| CTRI Number |
CTRI/2024/11/076626 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring the link between spiral line activation and ankle stability in college students |
|
Scientific Title of Study
|
Co-relation of spiral line Activation and Ankle Stability in Young Collegiate Students: An Analytical 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 |
Dr. Vasudha Siddappa |
| Designation |
Assistant Professor of Orthopaedic Manual Therapy (OMT) |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Advanced Physiotherapy Centre, OPD No. 39, Department of Orthopaedic Manual Therapy, Room No. 13, Sagar Floor KLEs Dr. Prabhakar Kore Hospital and MRC, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590 010
India |
| Phone |
8147611796 |
| Fax |
|
| Email |
vasudhasiddappa@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vasudha Siddappa |
| Designation |
Assistant Professor of Department of Orthopaedic Manual Therapy |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Advanced Physiotherapy Centre, OPD No. 39, Department of Orthopaedic Manual Therapy, Room No. 13, Sagar Floor KLEs Dr.Prabhakar Kore Hospital and MRC, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8147611796 |
| Fax |
|
| Email |
vasudhasiddappa@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Smruti Mane |
| Designation |
Physiotherapy Intern |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Advanced Physiotherapy Centre, OPD No. 39, Department of Orthopaedic Manual Therapy, Room No. 13, Sagar Floor KLEs Dr.Prabhakar Kore Hospital and MRC, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8147611796 |
| Fax |
|
| Email |
smrutimane2813@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and
Research Institute of Physiotherapy, Medical College Campus J.N, Nehru Nagar, Belagavi, Karnataka, India 590010
|
|
|
Primary Sponsor
|
| Name |
KAHER Institute of Physiotherapy Self Sponsored |
| Address |
KAHER Institute of Physiotherapy, Orthopaedic Manual Therapy (OMT) Physiotherapy OPD no.13 Medical College Campus, J.N, Nehru Nagar, Belagavi, Karnataka 590010 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vasudha Siddappa |
KAHER Institute OF Physiotherapy |
KAHER Institute of Physiotherapy, Department of Orthopaedic Manual Therapy Physiotherapy OPD No. 39, Medical College Campus, J.N, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA |
8147611796
vasudhasiddappa@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Institute Of Physiotherapy Research & Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
1. All genders of students between 18-26 years of age
2. Constituent units of Health Science Universities in Belagavi city
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
1. Constituent units of Health Science Universities in Belagavi city
2. Participants willing to participate in the study
3. Participants present on the day of the assessment
|
|
| ExclusionCriteria |
| Details |
1. Participants giving History of trauma, injury, or surgery in the past at the spine, hip, knees, and ankle (for the past 6 Months)
2. Participants with any structural deformities in the foot.
3. Participants diagnosed with any Neurological conditions.
4. BMI between 25 kg/m2 to 29.9 kg/m2
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Foot and Ankle Disability Index (FADI) |
A Self-reported questionnaire used to assess functional limitations related to foot and ankle conditions.
The FADI has 26 items. Each item is scored from 0 (unable to do) to 4 (no difficulty at all). The 4 pain items of the FADI are scored 0 (unbearable) to 4 (none). The FADI has a total point value of 104 points |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Cumberland Ankle Instability Tool (CAIT |
A Validated questionnaire designed to assess ankle instability, particularly in individuals who have experienced recurrent ankle sprains or other types of ankle instability. The CAIT is a 9-item questionnaire that assesses pain, ankle instability, and recovery after sprains for both ankles.
A Total score for each foot ranges from 0 to 30, with 0 being the worst possible score and 30 being the best |
|
|
Target Sample Size
|
Total Sample Size="502"
Sample Size from India="502"
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)
|
20/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/11/2024 |
| 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
|
Aim of study:To determine the correlation between spiral line and ankle
stability among young-collegiate students. OBJECTIVES: - To determine the spiral line muscles
strength using the push-pull dynamometer among
young collegiate students. •
To
determine the ankle stability by Foot and ankle disability index and Cumberland
ankle
instability tool among
young collegiate students. • INCLUSION CRITERIA: 1. All genders of students between
18-26 years of age 2. Constituent units of Health Science
Universities in Belagavi city 3. Participants willing to participate
in the study 4. Participants present on the day of
assessment • • EXCLUSION CRITERIA:
1. Participants giving History of
trauma, injury, or surgery in the past at the spine, hip, knees and ankle (for
the past 6 Months)
2. Participants with any structural
deformities in the foot.
3. Participants diagnosed of any
Neurological conditions. 4. BMI above 25-29.9kg/m2
• Participants
will be assessed for all the muscles of the spiral chain based on Pushpull Hand
Held Dynamometer
• A
self reported questionnaire of Cumberland ankle instability tool and Foot and
ankle disability index will be given to the participants for assessing of their
ankle stability. Expanding research to include the Spiral Line and its relation to ankle stability may explore potential rehabilitation strategies that address global body mechanics, and might offer a more comprehensive approach to treating chronic ankle instability. |