| CTRI Number |
CTRI/2021/11/037833 [Registered on: 08/11/2021] Trial Registered Prospectively |
| Last Modified On: |
05/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF different balance exercises on Falls in Elderly |
|
Scientific Title of Study
|
COMPARISON OF SQUARE STEPPING EXERCISES AND FOAM STABILITY EXERCISES ON FALLS IN COMMUNITY DWELLING ELDERS. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
dr Seemab khan |
| Designation |
Professor |
| Affiliation |
MUHS,Nashik,Maharashtra |
| Address |
dept of community PT.1st floor M A Rangoonwala College of physiotherapy 2390, K.B HIDAYATULLAH ROAD,Pue
K B HiDayatullah RoadGATE NUMBER 4, AZAM CAMPUS, CAMP
Pune
MAHARASHTRA
411001
India |
| Phone |
09822676725 |
| Fax |
020-26437871 |
| Email |
dr.seemab.khan@azamcampus.org |
|
Details of Contact Person
Scientific Query
|
| Name |
dr Seemab khan |
| Designation |
Professor |
| Affiliation |
MUHS,Nashik,Maharashtra |
| Address |
Dept of community PhysiotherapyM A Rangoonwala College of physiotherapy 2390, K.B HIDAYATULLAH ROAD,
.K B hidayatulla road,GATE NUMBER 4, AZAM CAMPUS, CAMP
Pune
MAHARASHTRA
411001
India |
| Phone |
09822676725 |
| Fax |
020-26437871 |
| Email |
dr.seemab.khan@azamcampus.org |
|
Details of Contact Person
Public Query
|
| Name |
dr Seemab khan |
| Designation |
Professor |
| Affiliation |
MUHS,Nashik,Maharashtra |
| Address |
M A Rangoonwala College of physiotherapy 2390, K.B HIDAYATULLAH ROAD,
Dept of community physiotherapy.GATE NUMBER 4, AZAM CAMPUS, CAMP
Pune
MAHARASHTRA
411001
India |
| Phone |
09822676725 |
| Fax |
020-26437871 |
| Email |
dr.seemab.khan@azamcampus.org |
|
|
Source of Monetary or Material Support
|
| self sponsored
M A Rangoonwala college of Physioherapy,Pune |
|
|
Primary Sponsor
|
| Name |
no sponsorship |
| 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 Seemab Khan |
M A Rangoonwala college of Physiotherapy |
k b hidayatullah road,azam campus camp Pune
Pune
MAHARASHTRA |
9822676725
020-26437871
dr.seemab.khan@azamcampus.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M.A.Rangoonwala college of Physiotherapy ,Institutes ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Elderly |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
foam stability exercise,5 days in week for four weeks |
these exercises are done on the unstable surface involving the foam platform |
| Comparator Agent |
square stepping exercise |
these exercises to be done in the multiple directions will be done for 5 days in week for four weeks |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Community-dwelling elderly, both males and females who were able to walk with or without an assistive device, having fear of fall with a score 16 - 27 on Falls Efficacy Scale International (FES-I) Questionnaire |
|
| ExclusionCriteria |
| Details |
participants recieving PT management for falls ,having any other neuromusculoskeletal complications will be excluded |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Bergs Balance Scale
2. Falls Efficacy Scale International Questionnaire |
four weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. Falls Efficacy Scale International Questionnaire |
four weeks |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
20/12/2021 |
| 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="0"
Months="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Background: Increased risk of falls in the elderly leads to activity restriction eventually causing the capacity decline and further falls. This is a vicious cycle and needs to be addressed with the multidisciplinary approach as significant improvement results in the reduction of falls. Objectives: To compare the effect of Square Stepping Exercises and Foam Stability Exercises on Risk of Fall using Berg’s Balance Scale and Fear of Fall using Falls Efficacy scale International Questionnaire. Materials and methodology: sixty-six community-dwelling elderly of Pune city, India, aged above 65yeas will be included in the study. All participants will be divided equally into two groups. Group 1 will be receiving Foam Stability Exercises and Group 2 will receive Square Stepping exercises 5 times a week for 4 weeks. Berg Balance Scale will be used to assess the risk of fall and Fall Efficacy Scale - international for assessing fear of fall. Outcome measures will be taken pre and after four weeks of intervention |