| CTRI Number |
CTRI/2024/11/077465 [Registered on: 28/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Heel pain and its relationship with balance |
|
Scientific Title of Study
|
Relationship of plantar heel pain with balance and plantar pressure in patients
with plantar fasciitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaishnavi Lal Balani |
| Designation |
Post Graduate student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Upper Basement, Department of Physiotherapy, Manipal Hospital, No 98, Rustam Bagh, Old Airport Road, Bangalore, Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
8884756588 |
| Fax |
|
| Email |
vaishnavi1.mhsblr2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karvannan H |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Upper Basement, Department of Physiotherapy, Manipal Hospital, No 98, Rustam Bagh, Old Airport Road, Bangalore, Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
9986565966 |
| Fax |
|
| Email |
karvannan.h@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karvannan H |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Upper Basement, Department of Physiotherapy, Manipal Hospital, No 98, Rustam Bagh, Old Airport Road, Bangalore, Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
9986565966 |
| Fax |
|
| Email |
karvannan.h@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Manipal Hospital No 98, HAL, Old Airport Road, Bangalore KARNATAKA 560017 India Bangalore KARNATAKA 560017 India |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal Hospital No 98, HAL, Old Airport Road, Bangalore KARNATAKA 560017 India Bangalore KARNATAKA 560017 India |
| 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 Karvannan H |
Manipal Hospital |
Upper Basement, Department of Physiotherapy, Manipal Hospital, No 98,Rustam Bagh, Old Airport Road, Bangalore, Karnataka
Bangalore
KARNATAKA |
9986565966
karvannan.h@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Manipal hospitals, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals diagnosed with plantar fasciitis with symptoms that persist more than 3 months |
|
| ExclusionCriteria |
| Details |
Individuals diagnosed with plantar fasciitis whose NPRS is above 7
Individuals with calcaneal spur
Individuals with fat pad atrophy
Individuals with stress fractures
Individuals with nerve entrapments like tarsal tunnel syndrome |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Balance using Biodex Balance System |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| plantar pressure using force plate |
At baseline |
| pain and disability using force plate |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="61" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2024 |
| Date of Study Completion (India) |
28/04/2025 |
| Date of First Enrollment (Global) |
15/12/2024 |
| Date of Study Completion (Global) |
28/04/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
plantar heel pain is a common clinical feature in patients with plantar fasciitis. Literature suggest that plantar fasciitis affects balance and plantar pressure. Maintaining body equilibrium involves keeping the feet in contact with the ground and modifying foot movement to maintain balance when posture changes are necessary. It is common known that task difficulty influences how body weight and distribution affects postural control. Since the contact area shifts along with the change in the plantar pressure to maintain postural balance, we can expect that standing in bipodal or unipodal conditions will have a significant impact on it. |