| 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
|
|
|
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
|
|
|
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. |