| CTRI Number |
CTRI/2026/03/106463 [Registered on: 18/03/2026] Trial Registered Prospectively |
| Last Modified On: |
15/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Stability and chances of falling in young females with irregular periods |
|
Scientific Title of Study
|
Correlation between static and dynamic balance with the risk of fall in young females with Irregular Menstruation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nishu Kumari |
| Designation |
Undergraduate student |
| Affiliation |
Maharishi Markandeshwar Institute Of Physiotherapy and Rehabilitation |
| Address |
Room no 306,Second floor, Hostel no 7,Near Maharishi Markandeshwar Institute Of Physiotherapy and Rehabilitation,Maharishi Markandeshwar (Deemed to be)University,Mullana-Ambala,Haryana
Ambala HARYANA 133203 India |
| Phone |
8544636021 |
| Fax |
|
| Email |
nishukumari9112@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Etika Rana |
| Designation |
Assistant professor |
| Affiliation |
Maharishi Markandeshwar Institute Of Physiotherapy and Rehabilitation |
| Address |
Chamber number 4,Maharishi Markandeshwar Institute Of Physiotherapy and Rehabilitation,Maharishi Markandeshwar (Deemed to be)University,Mullana-Ambala,Haryana
Ambala HARYANA 133203 India |
| Phone |
7018232435 |
| Fax |
|
| Email |
etikarana777@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Etika Rana |
| Designation |
Assistant professor |
| Affiliation |
Maharishi Markandeshwar Institute Of Physiotherapy and Rehabilitation |
| Address |
Chamber number 4,Maharishi Markandeshwar Institute Of Physiotherapy and Rehabilitation,Maharishi Markandeshwar (Deemed to be)University,Mullana-Ambala,Haryana
Ambala HARYANA 133203 India |
| Phone |
7018232435 |
| Fax |
|
| Email |
etikarana777@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation,Maharishi Markandeshwar (Deemwed to be) University,MUllana-Ambala,Haryana 133207 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Etika Rana |
Chamber number 4,Maharishi Markandeshwar Institute Of Physiotherapy and Rehabilitation,Maharishi Markandeshwar (Deemed to be)University,Mullana-Ambala,Haryana |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Etika Rana |
Maharishi Markandeshwar Institute of Physiotherapy Mullana Ambala |
Chamber no 4
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be)University Mullana Ambala Haryana 133207 Ambala HARYANA |
7018232435
etika777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE,MAHARISHI MARKANDESHWAR INSTITUTE OF MEDICAL SCIENCE AND RESEARCH,MULLANA,AMBALA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Irregular menstruation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Females with irregular menstruation, included in the study, defined by at least one of following as per ACOG and FIGO criteria
Unmarried females
participants who give their consent voluntarily for participation. |
|
| ExclusionCriteria |
| Details |
Married females
Participants with recent lower limb fracture or injury
Participants with neurological, musculoskeletal or any other systemic illness
Participants with vestibular disorder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Single leg stance
2 Four square step test
3 Modified fall efficacy scale |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="124" Sample Size from India="124"
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)
|
26/03/2026 |
| 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 Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nishukumari9112@gmail.com].
- For how long will this data be available start date provided 28-03-2026 and end date provided 01-09-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study focuses on examining the correlation between static and dynamic balance and the risk of fall in young females with irregular menstruation. Menstrual irregularities are commonly associated with hormonal fluctuations, particularly variations in estrogen and progesterone levels, which may influence the functioning of the musculoskeletal and nervous systems. These hormonal changes can affect muscle strength, proprioception, ligament laxity, and neuromuscular coordination, all of which play an important role in maintaining postural stability and balance. Any impairment in these factors may lead to decreased balance control and may increase the likelihood of falls or fear of falling during daily activities. To evaluate these aspects, the study assesses static balance using the Single Leg Stance Test, which measures an individual’s ability to maintain stability while standing on one leg without support. Dynamic balance is assessed using the Four Square Step Test, which evaluates the ability to change directions and maintain balance while stepping over obstacles. In addition, the risk of fall is measured using the Modified Fall Efficacy Scale MFES, a validated questionnaire that assesses an individual’s confidence in performing various functional and daily activities without falling. By analyzing the relationship between these variables, the study aims to determine whether reduced static and dynamic balance is associated with an increased perceived risk of falls in young females with irregular menstruation. Understanding this relationship may help in the early identification of balance deficits in this population and may contribute to the development of appropriate physiotherapy interventions and preventive strategies to improve balance, enhance functional stability, and reduce the risk of falls. |