| CTRI Number |
CTRI/2020/12/029634 [Registered on: 08/12/2020] Trial Registered Prospectively |
| Last Modified On: |
17/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Analytical |
| Study Design |
Other |
|
Public Title of Study
|
To see whether reduced foot and ankle muscles strength causes falls in elderly |
|
Scientific Title of Study
|
Foot and ankle muscles strength to predict falls among elderly |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shaharsha Borkar |
| Designation |
PG student Masters in neurophysiotherapy |
| Affiliation |
Sancheti institute college of physiotherapy |
| Address |
1st floor,Sancheti institute college of physiotherapy, 12, thube park, shivajinagar
Pune
MAHARASHTRA
411005
India |
| Phone |
9561472233 |
| Fax |
|
| Email |
shaharshaborkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Radha Bhattad |
| Designation |
Professor and head of department, Department of neurophysiotherapy |
| Affiliation |
Sancheti institute college of physiotherapy |
| Address |
1st floor,Sancheti institute college of physiotherapy, 12, thube park, shivajinagar
Pune
MAHARASHTRA
411005
India |
| Phone |
9860542511 |
| Fax |
|
| Email |
drradhabhattad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shaharsha Borkar |
| Designation |
PG student Masters in neurophysiotherapy |
| Affiliation |
Sancheti institute college of physiotherapy |
| Address |
1st floor, Sancheti institute college of physiotherapy, 12, thube park, shivajinagar
Pune
MAHARASHTRA
411005
India |
| Phone |
9561472233 |
| Fax |
|
| Email |
shaharshaborkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti institute college of physiotherapy |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Shaharsha Borkar PT |
Sancheti institute college of physiotherapy |
Basement floor, physiotherapy OPD, Sancheti.
Pune
MAHARASHTRA |
9561472233
shaharshaborkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Sancheti Institute Orthopaedics and Rehabilitation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Geriatric population |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
community dwelling healthy elderly individuals |
|
| ExclusionCriteria |
| Details |
Individuals with vestibular impairment, Visual impairment, Diabetic neuropathy, Lower limb fracture , Foot disease , Neurological problems or Any Vascular problems of lower limb. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Berg Balance Scale |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hand held dynamometer micro FET-3, Paper grip test, Intrinsic foot muscles test. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/12/2020 |
| Date of Study Completion (India) |
30/08/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a observational analytical study , assessing foot and ankle muscles strength in elderly using hand held dynamometer micro FET 3, paper grip test, intrinsic foot muscle test , for predicting falls using berg balance scale and also number of falls encounter during last one year. |