| CTRI Number |
CTRI/2021/02/031365 [Registered on: 17/02/2021] Trial Registered Prospectively |
| Last Modified On: |
05/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find the extent of fear of falling and balance issues among elderly residing in community at selected areas of Kozhikode |
|
Scientific Title of Study
|
Evaluation of Fear of Fall and Dynamic Balance among Community Dwelling Elderly in Selected areas of Kozhikode |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Binoy Mathew K V |
| Designation |
Lecturer Physiotherapy |
| Affiliation |
Composite Regional Centre,Kozhikode |
| Address |
Department of Physiotherapy
IMHANS Campus
Medical College PO
Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
9633115601 |
| Fax |
|
| Email |
binoy9797@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Binoy Mathew K V |
| Designation |
Lecturer Physiotherapy |
| Affiliation |
Composite Regional Centre,Kozhikode |
| Address |
Department of Physiotherapy
IMHANS Campus
Medical College PO
Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
9633115601 |
| Fax |
|
| Email |
binoy9797@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Binoy Mathew K V |
| Designation |
Lecturer Physiotherapy |
| Affiliation |
Composite Regional Centre,Kozhikode |
| Address |
Department of Physiotherapy
IMHANS Campus
Medical College PO
Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
9633115601 |
| Fax |
|
| Email |
binoy9797@gmail.com |
|
|
Source of Monetary or Material Support
|
| Composite Regional Centre Kozhikode
IMHANS Campus
Medical College P.O
Kozhikode
Kerala
PIN:673008
|
|
|
Primary Sponsor
|
| Name |
CRC Kozhikode |
| Address |
IMHANS Campus
Medical College PO
Kozhikode |
| Type of Sponsor |
Other [Government Institution] |
|
|
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 |
| Binoy Mathew K V |
Composite Regional Centre - Kozhikode |
Department of Physiotherapy
Composite Regional Centre - Kozhikode
IMHANS Campus
Medical College P.O
Kozhikode
Kerala
PIN:673008
Kozhikode
KERALA |
9633115601
binoy9797@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IMHANS ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Elderly residing in community |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Community-dwelling elderly above 60-year-old residing in ward 17 of Calicut Corporation
2.Ability to ambulate with/without assistive aids
3.Willingness to participate in the study |
|
| ExclusionCriteria |
| Details |
1.Elderly who are confined to bed due to neuromusculoskeletal disorders
2.Inability to follow the instructions due to cognitive impairment
3.Restriction for physical exertion due to cardio-respiratory risk factors
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fear of Falling
Dynamic Balance |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in number of falls |
1 year |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
01/04/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The research study aims to evaluate the extent of fear of falling and balance issues among the elderly in Kozhikode. Balance issues and fear of falling are the main concern among the elderly leading to falls. Awareness generation and remedial measures will be planned based on the study findings. The study will be conducted adhering to ethical principles and following pandemic-related governmental guidelines. |