| CTRI Number |
CTRI/2024/11/077139 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between Fear of Fall and Dizziness in People with Parkinsons Disease. |
|
Scientific Title of Study
|
Relationship between Fear of Fall and Vestibular Dysfunction in Individuals 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 |
Aarohi Dani |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Upper Basement, Department of Physiotherapy, Manipal Hospital, No 98, Rustam Bagh, Old Airport Road, Bangalore, Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
9886647732 |
| Fax |
|
| Email |
dani.mhsblr2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Prem |
| Designation |
Additional Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Upper Basement, Department of Physiotherapy, Manipal Hospital, No 98, Rustam Bagh, Old Airport Road, Bangalore, Karnataka
560017
I
Bangalore
KARNATAKA
560017
India |
| Phone |
09886647732 |
| Fax |
|
| Email |
prem.v@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Prem |
| Designation |
Additional Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Upper Basement, Department of Physiotherapy, Manipal Hospital, No 98, Rustam Bagh, Old Airport Road, Bangalore, Karnataka
560017
I
Bangalore
KARNATAKA
560017
India |
| Phone |
09886647732 |
| Fax |
|
| Email |
prem.v@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Hospitals, Upper Basement, Department of Physiotherapy, Room No 98, Rustam Bagh, Old Airport Road, Bangalore, Karnataka
560017
India |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal Hospital #98, HAL, Old Airport Road, Bangalore, Karnataka, 560017 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrAarohi Dani |
Manipal Hospitals |
Upper Basement, Department of Physiotherapy, Manipal Hospital, Room No 98, Rustam Bagh, Old Airport Road, Bangalore, Karnataka
560017
India
Bangalore
KARNATAKA |
8329279105
dani.mhsblr2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Manipal Hospitals, Bangalore |
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 |
29.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals with Parkinsons disease with Hoen and Yahr stage 1-3. |
|
| ExclusionCriteria |
| Details |
1. Individuals with cognitive impairment as assessed by montral cognitive assessment.
2. Bedridden and unconscious patients.
Disorders such as stroke or myocardial infarction which could have caused weakness or instability in less than 3 months before inclusion.
3. A history of recent fracture or surgery of lower limbs. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Dizziness Handicap Inventory |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Montreal Cognitive Assessment
2. Fall Efficacy Scale |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="87"
Sample Size from India="87"
Final Enrollment numbers achieved (Total)= "87"
Final Enrollment numbers achieved (India)="87" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2024 |
| Date of Study Completion (India) |
20/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 (PD) is a chronic progressive neurological disorder. however, in India, there have been only a less research data available on PD showing a wide range of prevalence. Manifestation of PD primarily includes postural instability, bradykinesia, tremors, rigidity and gait dysfunction. As postural instability stands out as a significant symptom of PD, it is associated with vestibular dysfunction. Vestibular deficits are linked to falls therefore the impact on fear of fall in individuals with PD needs to be addressed. |