| CTRI Number |
CTRI/2026/01/101513 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of abdominal exercises on pain foot position balance and quality of life among flatfoot individual with plantar fasciitis |
|
Scientific Title of Study
|
Effect of core stabilization exercises on pain foot posture balance and quality of life among pes planus individual
with plantar fasciitis a randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anumol C |
| Designation |
Assistant professor |
| Affiliation |
Little flower institute of medical sciences and research |
| Address |
Little flower institute of medical sciences and research
Department of physiotherapy
7th floor
St alphonsa block
LF hospital campus
Angamaly
Ernakulam
KERALA
683572
India |
| Phone |
9495234411 |
| Fax |
|
| Email |
anusanthosh4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamaraj B |
| Designation |
Principal |
| Affiliation |
|
| Address |
AKG cooperative institute of health sciences
Department of physiotherapy
Mavilayi P O
Kannur
Kannur
KERALA
670622
India |
| Phone |
9744903443 |
| Fax |
|
| Email |
kamrajmpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anumol C |
| Designation |
Assistant professor |
| Affiliation |
Little flower institute of medical sciences and research |
| Address |
Little flower institute of medical sciences and research
Department of physiotherapy
7th floor
St Alphonsa block
LF hospital campus angamaly
Ernakulam
KERALA
683572
India |
| Phone |
9495234411 |
| Fax |
|
| Email |
anusanthosh4@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Little flower institute of medical sciences and research |
| Address |
Little flower institute of medical sciences and research angamaly |
| 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 |
| Reeba roy |
Little flower hospital and research centre |
Department of physiotherapy
Little flower hospital and research centre
Angamaly
Ernakulam
KERALA |
9446128509
reebanjv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee little flower hospital and research centre |
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 |
Conventional exercises |
Conventional exercises including stretching and strengthening exercises for eight weeks |
| Intervention |
Core stabilization exercises |
Core stabilization exercises combined with conventional exercises given for eight weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed case of Plantar fasciitis with duration greater than 3 months
Individuals with Pes planus measured with Navicular drop test Navicular drop of 10 mm or more
Pain pressure threshold of 2 kg and below assessed using algometer
Transverse abdominis activation score less than 2 mmHg and greater than10 mm Hg
|
|
| ExclusionCriteria |
| Details |
Neurological conditions affecting balance
Recent lower limb and spinal fracture
Recent surgeries and implant in lower extremity and spine
Any degenerative and inflammatory diseases of lower extremity and spine
Peripheral vascular diseases
Malignancy
Foot deformities other than pesplanus
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Static balance
Dynamic blance |
Baseline and after eight weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain
Foot posture
Quality of life |
Baseline & after eight weeks |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
03/02/2026 |
| 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="2"
Months="2"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Pes planus individual are prone to injuries because of poor foot posture reduced balance and reduced proximal muscle strength Core stabilization exercises combine with conventional exercises will be given to experimental group for eight weeks Control group will receive only conventional exercise for eight weeks |