| CTRI Number |
CTRI/2024/07/070383 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Standarizing method for reactive forward stepping. |
|
Scientific Title of Study
|
Inter and Intra-rater differences in the extent of lean release and its influence on forward-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 |
V Padmavathi |
| Designation |
MPT Student |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Sri Ramachandra Institute Of Higher Education And Research no 1, Sri Ramachandra Nagar,Porur,Iyyapanthangal, Chennai-116
Chennai
TAMIL NADU
600116
India |
| Phone |
9080154837 |
| Fax |
|
| Email |
padmajanani101@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
C R Praveen Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Sri Ramachandra Institute Of Higher Education And Research Sri Ramachandra Faculty of Physiotherapy, 1st floor no 1,Sri Ramachandra Nagar, Iyyapanthangal porur,chennai-116
Chennai
TAMIL NADU
600116
India |
| Phone |
9445334017 |
| Fax |
|
| Email |
praveenkumar.cr@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
C R Praveen Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Sri Ramachandra Institute Of Higher Education And Research Sri Ramachandra Faculty of Physiotherapy, 1st floor no 1,Sri Ramachandra Nagar, Iyyapanthangal porur,chennai-116
Chennai
TAMIL NADU
600116
India |
| Phone |
9445334017 |
| Fax |
|
| Email |
praveenkumar.cr@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute Of Higher Education And Research no 1, Sri Ramachandra Nagar,Iyyapanthangal,Porur, Chennai-600116
Tamil Nadu
India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| V PADMAVATHI |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be university) |
Sri Ramachandra Institute Of Higher Education And Research Sri Ramachandra Faculty of Physiotherapy, 1st floor no 1,Sri Ramachandra Nagar, Iyyapanthangal,porur,chennai-116
Chennai
TAMIL NADU |
9080154837
padmajanani101@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FOR STUDENTS PROJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NOT APPLICABLE |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
age 18-26 years both male and female willing to participate in the study |
|
| ExclusionCriteria |
| Details |
History of musculoskeletal injuries to upper and lower limbs
Gait impairment; severe arthritis; required cane or walker for ambulation
Recent surgical history
Neurological and cardiorespiratory problems |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Balance Evaluation System Test |
Single baseline measurement
observational study(one time observation) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/07/2024 |
| 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="0"
Days="14" |
|
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 occur as a result of a loss of balance while standing, but fortunately, they can be prevented through the use of appropriate compensatory postural reactions. Reactive postural control is a term that describes an individual’s capacity to maintain their center of mass (COM) within their base of support (BOS) when faced with an external destabilizing perturbation. These postural reactions occur quickly and rely on the integration of signals from the sensory systems. Reactive postural responses are broadly categorized into hip, ankle, and stepping strategies. The ankle strategy is the first to act when the perturbation is minor. The hip strategy is a response that is triggered when the base of support is limited and there is a large perturbation.This response occurs when the external force exceeds the human body’s ability to maintain its initial base of support. Stepping is the common strategy seen in the individual while performing posturalcontrol assessment in stance In this the maximum leaning angle leads to forward stepping causing a single step or rapid step to regain balance during forward fall. The postural control assessment should be done in a complex and dynamic context by applying a sudden external perturbation and simulate the loss of balance in individuals, to mimic a real-life fall situation. Various assessment strategies for reactive postural control are been used in clinical setting like Balance evaluation system test, waist pulls and surface translation, but the destabilizing forces or perturbations are different in all the methods mentioned above. Compensatory stepping correction – forward is a component of reactive postural response in the balance evaluation systems test (BESTest), which evaluates the balance recovery of a person by taking a forward stepping when there is a sudden release from forward lean by release from- lean method. Despite having various ways of reactive stepping evaluation, few studies measured the stepping threshold in populations such as diabetes and elderly people. Research has shown that the leaning angle influences the stepping pattern and research is required to understand the spatiotemporal parameters and inter and intra-rater variability of stepping reactions in young adults
|