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CTRI Number  CTRI/2024/07/069854 [Registered on: 03/07/2024] Trial Registered Prospectively
Last Modified On: 24/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Observational study 
Study Design  Single Arm Study 
Public Title of Study   Standardising Method For Reactive Lateral Stepping 
Scientific Title of Study   Inter and Intra-rater differences in the extent of lean release and its influence on lateral-stepping characteristics 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohammed Iqbal Farooq J 
Designation  Post Graduate Student 
Affiliation  Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) 
Address  1st floor, Department of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai

Chennai
TAMIL NADU
600116
India 
Phone  9150155729  
Fax    
Email  iqbalfarooq2000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Praveen Kumar C R 
Designation  Assistant Professor  
Affiliation  Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) 
Address  Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai

Chennai
TAMIL NADU
600116
India 
Phone  9445334017  
Fax    
Email  praveenkumar.cr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mohammed Iqbal Farooq J 
Designation  Post Graduate Student 
Affiliation  Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) 
Address  1st floor, Department of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai

Chennai
TAMIL NADU
600116
India 
Phone  9150155729  
Fax    
Email  iqbalfarooq2000@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Mohammed Iqbal Farooq J 
Address  Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu, India. 
Type of Sponsor  Other [Self Funding] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mohammed Iqbal Farooq J  Sri Ramachandra Institute of Higher Education and Research (Deemed to be University)  1st floor, Department of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu, India.
Chennai
TAMIL NADU 
9150155729

iqbalfarooq2000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Ramachandra institution of higher education and research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  1. Normal population age 18 – 26 years 2. Both Male and Female 3. Willing to participate in the study 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  26.00 Year(s)
Gender  Both 
Details  1. Normal population age 18 – 26 years
2. Both Male and Female
3. Willing to participate in the study 
 
ExclusionCriteria 
Details  1. Individuals with a history of musculoskeletal or neurological disorders
2. Subjects who have any medical conditions or physical impairments that could interfere with their ability to stand or walk without assistance
3. Recent surgical history
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Balance Evaluation Systems Test  single baseline measurement 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   05/07/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Falls can be prevented by compensating postural reactions to maintain balance. Reactive postural control maintains the centre of mass within the base of support during destabilizing perturbations (Sibley et al., 2013). Ageing affects balance control during walking, but research has focused on the sagittal plane, with limited examination of frontal plane disturbances in older adults (Afschrift et al., 2019). In postural control assessment, people may use a stepping strategy to maintain balance. It involves taking steps when balance is lost or perturbations occur, serving as a compensatory mechanism. Lateral disturbances impose unique demands on mediolateral protective stepping compared to anteroposterior (A-P) stepping. (Maki et al., 1996). A lateral disturbance while standing still causes the Center of Mass (COM) to shift, leading to a redistribution of weight under each leg. The leg on the opposite side of the fall becomes passively unloaded, allowing for a quicker foot lift-off and reducing the need for weight redistribution when stepping (Mille et al., 2005). Compensatory lateral stepping correction is a key element of the reactive postural response assessed in the Balance Evaluation Systems Test (BESTest). This test measures an individual’s ability to recover balance by taking a lateral step when suddenly released from a lateral lean position. The extent of lean angle and its impact on lateral-stepping characteristics were not measured in any of the studies.

Research has shown that the leaning angle influences the stepping pattern, and more research is required to understand the spatiotemporal parameters and inter & intra-rater variability of stepping reactions in young adults.

The purpose of this study is to measure the spatiotemporal parameters and the inter- /intra-rater variability of lateral stepping, which is initiated by a release from lean in healthy young adults. The findings of this study will be beneficial for the clinical assessment and training of reactive postural control for lateral stepping.

 
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