| CTRI Number |
CTRI/2026/01/102581 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing balance and risk of falling among elderly people in a selected community area of Wardha. |
|
Scientific Title of Study
|
Assess the balance and fall risk among geriatric population in the selected community area of Wardha. |
| 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 Pratiksha Kirde |
| Designation |
PG nursing student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Wardha |
| Address |
Dept. Of Medical Surgical Nursing 1st floor Smt. Radhikabai Meghe Memorial College of Nursing Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9511699757 |
| Fax |
|
| Email |
pratikshakirde.08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSheetal Sakharkar |
| Designation |
Asst. Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Wardha |
| Address |
Dept. Of Medical Surgical Nursing 1st floor Smt. Radhikabai Meghe Memorial College of Nursing Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8830805434 |
| Fax |
|
| Email |
sheetalmude14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSheetal Sakharkar |
| Designation |
Asst. Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Wardha |
| Address |
Dept. Of Medical Surgical Nursing 1st floor Smt. Radhikabai Meghe Memorial College of Nursing Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8830805434 |
| Fax |
|
| Email |
sheetalmude14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe Wardha Maharashtra India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha Maharashtra India 442001 |
| Type of Sponsor |
Private 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 Sheetal Sakharkar |
Smt. Radhikabai Meghe Memorial College of Nursing Sawangi Meghe Wardha 442001 |
Dept. Of Medical Surgical Nursing 1st floor Smt. Radhikabai Meghe Memorial College of Nursing Sawangi Meghe Wardha
Wardha
MAHARASHTRA |
8830805434
sheetalmude14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Assessment of balance and fall risk of geriatric population scoring will be done with the help of berg balance scale in community area of Wardha |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals who can follow verbal commands and perform basic functional activities.
2. Individuals who give informed consent to participate.
|
|
| ExclusionCriteria |
| Details |
1. Elderly with severe cognitive impairment or neurological disorders (e.g., stroke, Parkinson’s disease).
2. Those with severe visual or auditory impairments.
3. Bedridden or critically ill patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Scores on fall risk among geriatric population |
Assessment will be done at 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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)
|
15/03/2026 |
| 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="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
|
This study focuses on assessing balance and fall risk among elderly people aged 60 years and above living in a selected community area of Wardha. With increasing age, changes such as reduced muscle strength, poor coordination, and vision problems can affect balance and increase the risk of falls. Falls are a common cause of injury and loss of independence among the geriatric population. The berg balance scale (BBS)used as the main assessment tool in this study. It is a simple and standardized scale that consists of ,14 activities such as standing, sitting, turning, and reaching, which are commonly performed in daily life. Each activity is scored from 0 to 4, with a total score ranging from 0 to 56. Lower scores indicate poor balance and higher risk of falls, while higher scores indicate better balance and lower fall risk. |