| CTRI Number |
CTRI/2026/01/102149 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess memory, thinking ability, movement, and balance in patients with Parkinson disease. |
|
Scientific Title of Study
|
Cognitive and Motor Function Assessment in Parkinson Disease Patients. |
| 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 Praveen Kumar Maywad |
| Designation |
Junior Resident |
| Affiliation |
Gandhi Medical College, Bhopal |
| Address |
54 Piyush Nagar Awadhpuri Bhopal
Bhopal
MADHYA PRADESH
462022
India |
| Phone |
9131460017 |
| Fax |
|
| Email |
praveenmaywad2810@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subodh Pandey |
| Designation |
Professor and Head |
| Affiliation |
Gandhi Medical College, Bhopal |
| Address |
Department of physiology, Gandhi Medical College, Sultania Road, Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8319179596 |
| Fax |
8319179596 |
| Email |
subodhpandey97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Kumar Maywad |
| Designation |
Junior Resident |
| Affiliation |
Gandhi Medical College, Bhopal |
| Address |
54 Piyush Nagar Awadhpuri Bhopal
MADHYA PRADESH
462022
India |
| Phone |
9131460017 |
| Fax |
|
| Email |
praveenmaywad2810@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr PRAVEEN K MAYWAD |
| Address |
54, Piyush Nagar
Awadhpuri |
| Type of Sponsor |
Government medical college |
|
|
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 Praveen K Maywad |
Gandhi Medical College, Bhopal |
Main building, 2nd floor, Department of physiology, Neurophysiology Laboratory
Bhopal
MADHYA PRADESH |
9131460017
praveenmaywad2810@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
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 |
80.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed Parkinson disease patients
Hoehn Yahr stage I–III
Male and female patients
Able to walk and perform motor tasks safely
Mentally capable of understanding instructions
Willing to participate and provide written informed consent |
|
| ExclusionCriteria |
| Details |
Atypical parkinsonism
Advanced Parkinson disease (Hoehn Yahr stage IV–V)
Severe orthopedic, neurological, or medical illness affecting test performance |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cognitive function assessed by Montreal Cognitive Assessment (MoCA) score |
Single assessment at enrollment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Upper limb motor function:
Finger Tapping Test (number of taps in 10 seconds)
Nine-Hole Peg Test (completion time in seconds)
Spiral Drawing Test (tremor severity score)
Lower limb strength and mobility:
Five Times Sit-to-Stand Test (seconds)
30-Second Chair Stand Test (number of repetitions)
Gait and balance:
Timed Up and Go Test (seconds)
10-Metre Walk Test (gait speed in m/s)
Tandem Gait Test (qualitative assessment)
Wii Fit Balance Board Test (center of pressure parameters) |
Single assessment session |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
05/02/2026 |
| 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="6"
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
|
This is an observational, single-center study conducted as part of an MD Physiology thesis at Gandhi Medical College, Bhopal. The study aims to assess cognitive function and multiple motor domains in patients with mild to moderate Parkinson’s disease (Hoehn & Yahr stage I–III). Participants will undergo a comprehensive assessment including cognitive screening using the Montreal Cognitive Assessment (MoCA), upper and lower limb motor tests, gait analysis, and balance evaluation. The study seeks to characterize the pattern of cognitive and motor impairment in an Indian Parkinson’s disease cohort and provide data relevant for early identification of functional decline and rehabilitation planning. |