| CTRI Number |
CTRI/2024/10/075964 [Registered on: 28/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Dynamic balance and lower limb strength relation within fallers in a community older individuals. |
|
Scientific Title of Study
|
Relation between Dynamic Balance and Lower Limb Strength among Fallers in Community Elderly Individuals – A Cross sectional study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohini VSarode |
| Designation |
1 st year MPT (Community physiotherapy) |
| Affiliation |
Dr Vithalrao Vikhe Patil college of physiotherapy Ahmednagar |
| Address |
Department of Community Physiotherapy Basement Dr Vithalrao
Vikhe Patil college of physiotherapy vilad ghat Ahmednagar
Ahmadnagar MAHARASHTRA 414111 India
Ahmadnagar
MAHARASHTRA
414111
India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
08856996285 |
| Fax |
|
| Email |
rohinisrode300@gamil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyam D Ganvir |
| Designation |
Principal & Professor Department of Community Physiotherapy |
| Affiliation |
Dr Vithalrao Vikhe Patil college of physiotherapy Ahmednagar |
| Address |
Department of community physiotherapy basement Dr Vithalrao
Vikhe Patil college of physiotherapy Ahmednagar Ahmadnagar
MAHARASHTRA 414111 India
Ahmadnagar
MAHARASHTRA
414111
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9373566683 |
| Fax |
|
| Email |
shyam.ganvir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shyam D Ganvir |
| Designation |
Principal & Professor Department of Community Physiotherapy |
| Affiliation |
Dr Vithalrao Vikhe Patil college of physiotherapy Ahmednagar |
| Address |
Department of community physiotherapy basement Dr Vithalrao
Vikhe Patil college of physiotherapy Ahmednagar Ahmadnagar
MAHARASHTRA 414111 India
Ahmadnagar
MAHARASHTRA
414111
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9373566683 |
| Fax |
|
| Email |
shyam.ganvir@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DVVPFS College of Physiotherapy Ahmednagar |
| Address |
Dr Vithalrao Vikhe Patil college of physiotherapy opposite govt milk dairy midc vild ghat Ahmednagar -414111 |
| 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 Shyam D Ganvir |
DVVPFS College of physiotherapy vild ghat Ahmadnagar |
Department of community physiotherapy basement Dr Vithalrao vikhe patil college of physiotherapy Ahmadnagar MAHARASHTRA 414111 India
Ahmadnagar
MAHARASHTRA |
9373566683
shyam.ganvir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DVVPFs college of physiotherapy institutional ethical commitee Ahmednagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
fall in elderly population |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1.Have Fall history 1 year
2.Participant who are able to give informed consent in the study.
|
|
| ExclusionCriteria |
| Details |
I.Previous hip surgery like lower extremity joint replacement ,Serious injury within 6 months to lower limb
II.Rheumatoid, or any neurological condition like stroke, Parkinson, multiple sclerosis/dementia/psychosis/unconscious patients, emergency patients.
III.Prostheses
IV.Individual did not walk independently
V.Those who are not able to attend ideal position for test |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Y balance scale
Smart Electronic Scale |
Immediately |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
15/11/2024 |
| 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)
|
Open to Recruitment |
| 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
|
A number of variables, both extrinsic (related to the environment) and intrinsic (related to the person), lead to falls in the senior population. However, some older people fall even when they have no neurological conditions or environmental barriers. Therefore, the aim of this research is to determine the association between lower limb muscle strength and dynamic balance in those who fall among the senior community population. |