| CTRI Number |
CTRI/2023/08/056445 [Registered on: 11/08/2023] Trial Registered Prospectively |
| Last Modified On: |
13/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association of Core Muscle Strength and Endurance with Chronic Ankle Instability |
|
Scientific Title of Study
|
Association of Core Muscle Strength and Endurance with Chronic Ankle Instability - a cross sectional 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 |
Srijanya Rajesh |
| Designation |
PG Student |
| Affiliation |
Kasturba Medical College, Mangalore, MAHE. |
| Address |
Department of Physiotherapy, Second Floor, Room No. 3, Kasturba Medical College Hospital, Attavar, Mangalore, KARNATAKA
575004 India
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9080958609 |
| Fax |
|
| Email |
janyarajesh99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Ashish John Prabhakar |
| Designation |
Assistant Professor- Selection grade |
| Affiliation |
Kasturba Medical College, Mangalore, MAHE. |
| Address |
Department of Physiotherapy, Fifth floor, KMC Hospital, Umbedkar Circle, Mangalore, KARNATAKA, India
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8123223092 |
| Fax |
|
| Email |
ashish.john@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mr Ashish John Prabhakar |
| Designation |
Assistant Professor- Selection grade |
| Affiliation |
Kasturba Medical College, Mangalore, MAHE. |
| Address |
Department of Physiotherapy, Fifth floor, KMC Hospital, Umbedkar Circle, Mangalore, KARNATAKA, India
KARNATAKA
575002
India |
| Phone |
8123223092 |
| Fax |
|
| Email |
ashish.john@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Mangalore. |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy KMC Hospital |
| Address |
Department of Physiotherapy, Fifth floor, KMC Hospital, Umbedkar Circle, Mangalore, KARNATAKA, India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Srijanya Rajesh |
Kasturba Medical College Hospital |
Department of Physiotherapy, Second Floor, Room No. 3, Kasturba Medical College Hospital, Attavar, Mangalore, KARNATAKA 575004 India
Dakshina Kannada
KARNATAKA |
9080958609
janyarajesh99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, KMC, Mangalore. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M253||Other instability of joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
History of at least one acute ankle sprain that resulted in inflammation and impaired physical activity.
The most recent sprain should be ≥3 months.
≥2 episodes of “giving way†and/or recurrent ankle sprain and/or
feelings of instability at the ankle
A score of ≤24 on the Cumberland Ankle Instability Tool.
Age 18-45 years
|
|
| ExclusionCriteria |
| Details |
A history of previous surgeries of lower extremity musculoskeletal structures, including bone, ligaments, and/or nerve injury
Any acute injury to musculoskeletal structures of the lower limb, either sprain, strain, or fracture in the last 3 months
Recent open abdominal surgery/hernia repair in the past 8 weeks
Patients with HTN, cardiac issues
Patients with hernia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cumberland Ankle Instability Tool, McGill’s torso muscular endurance test battery |
The above mentioned outcome measures will be assessed only at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
24/08/2023 |
| 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="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
|
This
study aims to explore the association of core muscle strength and endurance
with chronic ankle instability. Participants with ankle instability will be assessed for core muscular strength and endurance and compared with participants who do not have ankle instability. This study will further check the association between chronic
ankle instability and core muscle strength as well as check for association between chronic ankle instability and core endurance.
|