| CTRI Number |
CTRI/2025/03/083177 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
To compare the effect of lower limb functional chain exercises with traditional exercises along with elastic tape for pain and foot function in people with heel pain |
|
Scientific Title of Study
|
A study on assessing the lower limb kinetic chain activation exercises with kinesiotape versus conventional exercises with kinesiotape on pain and foot function in subjects with plantar fasciitis - a comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
POORNASHREE G |
| Designation |
Post graduate student |
| Affiliation |
Dayananda sagar university |
| Address |
Dayananda Sagar University School of Health Sciences- department of physiotherapy Devarakaggalahalli, Harohalli Kanakapura Road, Dt, Ramanagara
Bangalore Rural KARNATAKA 562112 India |
| Phone |
07259216185 |
| Fax |
|
| Email |
poornagowda0130@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr VINOD KUMAR K C |
| Designation |
Associate professor |
| Affiliation |
Dayananda sagar university |
| Address |
Dayananda Sagar University School of Health Sciences- department of physiotherapy Devarakaggalahalli, Harohalli Kanakapura Road, Dt, Ramanagara Karnataka 562112 Bangalore Rural KARNATAKA 562112 India |
| Phone |
9036200878 |
| Fax |
|
| Email |
vinod-mpt@dsu.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr VINOD KUMAR K C |
| Designation |
Associate professor |
| Affiliation |
Dayananda sagar university |
| Address |
Dayananda Sagar University School of Health Sciences- department of physiotherapy Devarakaggalahalli, Harohalli Kanakapura Road, Dt, Ramanagara Karnataka 562112
KARNATAKA 562112 India |
| Phone |
9036200878 |
| Fax |
|
| Email |
vinod-mpt@dsu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dayananda sagar college of physiotherapy |
|
|
Primary Sponsor
|
| Name |
poornashree g |
| Address |
Dayananda Sagar University School of Health Sciences- department of physiotherapy Devarakaggalahalli, Harohalli Kanakapura Road, Dt, Ramanagara
Karnataka 562112
Bangalore Rural
India |
| Type of Sponsor |
Other [poornashree g (self)] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| poornashree g |
Dayananda Sagar University School of Health Sciences- department of physiotherapy Devarakaggalahalli, Harohalli Kanakapura Road, Dt, Ramanagara
Karnataka 562112
Bangalore Rural
India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr VINOD KUMAR K C |
Dayananda sagar university |
HS building MSK department Dayananda Sagar college of Physiotherapy Devarakaggalahalli, Harohalli Kanakapura Road, Dt, Ramanagara
Karnataka 562112 Bangalore Rural KARNATAKA |
09036200878
vinod-mpt@dsu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dayananda Sagar university-institutional ethics committe-institutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M722||Plantar fascial fibromatosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional exercises with kinesiotape |
conventional exercises for foot and ankle which includes stretching and strengthening exercises
KT is applied to the plantar fascia.It is applied twice a week,for 6 weeks.The taping is marked on the Achilles Tendon.During the taping,patient should be in prone ;position with the knee joints at of flexion and ankle joint at neutral position.The tape is cut longitudinally into four slices of equal width.It is applied on the forefoot by stretching it 25%,Finally,the KT space correction method is then applied. |
| Intervention |
lower limb kinetic chain activation exercises with kinesiotape |
lower limb kinetic chain activation exercises involving hip knee and ankle joints for
KT is applied to the plantar fascia.It is applied twice a week,for 6 weeks.The taping is marked on the Achilles Tendon.During the taping,patient should be in prone ;position with the knee joints at of flexion and ankle joint at neutral position.The tape is cut longitudinally into four slices of equal width.It is applied on the forefoot by stretching it 25%,Finally,the KT space correction method is then applied. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Duration of symptoms lasting for 3 months or more with pain intensity of 3 or higher on NPRS during activity
2)Pain with first steps up on walking after waking up or during walking after rest and decreased pain at the onset of activity but worsening pain as the activity continues
3)Pain with tenderness on palpation at the medial tubercle of calcaneus
4)Positive Windlass test
5)Willing to sign the informed consent form
|
|
| ExclusionCriteria |
| Details |
1)History of any lower limb injuries
2)Use of any assistive device for ambulation
3)Any medical or surgical treatment pre or during the study period
4)Any history of rheumatoid arthritis, metabolic or neurological abnormalities
5)Any history of corticosteroid injections
6)Pregnancy
7)Kinesiotape sensitivity
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
pain intensity-pressure algometer
foot function index(FFI) |
pre(0weeks)
post(6 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
range of motion(ROM)
foot posture index(FPI) |
0 weeks and 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/04/2025 |
| 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="0" Months="6" 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
|
A Study on Assessing the Effect of Lower Limb Kinetic Chain Activation Exercises with Kinesiotape Versus Conventional Exercises with Kinesiotape on Pain and Foot Function in Subjects with Plantar Fasciitis" aims to compare the effectiveness of two exercise approaches in managing plantar fasciitis. This condition, characterized by heel pain due to biomechanical issues like a tight Achilles tendon, affects about 10% of the population. Conventional treatments include anti-inflammatory drugs, stretching, and kinesiotaping, but the potential benefits of integrating kinetic chain exercises have not been fully explored. The study compares two groups: one performing lower limb kinetic chain activation exercises with kinesiotape and the other doing conventional exercises with kinesiotape. It evaluates pain and foot function using the Range of Motion (ROM) of the ankle,Pressure algometer, Foot Posture Index (FPI), and Foot Function Index (FFI). The null hypothesis states that there will be no significant difference between the two exercise approaches, while the alternate hypothesis suggests a significant difference in pain relief and foot function. Conducted over six months, the study seeks to provide insights that could optimize plantar fasciitis treatment strategies, improving patient outcomes. Ethical clearance is obtained from Dayananda Sagar University, Bangalore. |