| CTRI Number |
CTRI/2021/01/030280 [Registered on: 06/01/2021] Trial Registered Prospectively |
| Last Modified On: |
05/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of square stepping exercise on memory, thinking and risk of fall in post-menopausal women |
|
Scientific Title of Study
|
Effect of square stepping exercise on cognition and risk of fall in post-menopausal women |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikita S Rathi |
| Designation |
Post graduate student |
| Affiliation |
Dr.D.Y.Patil college of Physiotherapy |
| Address |
PG-2 Classroom 3rd floor, Dr.D.Y.Patil college of Physiotherapy
Sant Tukaram Nagar, Pmpri,
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7874945195 |
| Fax |
|
| Email |
nikirathi0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa Desai |
| Designation |
Associate professor |
| Affiliation |
Dr.D.Y.Patil college of Physiotherapy |
| Address |
Department of Musculoskeletal,
3rd Floor,
Dr.D.Y.Patil College of Physiotherapy
Sant Tukaram Nagar, Pimpri,
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
|
| Fax |
|
| Email |
roopa.desai@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Nikita Rathi |
| Designation |
Post graduate student |
| Affiliation |
Dr.D.Y.Patil college of Physiotherapy |
| Address |
PG-2 Classroom 3rd floor, Dr.D.Y.Patil college of Physiotherapy
Sant Tukaram Nagar, Pmpri,
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7874945195 |
| Fax |
|
| Email |
nikirathi0@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y.Patil college of physiotherapy , pimpri ,pune. |
|
|
Primary Sponsor
|
| Name |
NikitaSRathi |
| Address |
A-6 603 Swarganga society vallabh nagar pimpri pune |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Nikita S Rathi |
Dr.D.Y.Patil College of Physiotherapy |
4th Floor CBR Department of Dr.D.Y.Patil College Of Physiotherapy
Pune
MAHARASHTRA |
7874945195
nikirathi0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Post-menopausal women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physiotherapy training |
Warm up exercises would be given for 5 minutes.
Week 1: Static balance exercises like Romberg’s exercise with moderate to minimal support, standing marches, supported squatting (with chair), heel raises without holds. All exercises will be performed for 5 times repetitions.
Week 2:Exercises like Romberg’s exercise without support squatting with minimal support, heel raises with holds, side walking, one leg standing. All exercises will be performed for 5 times repetitions.
Week 3:Exercises like squatting without support, toe walking, side walking, ball catching exercises, one leg standing. All exercises will be performed for 5 times repetitions.
Week 4:Exercises like walking while carrying a ball, stepping over obstacle, tandem walking, backward walking. All exercises will be performed for 5 times repetitions.
COOL DOWN
The execution rhythm becomes progressively slower.
All these exercises will be performed five times a week, for 4 weeks for 30 minutes.
|
| Intervention |
Square Stepping exercise |
Warm up exercises would be given for 5 minutes.
Week 1: Level 1 SSE with 5 times repetitions and can be progressed by toe walking.
Week 2: Progression by level 2 with 5 times repetitions and can be progressed by toe walking.
Week 3: Progression by level 3 with 5 times repetitions and can be progressed by toe walking.
Week 4: Progression by level 4 with 5 times repetitions and can be progressed by toe walking.
COOL DOWN The execution rhythm becomes progressively slower. All these exercises will be performed five times a week, for 4 weeks for 30 minutes.
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Mini Mental State Examination score >24
Bergs Balance Scale scores more than 41/56
|
|
| ExclusionCriteria |
| Details |
Any neurological disease
Musculoskeletal impairment like severe joints pain in lower extremity or any recent injuries in lower limb <3 months.
Severe Balance impairment
Unstable cardio-respiratory condition
Recent fractures of lower extremity
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Bergs Balance Scale
Montreal Cognitive Assessement |
On the first day , post 2-weeks and end of 4-weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
12/01/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TITLE:-“EFFECT OF SQUARE STEPPING EXERCISE ON COGNITION AND RISK OF FALL IN POST-MENOPAUSAL WOMEN†OBJECTIVES:- 1. To find the effect of square stepping exercise on cognition and risk of fall in post-menopausal women. 2. To find the effect of conventional physiotherapy exercises on cognition and risk of fall in post-menopausal women. 3. To compare the effects of square stepping exercise and conventional physiotherapy training in post-menopausal women. METHODOLOGY :- GROUP A- The session will be started with warm up exercises followed by square stepping exercise followed by cool down. GROUP B- The session will be started with warm up exercise followed by conventional physiotherapy training followed by cool down. Treatment would be given for 5 days a week for 4 weeks for 30 mins per session. |