| CTRI Number |
CTRI/2022/09/045717 [Registered on: 20/09/2022] Trial Registered Prospectively |
| Last Modified On: |
09/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Kinetic Chain Activation Technique on foot pressure, pain and its effects on daily activities - A Randomized Controlled Trial |
|
Scientific Title of Study
|
Kinetic chain activation technique on plantar pressure;pain threshold and activity limitation in individuals with Plantar fasciitis.A Randomised controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chandana patil |
| Designation |
Post graduate student |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
Department of orthopedic physiotherapy, KAHER institute of physiotherapy, JNMC campus nehru nagar
Department of orthopedic physiotherapy, KAHER institute of physiotherapy, JNMC campus nehru nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
8197807656 |
| Fax |
|
| Email |
chandupatil.csp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aarti Welling |
| Designation |
Assistant professor |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
Department of orthopedic physiotherapy, KAHER institute of physiotherapy, JNMC campus nehru nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
9448814569 |
| Fax |
|
| Email |
aartiwelling@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Designation |
Post graduate student |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
Department of orthopedic physiotherapy, KAHER institute of physiotherapy, JNMC campus nehru nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
8197807656 |
| Fax |
|
| Email |
chandupatil.csp@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER institute of physiotherapy |
|
|
Primary Sponsor
|
| Name |
KAHER institute of physiotherapy |
| Address |
KAHER institute of physiotherapy JNMC campus nehru nagar belagavi |
| 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 |
| Chandana patil |
KLE hospital |
advance physiotherapy center OPD no 18
Belgaum
KARNATAKA |
8197807656
chandupatil.csp@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER institute of physiotherapy research and ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
plantar fasciitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group- ultrasound and exercises |
5 times in a week for 2 weeks |
| Intervention |
kinetic chain activation technique |
5 times in a week for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All genders aged between 19 to 65 years diagnosed with plantar fasciitis.
Individuals who have positive windlass test
Individuals who present with unilateral or bilateral pain during the initial steps in the morning
Individuals whose VAS score is ≥ 3
|
|
| ExclusionCriteria |
| Details |
Lower limb fracture in last 6 months
Corticosteroid injection in the heel in past 3 months
Plantar fibromatosis (or) ledderhose disease
Sprain and strains in ankle-foot region
Foot surgeries in last 6 months
Impaired sensation in lower extremities
Ankylosis or arthritis of ankle
Calcaneal spur
Congenital foot deformities
Lower limb deformities
OA with varus or valgus deformities
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pressure algometer
Foot function index
Chippaux – smirak index with Harris mat foot imprinter |
at base line i.e is on day 0 and 14 day after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/09/2022 |
| Date of Study Completion (India) |
10/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Participant selection will be done as per the Inclusion and exclusion criteria. The purpose and procedure of the study will be explained to the participants. All the covid-19 precautionary measures according to ICMR will be taken. A brief demographic data and baseline outcome measures will be obtained from the participants. Participants will be equally divided into two groups using chit method Group therapy sessions will be carried out in the respective colleges of KAHER institute. Group A will be given Kinetic chain activation technique and Group B will be given conventional treatment |