| CTRI Number |
CTRI/2024/05/067920 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
20/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Checking Balance during movement: Reliability and Validity of the Four Square Step Test in Young Adults with Chronic Ankle Instability |
|
Scientific Title of Study
|
Reliability and validity of the four square step test to assess dynamic balance in young adults with chronic ankle instability |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raval Bhavi Mukund |
| Designation |
Post graduate student |
| Affiliation |
Nitte Institute of Physiotherapy, NITTE (Deemed to be University) |
| Address |
Department of Physiotherapy
Room No 20, Second Base Division, Nitte Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9769278882 |
| Fax |
|
| Email |
drbhaviraval@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saumya Srivastava |
| Designation |
Associate Professor |
| Affiliation |
Nitte Institute of Physiotherapy, NITTE (Deemed to be University) |
| Address |
Department of Physiotherapy
Room No 20, Second Base Division, Nitte Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9740244077 |
| Fax |
|
| Email |
saumyasri2000@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Raval Bhavi Mukund |
| Designation |
Post graduate student |
| Affiliation |
Nitte Institute of Physiotherapy, NITTE (Deemed to be University) |
| Address |
Department of Physiotherapy
Room No 20, Second Base Division, Nitte Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9769278882 |
| Fax |
|
| Email |
drbhaviraval@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nitte Institute of Physiotherapy, NITTE (Deemed to be University) will provide basic infrastructure facilities, no other monitory support is required |
|
|
Primary Sponsor
|
| Name |
Nitte Institute of Physiotherapy, NITTE (Deemed to be University) |
| Address |
Department of Physiotherapy, Room No-20, Second Base Division, Nitte Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka, 575018, India |
| Type of Sponsor |
Other [Constituent college of Nitte Institute of Physiotherapy, NITTE (Deemed to be University)] |
|
|
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 Saumya Srivastava |
Justice K.S Hegde Charitable Hospital |
Department of Physiotherapy
Room No 20, Second Base Division, Nitte Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India
Dakshina Kannada
KARNATAKA |
9740244077
saumyasri2000@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Nitte Institue of Physiotherapy |
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.H/o unilateral lateral ankle sprain (1-7 years)
2.Individual self-complaining of the ankle giving away, and getting a score of less than or equal to 25 in CAIT
3.Positive Anterior Drawer test for the ankle
4.NPRS (0-3) on activity and swelling around the ankle joint (optional)
5.Individuals literate in the English Language |
|
| ExclusionCriteria |
| Details |
1. Lower extremity surgery, fractures, or any acute pain
2. Acute Ankle sprain
3. Ankle fractures, any other ankle injuries
4. NPRS - more than 3
5. Neurological conditions
6. Resting pain at the ankle joint
7. Individuals who are not literate in English language |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Four Square Step Test
2. Y Balance Test |
1. Four Square Step Test- will be done 2 times to check reliability
2. Y Balance Test- will be done 1 time to check validity |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2024 |
| Date of Study Completion (India) |
25/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
There is currently a dearth of literature regarding the application of the Four Square Step Test specifically to individuals with chronic ankle instability (CAI). While the test has been used in various populations, its reliability and validation in the context of Chronic ankle instability is not done. As the prevalence of Chronic ankle instability is so high, the impact on an individual’s daily life is excessive. The Four Square Step Test has the potential to serve as a practical and accessible tool in clinical setups as it requires minimal space and time, making it a cost-effective option for assessing dynamic balance in individuals with chronic ankle instability. Its simplicity could facilitate widespread adoption in rehabilitation and physical therapy settings. As Chronic ankle instability is a common issue, and there is a pressing need for reliable and validated assessment tools to understand and address the unique challenges faced by this population, this study deals with the Reliability and validity of the Four Square Step Test in Chronic Ankle Instability. |