| CTRI Number |
CTRI/2026/02/104642 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Exploratory study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to find how much external force is needed to make a person take a protective step in four different directions. |
|
Scientific Title of Study
|
“An analysis of perturbation threshold stimulus required to elicit reactive stepping in four cardinal directions – an exploratory study” |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naveen kumar P |
| Designation |
Post graduate student |
| Affiliation |
Sn Ramachandra institute of Higher Education And Research |
| Address |
Department of neurosciences
Sri ramachandra faculty of physiotherapy,SRIHER
Chennai
TAMIL NADU
600116
India |
| Phone |
8838462853 |
| Fax |
091-44-24765995 |
| Email |
naveenkumarp2711@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sivakumar R |
| Designation |
Professor |
| Affiliation |
Sn Ramachandra institute of Higher Education And Research |
| Address |
Department of neurosciences
Sri ramachandra faculty of physiotherapy,SRIHER
Chennai
TAMIL NADU
600116
India |
| Phone |
9840068412 |
| Fax |
091-44-24765995 |
| Email |
rsivkumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sivakumar R |
| Designation |
Professor |
| Affiliation |
Sn Ramachandra institute of Higher Education And Research |
| Address |
Department of neurosciences
Sri ramachandra faculty of physiotherapy,SRIHER
Chennai
TAMIL NADU
600116
India |
| Phone |
9840068412 |
| Fax |
091-44-24765995 |
| Email |
rsivkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Naveen kumar P |
| Address |
Ramachandra Medical College, Trunk Rd, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116 |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| Naveen kumar p |
Department of physiotherapy Sri Ramachandra faculty of physiotherapy |
Sri ramachandra faculty of physiotheray ,SRIHER
Chennai
TAMIL NADU |
8838462853
naveenkumarp2711@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
student population |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
age from 18 to 25years young adult
both male and female included |
|
| ExclusionCriteria |
| Details |
History of musculoskeletal injuries to upper and lower limbs.
Neurological and cardiorespiratory problems that can influence the outcome of the study .
Recent surgical history
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Balance |
Balance |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reactive stepping |
|
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
15/03/2026 |
| 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="2"
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
|
Balance is defined as the ability to maintain the body’s center of mass within the base of support to ensure both stability and orientation. When the center of mass moves beyond this base and cannot be restored through ankle or hip strategies, reactive or compensatory stepping serves as the final protective response to prevent a fall. Maki and McIlroy (1999) emphasized that reactive stepping is essential for balance recovery in daily life, and age-related impairments in this mechanism significantly increase fall risk. Research indicates that the direction of perturbation plays a key role in balance recovery. Mille et al. (2013) found that older adults are more susceptible to lateral and backward perturbations compared to forward ones, suggesting that perturbation direction affects reactive stepping efficiency and fall avoidance. Similarly, Batcir et al. (2020) and Pai et al. (1998) demonstrated that the threshold required to elicit reactive stepping varies according to perturbation direction. Different experimental models have been developed to induce reactive stepping. The waist-pull method (Pai et al., 1998) has been commonly used but may not replicate real-world balance disturbances. In contrast, surface translation techniques—as employed by Batcir et al. (2020) and Muthukumar et al. (2025)—utilize moving platforms or treadmills that simulate natural perturbations more effectively. These studies also introduced the concept of using a percentage of body weight as a threshold to standardize stimulus intensity. Understanding threshold variations across directions can provide valuable insights for balance assessment and direction-specific rehabilitation. Therefore, the present study aims to determine the threshold stimulus (as a percentage of body weight) required to induce reactive stepping in forward, backward, and lateral directions using a moving platform. |