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CTRI Number  CTRI/2023/05/052269 [Registered on: 03/05/2023] Trial Registered Prospectively
Last Modified On: 02/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   The purpose of this study is to compare the effect of foot core exercises and ankle strengthening on pain, range of motion, and dynamic balance in plantar fasciitis individuals. 
Scientific Title of Study   EFFECT OF FOOT CORE EXERCISES VS ANKLE PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION ON PAIN, RANGE OF MOTION, AND DYNAMIC BALANCE IN INDIVIDUALS WITH PLANTAR FASCIITIS: A COMPARATIVE STUDY. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manali A Boob 
Designation  PG Student 
Affiliation  Ravi Nair Physiotherapy College. 
Address  Department of Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institue of Higher Education and Research (Deemed to be University), Sawangi (Meghe)

Wardha
MAHARASHTRA
442001
India 
Phone  7768866097  
Fax    
Email  manaliboob@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pratik Phansopkar  
Designation  Associate Professor and HOD 
Affiliation  Ravi Nair Physiotherapy College. 
Address  Department of Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institue of Higher Education and Research (Deemed to be University), Sawangi (Meghe)

Wardha
MAHARASHTRA
442001
India 
Phone  9890827710  
Fax    
Email  drpratik77@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pratik Phansopkar  
Designation  Associate Professor and HOD 
Affiliation  Ravi Nair Physiotherapy College. 
Address  Department of Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institue of Higher Education and Research (Deemed to be University), Sawangi (Meghe)

Wardha
MAHARASHTRA
442001
India 
Phone  9890827710  
Fax    
Email  drpratik77@gmail.com  
 
Source of Monetary or Material Support  
Ravi Nair Physiotherapy College, Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institue of Higher Education and Research (Deemed to be University), Sawangi (Meghe) Wardha, Maharashtra, India. 
 
Primary Sponsor  
Name  Ravi Nair Physiotherapy College. 
Address  Department of Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institue of Higher Education and Research (Deemed to be University), Sawangi (Meghe) Wardha. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Manali A Boob  Acharya Vinoba Bhave Rural Hospital and Musculoskeletal Physiotherapy OPD of RNPC  Department of Musculoskeletal Physiotherapy, unit 1,Ravi Nair Physiotherapy College, Datta Meghe Institue of Higher Education and Research (Deemed to be University), Sawangi (Meghe)
Wardha
MAHARASHTRA 		 7768866097

manaliboob@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M722||Plantar fascial fibromatosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ankle Proprioceptive Neuromuscular Facilitation (PNF)  Ankle Proprioceptive Neuromuscular Facilitation (PNF) includes slow reversal (SR), and rhythmic stabilization (RS) along with conventional therapy which includes ultrasound, plantar fascia stretching, and Achilles stretching. The PNF protocol last for 30 mins with 10 mins of conventional therapy. The entire protocol lasts for 40 min, 5 days a week, for 6 weeks. 
Comparator Agent  Foot Core Exercises  Foot core exercises which includes heel raises, towel curls, foot doming, toe spread, balance board, and foot relaxation exercises by stepping on a tennis ball with progressive intensity along with conventional therapy which includes ultrasound, plantar fascia stretching, and Achilles stretching. The Foot core exercises last for 30 mins with 10 mins of conventional therapy. The entire protocol lasts for 40 min, 5 days a week, for 6 weeks 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) A progressive onset of heel pain lasting three months or more, localized to the medial calcaneal tubercle.
2) Sharp and worsen pain with the first few steps out of bed in morning.
3) Positive windlass test. 
 
ExclusionCriteria 
Details  1) Patients with type 1 or 2 Diabetes Mellitus, systemic inflammatory arthritis, cancer, active tuberculosis.
2) Arthrosis of the ankle, knee, and hip.
3) Pregnant women.
4) Patients with numbness or tingling with or without provocation in the lower extremity, undiagnosed pain.
5) Patients currently receiving treatment and using steroids within the last six months for the plantar fasciitis. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Foot Function Index (FFI)
2) The Modified Star Excursion Balance Test (mSEBT)
 		 Outcomw will be assessed at baseline and after 6 weeks.
 
 
Secondary Outcome  
Outcome  TimePoints 
1) The Visual Analogue Scale (VAS)
2) Weight Bearing Lunge Test (WBLT) 		 Outcomw will be assessed at baseline and after 6 weeks. 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   15/05/2023 
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   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 15-05-2023 and end date provided 15-05-3073?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The present study intends to compare the effect of foot core exercises and ankle proprioceptive neuromuscular facilitation on pain, range of motion and dynamic balance in patients with plantar fasciitis. 
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