| CTRI Number |
CTRI/2025/08/092255 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| 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
|
Impact of foot and ankle exercises on foot function and balance in plantar fasciitis patients |
|
Scientific Title of Study
|
Effect of short foot exercises and ankle
proprioceptive neuromuscular
facilitation exercises on foot function and dynamic balance 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 |
Harsimran Kaur |
| Designation |
PG Student |
| Affiliation |
College of Physiotherapy, PGIMS, Rohtak |
| Address |
Physiotherapy Department, E Block, College of Physiotherapy, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9812710064 |
| Fax |
|
| Email |
harsimran0073@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Mehra |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy, PGIMS, Rohtak |
| Address |
Physiotherapy Department, Teaching Staff Room, E- Block, College of Physiotherapy, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8814063412 |
| Fax |
|
| Email |
sumanmehra2017@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harsimran Kaur |
| Designation |
PG Student |
| Affiliation |
College of Physiotherapy, PGIMS, Rohtak |
| Address |
Physiotherapy Department, E Block, College of Physiotherapy, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9812710064 |
| Fax |
|
| Email |
harsimran0073@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India, 124001 |
|
|
Primary Sponsor
|
| Name |
College of Physiotherapy PGIMS Rohtak |
| Address |
Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India, 124001 |
| Type of Sponsor |
Government medical college |
|
|
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 Harsimran Kaur |
Outpatient department Orthopedics, Room No 30 and College of physiotherapy |
Pt. B. D. Sharma PGIMS, Rohtak
Rohtak
HARYANA |
9812710064
Harsimran0073@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt. B. D. Sharma PGIMS/UHS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M709||Unspecified soft tissue disorder related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional physiotherapy which include contrast bath, stretching and strengthening exercises |
3 days/week for 4 weeks |
| Intervention |
short foot exercises and ankle proprioceptive neuromuscular facilitation exercises |
3 days/week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Diagnosed cases of plantar fasciitis
2) Gender: Both male and female
3) Age: 40-60 years |
|
| ExclusionCriteria |
| Details |
1) Subjects who have received corticosteroids injection in heel in preceding 3 months
2) Subjects having auto immune or systemic inflammatory disorders
3) Subjects having neurological disorders leading to impaired muscle strength, balance and coordination
4) Subjects having surgical history of plantar fascia, foot and ankle fracture or any other lower extremity injury during the previous 6 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Foot function index(FFI)
Timed up and go test(TUG) test |
day 0, day 14 and day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Numeric pain rating scale(NPRS)
Navicular drop test |
day 0, day 14 and day 28 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/08/2025 |
| 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 Yet Recruiting |
| 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
|
Plantar fasciitis is a common cause of heel pain that affects walking and balance in middle-aged adults. It often leads to reduced foot function and difficulty performing daily activities. This study will evaluate the effect of short foot exercises and ankle proprioceptive neuromuscular facilitation exercises on pain, foot arch, foot function, and dynamic balance in patients with plantar fasciitis. Sixty participants aged between 40 to 60 years will be randomly divided into four groups. Group A will receive conventional physiotherapy treatment. Group B will receive short foot exercises and ankle proprioceptive neuromuscular facilitation along with conventional treatment. Group C will receive short foot exercises with conventional treatment. Group D will receive ankle proprioceptive neuromuscular facilitation with conventional treatment. Outcome measures will include pain intensity using Numeric Pain Rating Scale, foot function using Foot Function Index, arch height using Navicular Drop Test, and balance using Timed Up and Go test. The aim is to identify the most effective intervention strategy that shows significant effect on pain, foot arch, foot function and dynamic balance in plantar fasciitis. |