGAR SATTUR |
| Type of Sponsor |
Other [Self fund] |
|
|
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 Amulya Naik |
SDM COLLEGE OF PHYSIOTHERAPY |
OPD NO 13 COMMUNITY PHYSIOTHERAPY DEPARTMENT SDM COLLEGE OF PHYSIOTHERAPY MANJUSHREENAGAR SATTUR
Dharwad
KARNATAKA |
8073950542
amulyanaik912@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Older patients(60 years and above) diagnosed
with PD
Patients who have been advised physiotherapy
in the past or are currently undergoing
physiotherapy
Caregivers directly involved in patient care
Participants who provide informed consent |
|
| ExclusionCriteria |
| Details |
Patients with severe cognitive impairment who are unable to respond
Unwilling participants |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The degree to which older adults with Parkinsons disease engage in prescribed physical therapy sessions |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Specific personal, physical, social or environmental factors that limit therapy participation |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
20/08/2025 |
| 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 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
|
Globally, the burden of Parkinson’s disease is rising, and it is projected to increase substantially in developing countries such as India due to demographic transitions and improved life expectancy. Physiotherapy has been recognized as an effective adjunct to pharmacological treatment in managing PD, improving mobility, balance, and quality of life while reducing the risk of falls and physical dependency. Despite strong evidence supporting its benefits, the actual long-term uptake and participation in physiotherapy services remain limited among individuals with PD in India. This limited participation in physiotherapy sessions indicates a significant service delivery gap. Understanding the barriers that prevent individuals with PD from availing themselves of physiotherapy is essential for designing targeted interventions, improving access, and ensuring better health outcomes. These barriers can be physical, psychological, social, and environmental in nature, and they often interact in complex ways.[3] Identifying these factors in the Indian context, where healthcare accessibility varies widely across socioeconomic and geographic strata, is crucial for improving service delivery and patient outcomes. Given the progressive and multifaceted -nature of Parkinson’s disease (PD), identifying the barriers that hinder community engagement is critical for promoting the well-being and social inclusion of affected individuals |