| CTRI Number |
CTRI/2024/04/066304 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to check balance and the capability to perform daily living tasks in women after their menstrual cycles stop |
|
Scientific Title of Study
|
Screening for postural balance and functional capacity among post menopausal women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Miss Saee Abhijit Sahasrabudhe |
| Designation |
MPT student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room no. 215
Department of Physiotherapy
Second floor,
Manipal College of Health Professions
Manipal Academy of higher education
Madhav Nagar
Manipal- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8108229876 |
| Fax |
|
| Email |
saee.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Miss Saee Abhijit Sahasrabudhe |
| Designation |
MPT student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room no. 215
Department of Physiotherapy
Second floor,
Manipal College of Health Professions
Manipal Academy of higher education
Madhav Nagar
Manipal- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8108229876 |
| Fax |
|
| Email |
saee.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Miss Saee Abhijit Sahasrabudhe |
| Designation |
MPT student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room no. 215
Department of Physiotherapy
Second floor,
Manipal College of Health Professions
Manipal Academy of higher education
Madhav Nagar
Manipal- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8108229876 |
| Fax |
|
| Email |
saee.mchpmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Room 216, Department of physiotherapy, 2nd floor,
Manipal college of Health Professions
Manipal academy of higher education
Manipal 576104
Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Manipal College Of Health Professions |
| Address |
Room 215, Department of physiotherapy, 2nd floor,
Manipal college of Health Professions
Manipal academy of higher education
Manipal 576104
Karnataka
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 G Arun Maiya |
Kasturba Hospital |
Room Number 1, Center for diabetic foot care and research, Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka
Udupi
KARNATAKA |
9845350823
arun.maiya@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Research Committe - 2 (student research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N959||Unspecified menopausal and perimenopausal disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Post-menopausal women |
|
| ExclusionCriteria |
| Details |
individuals with vestibular disorders, musculoskeletal disorders, and cardiovascular disorders, use of walking aids, comorbidities such as Diabetes mellitus, Hypertension, Use of steriods |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
postural balance
The Fullerton Advanced balance test measures postural balance by exposing the participant to various levels of instability. It gives a total score out of 40, the higher the score the better the balance is present.
Stabilometric Assessment
It is a posturography tool to assess the static balance of an individual by calculating the static postural sway in the X and Y axis.
Functional capacity
The Fullerton Functional Fitness test is a test battery with 6 tests included. it includes the arm curl test, the back scratch test, the rising up from a chair test, the chair sit and reach test, the 8 feet trial and the 6 minute walk test, which measures the physical capacities such as strength, flexibility and cardiorespiratory endurance
|
One time - baseline assessment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="78" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2024 |
| Date of Study Completion (India) |
29/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
There is dearth in the literature focusing specifically on balance impairment in post-menopausal women among Indian population, and is under-reported. Postural instability and reduced muscle strength can expose post-menopausal women to frequent falls, which can further lead to fractures due to osteoporosis. If balance and functional capacity is found to be impaired, screening of these components can be included as an integral part of physiotherapy assessment of post menopausal women. |