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CTRI Number  CTRI/2024/03/063669 [Registered on: 06/03/2024] Trial Registered Prospectively
Last Modified On: 05/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Balance problem, presence of fear of fall and foot function in individuals with heel pain 
Scientific Title of Study   Balance impairment, presence of fear of fall and regional functional status in individuals with unilateral 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  PRIYADHARSHINI V 
Designation  MPT STUDENT 
Affiliation  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH 
Address  DEPARTMENT OF PHYSIOTHERAPY SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH NO,1 RAMACHANDRA NAGAR ,PORUR,CHENNAI-116

Chennai
TAMIL NADU
600116
India 
Phone  9600963834  
Fax    
Email  priyavaradh21@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  SUBBIAH K 
Designation  ASSOCIATE PROFESSOR 
Affiliation  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH 
Address  FACULTY OF PHYSIOTHERAPY DEPARTMENT OF PHYSIOTHERAPY SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH NO,1 RAMACHANDRA NAGAR,PORUR, CHENNAI-600116

Chennai
TAMIL NADU
600116
India 
Phone  9443033118  
Fax    
Email  subbiah@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  SUBBIAH K 
Designation  ASSOCIATE PROFESSOR 
Affiliation  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH 
Address  FACULTY OF PHYSIOTHERAPY DEPARTMENT OF PHYSIOTHERAPY SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH NO,1 RAMACHANDRA NAGAE PORUR,CHENNAI-600116


TAMIL NADU
600116
India 
Phone  9443033118  
Fax    
Email  subbiah@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
Department of Physiotherapy- OPD faculty of physiotherapy Sri Ramachandra Institute of Higher Education and Research No,1 Ramachandra Nagar, porur chennai-600116 
 
Primary Sponsor  
Name  Ms V PRIYA DHARSHINI 
Address  Faculty of Physiotherapy SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH NO,1 RAMACHANDRA NAGAR PORUR,CHENNAI-600116 Tamil nadu, INDIA 
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 
Dr PRIYADHARSHINI V   SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH   DEPARTMENT OF PHYSIOTHERAPY- (OUTPATIENT DEPARTMENT) NO 1 SRI RAMACHANDRA NAGAR PORUR, CHENNAI - 116
Chennai
TAMIL NADU 
9600963834

priyavaradh21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE FOR STUDENTS PROJECTS DHR/ICMR REG NO : EC/NEW/INST/2023/TN/0321  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. patients with unilateral plantar fasciitis
2. Age from 25 to 65 years
3. Both male and female 
 
ExclusionCriteria 
Details  1.Neurological problem interfering balance
2.Age more than 65 years
3.Systematic inflammatory disease and auto immune disease
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Balance and postural stability system  At Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1.Foot function index
2.Falls efficacy scale - I
 
At Baseline 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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)   15/03/2024 
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="0"
Months="6"
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  

Plantar fasciitis results from irritation of the plantar fascia originating from the medial calcaneal tubercle of the heel and structures surrounding the fascia. Plantar fasciitis occur in about 10% of the general population, with 83% of these patients being active, working adults between the ages of 20 and 65. Studies suggest that plantar fasciitis increases the risk of falls in the elderly population and was also found to increase the risk of falls and balance disturbances in the population younger than 65 years of age. Thus the purpose for the study is to compare whether balance impairment affects the regional function and increase the fear of fall in individuals with unilateral plantar fasciitis and in age matched healthy individuals. The impaired balance, fear of fall and regional function has to be noted using the objective measures. After receiving written informed consent, participants with unilateral Plantar fasciitis based on the inclusion criteria and age matched healthy subjects are recruited from Sri Ramachandra physiotherapy OPD for the study. A total sample size of 74 will be taken. To determine the balance impairment Balance and postural stability system is used. The regional function is measured using Foot Function Index and the fear of fall is measured using FES - I questionarie.


 
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