| CTRI Number |
CTRI/2025/11/096881 [Registered on: 04/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
combined kinetic chain exercise (CKCP) program on OA patients |
|
Scientific Title of Study
|
Effectiveness of combined kinetic chain exercise program (CKCP) on foot posture, dynamic balance and walking speed in individuals with knee osteoarthritis: A Randomized Controlled Trails |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kajal Mahajan |
| Designation |
UG Student |
| Affiliation |
Pravara Institute of Medical Sciences Loni |
| Address |
Sports Physiotherapy Department Dr APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences Loni
Ahmadnagar
MAHARASHTRA
413736
India
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9405758080 |
| Fax |
|
| Email |
kajalmahajan2003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Borkar |
| Designation |
Professor and HOD |
| Affiliation |
Pravara Institute of Medical Sciences Loni |
| Address |
Sports Physiotherapy Department,Dr APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences Lon
Rahata Dist Ahmadnagar Maharashtra
413736
India
Dr APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences Loni Tal Rahata Dist Ahmadnagar Maharashtra Ahmadnagar Maharashtra 413736 India
Ahmadnagar
MAHARASHTRA
413736
India
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9168572881 |
| Fax |
|
| Email |
pnb2609@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Borkar |
| Designation |
Professor and HOD |
| Affiliation |
Pravara Institute of Medical Sciences Loni |
| Address |
Sports Physiotherapy Department,Dr APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences Lon
Rahata Dist Ahmadnagar Maharashtra
413736
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9168572881 |
| Fax |
|
| Email |
pnb2609@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY, Pravara Institude of Medical Sciences Loni Ahmednagar Maharastra 413736 |
|
|
Primary Sponsor
|
| Name |
DR. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY |
| Address |
Sports Physiotherapy Department,Dr. APJ Abdul Kalam College of Physiotherapy,
Pravara Institute of Medical Sciences,Loni,Ahmednagar 413736,Maharashtra,India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Kajal Mahajan |
Dr. APJ Abdul Kalam College of Physiotherapy |
Room no 405,Sports Physiotherapy Department,Dr APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences Loni, Pin 413736 Ahmadnagar Maharashtra
Ahmadnagar
MAHARASHTRA |
9405758080
kajalmahajan2003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M17||Osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
Weeks 1–3
Static hamstring stretch, static quadriceps exercise, straight leg raise in supine lying, straight leg raise in side lying, sitting dynamic quadriceps exercise, wall squat.
Weeks 4–6
Same exercises performed with increased intensity. |
| Intervention |
Intervention group |
Weeks 1–3:
Abdominal isometrics, pelvic bridge, straight leg raise in supine, multi-angle static exercise (30°, 60°, 90°, 120°), wall squat, calf stretch, wring towel with feet, plantar arch raise with forward inclination.
Weeks 4–6:
Same exercises performed with increased intensity. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
45-65 years of age
Diagnosed case of Knee OA Grade 1 & 2 Kellgren and Lawrence grading scale
VAS score ranging between 3 to 6 points
Non operative OA patients
|
|
| ExclusionCriteria |
| Details |
Body Mass Index greater than 35 km per m2
Neurological disease
History of Physical therapy treatment or lower limb strength training in last 3 months
No willing to participate
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Foot posture index (FPI)
Time up & go test
Gait speed test
|
Week 0 and Week 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
15/11/2025 |
| 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
|
| AIMS OF THE STUDY: To find the effectiveness of combined kinetic chain exercise program (CKCP) on Foot posture, dynamic balance & walking speed in individuals with knee osteoarthritis OBJECTIVE OF THE STUDY: - 1. To find the effect of combined kinetic chain exercise program in foot posture using foot posture index (FPI) on the individuals with knee Osteoarthritis 2. To find the effect of combined kinetic chain exercise program in dynamic balance using Time up & go test on the individuals with knee Osteoarthritis 3. To find the effect of combined kinetic chain exercise program in Walking speed using Gait speed test on the individuals with knee Osteoarthritis PROCEDURE
| Then Participants will be randomly allocated 2 groups that is the experimental group and control group. Group A is control group will be given conventional exercise (Hip exercise & Knee exercise) and Group B is experimental group will be given Combined kinetic chain exercise program (Hip exercise, Core exercise, Knee exercise & Foot-Ankle exercise). Exercise given for period of six week. The participants will be given exercise regimen and administered to perform one session per day for 4 days a week. All the instructions will be given verbally, provided demonstration to the participants. Statistical analysis will be done and the results with the conclusion will be mentioned. | | |