| CTRI Number |
CTRI/2023/08/055975 [Registered on: 01/08/2023] Trial Registered Prospectively |
| Last Modified On: |
25/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Validity and reliability of weight bearing lunge test with goniometer |
|
Scientific Title of Study
|
Concurrent validity and test re-test reliability of modified weight bearing lunge test using goniometer in asymptomatic individuals |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saroj Kumar Das |
| Designation |
Lecturer |
| Affiliation |
Alvas College of Physiotherapy and Research Centre |
| Address |
Alvas College of Physiotherapy and Research Centre
AHC Complex, Moodubidire, DK,
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9789906015 |
| Fax |
|
| Email |
hhsphysicaltherapist@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hariharasudhan Ravichandran |
| Designation |
Professor |
| Affiliation |
Alvas College of Physiotherapy and Research Centre |
| Address |
Department of Physiotherapy
Alvas College of Physiotherapy and Research Centre
AHC Complex, Moodubidire, DK
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9789906015 |
| Fax |
|
| Email |
hrkums63@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hariharasudhan Ravichandran |
| Designation |
Professor |
| Affiliation |
Alvas College of Physiotherapy and Research Centre |
| Address |
Department of Physiotherapy
Alvas College of Physiotherapy and Research Centre
AHC Complex, Moodubidire, DK
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9789906015 |
| Fax |
|
| Email |
hrkums63@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy
Alvas College of Physiotherapy and Research Centre |
|
|
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 |
| Dr HARIHARASUDHAN RAVICHANDRAN |
Alvas College of Physiotherapy and Research Centre |
Department of Physiotherapy
AHC Complex, Moodubidire, DK
Dakshina Kannada
KARNATAKA |
9789906015
hrkums63@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD OF ALVAS COLLEGE OF PHYSIOTHERAPY AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASYMPTOMATIC HEALTHY INDIVIDUALS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Individuals with asymptomatic lower limb
Normal Body Mass Index
Willingness to participate |
|
| ExclusionCriteria |
| Details |
Presence of neurologic or orthopaedic or any disorder directly or indirectly influencing ankle joint musculoskeletal integrity
Recent fractures or any pathologies or surgeries in lower limb
History of immobilization with or without joint stiffness in lower limb in past 1 year
Congenital or acquired deformities of lower limb |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modified weight bearing lunge test using goniometer |
Baseline and after 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="198"
Sample Size from India="198"
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)
|
02/08/2023 |
| 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)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
The objective of this study is to determine the concurrent validity and test retest reliability of weight bearing lunge test using goniometer in ankle dorsiflexion range of motion. |