| CTRI Number |
CTRI/2025/08/092564 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Looking at What Influences Gait in Parkinson’s Disease |
|
Scientific Title of Study
|
Comparative analysis of factors influencing gait in patients with Parkinson 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 |
Harshitha s |
| Designation |
Post graduate student |
| Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY |
| Address |
OPD NO 5 Neurophysiotherapy Department Shri Dharmasthala Manjunatheshwara College of Medical sciences and hospital Manjushree Nagar Sattur Dharwad 580009
OPD NO 5 Neurophysiotherapy Department Shri Dharmasthala Manjunatheshwara College of Medical sciences and hospital Manjushree Nagar Sattur Dharwad 580009
Dharwad
KARNATAKA
58009
India |
| Phone |
9380037753 |
| Fax |
|
| Email |
harshithashanmugam484848@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Harshitha s |
| Designation |
Post graduate student |
| Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY |
| Address |
OPD NO 5 Neurophysiotherapy Department Shri Dharmasthala Manjunatheshwara College of Medical sciences and hospital Manjushree Nagar Sattur Dharwad 580009
OPD NO 5 Neurophysiotherapy Department Shri Dharmasthala Manjunatheshwara College of Medical sciences and hospital Manjushree Nagar Sattur Dharwad 580009
Dharwad
KARNATAKA
58009
India |
| Phone |
9380037753 |
| Fax |
|
| Email |
harshithashanmugam484848@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudhir Bhatbolan |
| Designation |
Professor and PG guide |
| Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY |
| Address |
OPD NO 5 Neurophysiotherapy Department Shri Dharmasthala Manjunatheshwara College of Medical sciences and hospital Manjushree Nagar Sattur Dharwad 580009
OPD NO 5 Neurophysiotherapy Department Shri Dharmasthala Manjunatheshwara College of Medical sciences and hospital Manjushree Nagar Sattur Dharwad 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9886475757 |
| Fax |
|
| Email |
sudhirbhatbolan@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM college of medical science and hospital, SDM college of physiotherapy , Manjushree Nagar, Sattur, Dharwad 580009 India |
|
|
Primary Sponsor
|
| Name |
Harshitha s |
| Address |
OPD NO 5 Neurophysiotherapy Department Shri Dharmasthala Manjunatheshwara College of Medical sciences and hospital Manjushree Nagar Sattur Dharwad 580009 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harshitha S |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
OPD NO 5 Neurophysiotherapy Department Shri Dharmasthala Manjunatheshwara College of Medical sciences and hospital Manjushree Nagar Sattur Dharwad 580009
Dharwad
KARNATAKA |
9380037753
harshithashanmugam484848@gmail.com |
| Dr Sudhir Bhatbolan |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
OPD NO 5 Neurophysiotherapy Department Shri Dharmasthala Manjunatheshwara College of Medical sciences and hospital Manjushree Nagar Sattur Dharwad 580009
Dharwad
KARNATAKA |
09886475757
sudhirbhatbolan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
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 |
Group A |
Gait analysis |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with idiopathic PD by qualified medical practitioner
2. Any gender
3. Patients who are able to walk independently without assistance, (with or without supervision).
4. Patients willing to participate and give informed consent
5. Patients who have normal or corrected vision and hearing
6. Patients in stage 1 and 2 according to Hoehn yarr staging |
|
| ExclusionCriteria |
| Details |
1. Patients diagnosed with other degenerative
progressive conditions like Dementia, Alzheimer’s
or with Parkinson plus syndrome
2. Patients who are unable to comprehend or follow
test instructions
3. Patients diagnosed with any other musculoskeletal or neurological condition that may affect or limit their ability to walk
4. Uncooperative or unwilling patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Functional gait assessment (FGA)
2. Unified Parkinson disease rating scale (UPDRS)
3. Parkinson disease fatigue scale
4. Freezing of gait questionnaire (FOG-Q)
5. Montreal cognitive assessment (MOCA)
6. Dual-Task Cost (DTC)
7. Four-Square Step Test (FSST) |
1. Functional gait assessment (FGA) Baseline
2. Unified Parkinson disease rating scale (UPDRS) Baseline
3. Parkinson disease fatigue scale Baseline
4. Freezing of gait questionnaire (FOG-Q) Baseline
5. Montreal cognitive assessment (MOCA) Baseline
6. Dual-Task Cost (DTC) Baseline
7. Four-Square Step Test (FSST) Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/08/2025 |
| 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
|
This study aims to investigate the multifactorial causes of gait disturbances in individuals diagnosed with Parkinson’s disease. Parkinson’s disease is a progressive neurodegenerative disorder characterized by both motor symptoms such as rigidity, bradykinesia, tremor, and postural instability and non motor symptoms, including fatigue, cognitive impairment, and autonomic dysfunction. Among these, gait impairment is a prominent and early feature that significantly affects mobility, independence, and quality of life in patients. The study focuses on evaluating how various motor and non motor factors specifically rigidity, bradykinesia, fatigue, cognitive decline, freezing of gait, dual-task cost, and balance dysfunction that contribute to altered gait patterns in PD. Each of these parameters individually and collectively influences spatial and temporal aspects of gait such as stride length, gait speed, and coordination. The novelty of this study lies in its comprehensive and comparative analysis of all these variables, rather than evaluating them in isolation. Through the use of validated assessment tools like the Functional Gait Assessment, UPDRS, MOCA, FOG Questionnaire, Parkinson disease fatigue scale, FSST and DTC. The study aims to identify the most influential factors affecting gait performance. The expected outcome is to inform rehabilitation strategies that address the most critical determinants of gait dysfunction early in the disease course, thereby enhancing therapeutic effectiveness and improving patient outcomes. |