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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  
NIL 
 
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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [nishukumari9112@gmail.com].

  6. 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.

  7. 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.
 
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