| CTRI Number |
CTRI/2024/07/070868 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect Of Calf Size On Ankle Stability In People With Plantar Fasciitis: A Cross-Sectional Study |
|
Scientific Title of Study
|
Effect Of Calf Girth On Dynamic Ankle Stability In Individuals With Plantar Fasciitis: 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 |
Fernandes Pearl Joanita |
| Designation |
1st Year MPT |
| Affiliation |
Father Muller College Of Physiotherapy |
| Address |
Father Muller College Of Physiotherapy
Department Of Physiotherapy
Basement floor Room no 10
Father Muller Road, Kankanady Mangalore Dakshina Kannada
Karnataka
-
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9158613161 |
| Fax |
- |
| Email |
pearl.joanita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P Chaitra Bhat |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller College Of Physiotherapy |
| Address |
Father Muller College Of Physiotherapy
Department Of Physiotherapy
basement Floor Room no 10
Father Muller Road, Kankanady Mangalore Dakshina Kannada
Karnataka
-
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8904760245 |
| Fax |
- |
| Email |
chaitraphysio07@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Fernandes Pearl Joanita |
| Designation |
1st Year MPT |
| Affiliation |
Father Muller College Of Physiotherapy |
| Address |
Father Muller College Of Physiotherapy
Department Of Physiotherapy
Basement floor Room no 10
Father Muller Road, Kankanady Mangalore Dakshina Kannada
Karnataka
-
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9158613161 |
| Fax |
- |
| Email |
pearl.joanita@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller College Of Physiotherapy
Department Of Physiotherapy
Basement floor Room no 10
Father Muller Road, Kankanady |
|
|
Primary Sponsor
|
| Name |
Fernandes Pearl Joanita |
| Address |
Father Muller College Of Physiotherapy
Department Of Physiotherapy
Basement floor Room no 10
Father Muller Road, Kankanady |
| 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 |
| Fernandes Pearl Joanita |
Father Muller College of Physiotherapy |
Father Muller College Of Physiotherapy
Department Of Physiotherapy
Basement floor Room no 10
Father Muller Road, Kankanady
Dakshina Kannada 575002
Dakshina Kannada
KARNATAKA |
9158613161
-
pearl.joanita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M722||Plantar fascial fibromatosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
- |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Individuals Clinically diagnosed with acute, sub-acute or chronic unilateral plantar fasciitis with pain symptoms
Normal BMI (18.5 to 24.9 kg/m2) and Overweight category (25 to 29.9 kg/m2)
All genders
Age – 18 years to 65 years
|
|
| ExclusionCriteria |
| Details |
Any existing lower extremity musculoskeletal, cardio vascular and neurological problems affecting ankle stability.
Recently done surgeries for the spine and lower limb (last 6 months)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Calf Girth Using Corrected Calf Girth Formula
|
At Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dynamic Ankle Stability Using Star Excursion Balance Test |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
24/07/2024 |
| 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="1"
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
|
The purpose of this study is to check the effect of calf
girth on dynamic ankle stability in individuals with plantar fasciitis.
Clinically Diagnosed patient
of plantar fasciitis visiting the out-patient department who fall under the
inclusion criteria will be recruited for the study.
Calf girth will be measured
using the corrected calf girth formula. Dynamic ankle stability will be
assessed using the star excursion balance test.
The relationship between the two variables will be estimated
using statistical analysis. |