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CTRI Number  CTRI/2024/09/073726 [Registered on: 10/09/2024] Trial Registered Prospectively
Last Modified On: 07/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Normative Study 
Study Design  Other 
Public Title of Study   Normative Values of Oblique Direction Reach Test  
Scientific Title of Study   Normative Value of Oblique Direction Rech Test (ODRT) In Healthy Adults: An Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Purvi D Amin 
Designation  Master of Physiotherapy Student 
Affiliation  Institute of physiotherapy, Srinivas University  
Address  Department of Physiotherapy, Institute of Physiotherapy, Srinivas University, Pandeshwar, Mangalore, Dakshina Kannada, Karnataka

Dakshina Kannada
KARNATAKA
575001
India 
Phone  8347980539  
Fax    
Email  purviamin103@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Thrishala Noronha 
Designation  Associate professor 
Affiliation  Institute of physiotherapy, Srinivas University 
Address  Department of Physiotherapy, Institute of Physiotherapy, Srinivas University, Pandeshwar, Mangalore, Dakshina Kannada, Karnataka

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9743201400  
Fax    
Email  thrish22.cp@srinivasuniversity.edu.in  
 
Details of Contact Person
Public Query
 
Name  Purvi D Amin 
Designation  Master of Physiotherapy Student 
Affiliation  Institute of physiotherapy, Srinivas University 
Address  Department of Physiotherapy, Institute of Physiotherapy, Srinivas University, Pandeshwar, Mangalore, Dakshina Kannada, Karnataka

Dakshina Kannada
KARNATAKA
575001
India 
Phone  08347980539  
Fax    
Email  purviamin103@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Institute of Physiotherapy, Srinivas University, Pandeshwar, Mangalore, Karnataka, 575001 
 
Primary Sponsor  
Name  Institute of Physiotherapy Srinivas University  
Address  Department of Physiotherapy, Institute of Physiotherapy, Srinivas University, Pandeshwar, Mangalore, Dakshina Kannada, Karnataka,575001  
Type of Sponsor  Research institution 
 
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 Purvi D Amin   Institute of Physiotherapy, Srinivas University   Department of Physiotherapy, Institute of Physiotherapy Srinivas University, Pandeshwar, Mangalore Dakshina Kannada, Karnataka, 575001
Dakshina Kannada
KARNATAKA 
08347980539

purviamin103@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRINIVAS UNIVERSITY ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Adults 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Age group 20-80 years
Both genders 
 
ExclusionCriteria 
Details  People with any underlying neurological,
cardiovascular conditions, and musculoskeletal conditions.
Any history of back and lower extremity surgery
Structural deformities
Visual and vestibular disorders
Limb length discrepancy more than 1.5 to 2 CMS
History of Abdominal surgery. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Oblique Direction Reach Test   Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   20/09/2024 
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="1"
Months="0"
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  
Study titled "Normative Values of Oblique Direction Reach Test (ODRT) in Healthy Adults: An Observational Study." Here’s a brief summary:

Objective and Aim:
The study aims to establish normative values for the Oblique Direction Reach Test (ODRT) in healthy adults aged 20-80 years. This test measures an individual’s ability to maintain balance and stability while reaching in an oblique direction, which is relevant for everyday activities.

Background:
Balance is crucial for daily life and involves maintaining the center of mass within the base of support. Dynamic balance requires movement and adjustment of the body’s center of gravity. Various factors, including age and neurological conditions, can impact balance. The ODRT assesses balance by measuring how far individuals can reach in an oblique direction without losing stability. The study’s goal is to provide reference values for different age groups, which could help healthcare professionals better assess and treat balance impairments.

Methodology: 
Study Design: Observational study.
Participants: Healthy adults aged 20-80 years.
Sampling Method: Purposive sampling.
Procedure: Participants will perform the ODRT, where they will stand and reach as far as possible in an oblique direction without moving their feet or losing balance. The distance reached will be measured and recorded.
Data Analysis: Data will be analyzed using statistical methods to determine normative values and any correlations between age, gender, and ODRT performance.

Significance:
The study could provide valuable insights for assessing balance and stability in clinical settings, particularly for adults, and contribute to developing interventions to prevent falls and improve postural control.

This research is being conducted as part of the author’s master’s program in Physiotherapy at Srinivas University.
 
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