| CTRI Number |
CTRI/2025/04/084641 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Talar Mobility, Deep Squat Performance, and Foot and Ankle Function in Individuals with Foot and Ankle Injuries: A Cross-Sectional Study |
|
Scientific Title of Study
|
Correlation Between Talar Mobility, Deep Squat Performance, and Foot and Ankle Function In People with Foot and Ankle Injuries: 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 |
Shristi Tiwari |
| Designation |
PG Student |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
D 110 KMC Falnir PG hostel
D 110 KMC Falnir PG hostel
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
06355783289 |
| Fax |
|
| Email |
shristi.mchpmlr2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijaya Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Department of Physiotherapy, Kasturba Medical College, Mangalore |
| Address |
Department of Physiotherapy, Kasturba Medical College,
Mangalore, Center for Basic Sciences, Bejai, Mangalore-575004
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8148745409 |
| Fax |
|
| Email |
vijayan.pswmy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vijaya Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Department of Physiotherapy, Kasturba Medical College, Mangalore |
| Address |
Department of Physiotherapy, Kasturba Medical College,
Mangalore, Center for Basic Sciences, Bejai, Mangalore-575004
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8148745409 |
| Fax |
|
| Email |
vijayan.pswmy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Kasturba Medical College,
Mangalore, Center for Basic Sciences, Bejai, Mangalore-575004 |
|
|
Primary Sponsor
|
| Name |
Shristi Sanjay Tiwari |
| Address |
Department of Physiotherapy, Kasturba Medical College, Mangalore, Center for Basic Sciences, Bejai, Mangalore, 575004 |
| Type of Sponsor |
Other [self] |
|
|
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 Shristi Tiwari |
KMC Jyothi Hospital, KMC Attavar - Physiotherapy Department, 2nd Floor Hospital |
D 110 KMC Falnir PG hostel
Dakshina Kannada
KARNATAKA |
06355783289
shristi.mchpmlr2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M70-M79||Other soft tissue disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ankle sprain, strain,post fractures with independent ambulation
injury sustained within 1 to 3 months
both male and female participants |
|
| ExclusionCriteria |
| Details |
Conditions affecting hip or knee
Neurologic conditions affecting lower limb function
Ankle surgery
severe osteoarthritis or rheumatoid arthritis
Non ambulaory |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Talar mobility |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ankle range of motion |
baseline |
| deep squat test - overhead, forward |
baseline |
| Foot & ankle ability measure |
baseline |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
22/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/04/2025 |
| 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)
|
Open to Recruitment |
| 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
|
Purpose: To investigate the association between talar hypomobility, deep squat performance, and foot and ankle function in athletes with sports-related foot and ankle injuries.
Rationale: Foot and ankle injuries are prevalent and significantly affect quality of life. Limited ankle dorsiflexion range of motion (DFROM) and talar hypomobility are key contributors to these injuries.
Clinical Relevance: Findings could inform rehabilitation protocols and improve outcomes for athletes with specific biomechanical impairments.
Key Components
1. Aim: To explore correlations between talar mobility, squat performance, and foot and ankle ability in athletes with foot and ankle injuries.
2. Objectives:
Evaluate squat performance using Likert scoring.
Assess foot and ankle ability via FAAM (Foot and Ankle Ability Measure).
Examine associations between talar mobility, squat performance, and FAAM scores.
3. Methodology:
Design: Cross-sectional study.
Participants: Adults aged 18–65 with recent foot and ankle injuries.
Tools:
Goniometer (non-weight-bearing DFROM),
Inclinometer (weight-bearing DFROM),
Talar Swing Test (for talar hypomobility),
Overhead Deep Squat Test (Likert scale evaluation),
FAAM questionnaire (functional assessment).
4. Analysis:
Descriptive statistics for demographics.
Correlation analysis (Spearman’s rank) to assess the relationship between variables.
Findings Anticipated
Correlations between talar mobility, squat depth, and functional outcomes may guide targeted interventions.
Results could contribute to injury prevention strategies and rehabilitation techniques.
Ethical and Procedural Considerations
Study abides by ethical guidelines from Kasturba Medical College, Mangalore, and the Declaration of Helsinki.
Informed consent and participant confidentiality are prioritized.
Clinical Implications
The study may help tailor rehabilitation programs for biomechanical deficits in athletes, optimizing functional recovery and reducing reinjury risks. |