| 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
|
|
|
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
|
|
|
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
|
|
|
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. |