| CTRI Number |
CTRI/2025/07/090436 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Development of scale and determination of its psychometric properties |
| Study Design |
Other |
|
Public Title of Study
|
Development of Parkinson’s Disease Motor Assessment Scale and establishing its psychometric properties |
|
Scientific Title of Study
|
Development of Parkinson’s Disease Motor Assessment Scale and establishing its psychometric properties |
| 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 Snehal Joshi PT |
| Designation |
Principal and HOD Neurophysiotherapy department |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy |
| Address |
Neurophysiotherapy Department, DES Brijlal Jindal College of Physiotherapy, Fergusson College Campus, Shivajinagar,Pune-411004.
Pune
MAHARASHTRA
411004
India |
| Phone |
9225340940 |
| Fax |
|
| Email |
snehal.joshi@despune.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishnavi Dubey PT |
| Designation |
Postgraduate Student |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy |
| Address |
Neurophysiotherapy Department, DES Brijlal Jindal College of Physiotherapy, Fergusson College Campus, Shivajinagar,Pune 411004.
Pune
MAHARASHTRA
411004
India |
| Phone |
9423545496 |
| Fax |
|
| Email |
vaishnavi.dubey496@deccansociety.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishnavi Dubey PT |
| Designation |
Postgraduate Student |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy |
| Address |
Neurophysiotherapy Department, DES Brijlal Jindal College of Physiotherapy, Fergusson College Campus, Shivajinagar,Pune 411004.
Pune
MAHARASHTRA
411004
India |
| Phone |
9423545496 |
| Fax |
|
| Email |
vaishnavi.dubey496@deccansociety.org |
|
|
Source of Monetary or Material Support
|
| DES Brijlal Jindal College of Physiotherapy, Fergusson College Campus, Shivajinagar, Pune, Maharashtra, India- 411004. |
|
|
Primary Sponsor
|
| Name |
Dr Vaishnavi Dubey |
| Address |
Neurophysiotherapy Department, DES Brijlal Jindal College of Physiotherapy, Fergusson College Campus, Shivajinagar,Pune 411004. |
| 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 |
| Dr Vaishnavi Dubey PT |
Neuro rehab centres and Community settings, Pune |
Neuro physiotherapy department, Ground floor, DES Brijlal Jindal College of Physiotherapy, Fergusson College Campus, Shivajinagar, Pune, Maharashtra, India 411004.
Pune
MAHARASHTRA |
9423545496
vaishnavi.dubey496@deccansociety.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC DESBJCOP |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria
All individuals diagnosed with Parkinsons disease
Willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria
Individuals with evidence of other neurological disorders
Not able to follow commands
Any condition that affects the quality of movement other than Parkinsons disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development of Parkinson’s Disease Motor Assessment Scale |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Establishing content validity & concurrent validity, inter-rater & intrarater reliability |
8 months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
31/07/2025 |
| 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
|
Parkinson’s Disease Motor Assessment Scale is a clinical tool designed to evaluate motor components of Parkinson’s Disease. The scale consists of six main domains: Rigidity, Bradykinesia, Tremors, Postural instability, Posture, and Gait. The aim of designing this scale is to develop a streamlined version that focuses on essential motor parameters. The primary objective of developing this new Parkinson’s disease motor assessment scale is to create a more streamlined and practical version of existing rating scales, ensuring that it is both comprehensive and efficient in evaluating motor impairments. This new scale aims to refine the assessment process by focusing specifically on motor symptoms and functional impairments that are most crucial for physiotherapists when designing and implementing treatment plans. A key feature of this scale is that it will be therapist-rated rather than relying on patient self-reporting, which can sometimes introduce variability due to differences in perception, cognitive function, and communication abilities. The study will be conducted in multiple phases: Item generation through literature review and expert consultation. Face validity and revision of scale. Psychometric validation including content validity, internal consistency, and inter-rater reliabiity. |