| 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
|
|
|
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
|
|
|
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. |