| CTRI Number |
CTRI/2025/08/093317 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Kinesio Taping with Neuromuscular Control Exercises in Knee Osteoarthritis |
|
Scientific Title of Study
|
Effectiveness of Kinesio Taping Combined with Neuromuscular Control Exercises
on Pain and Function in Knee Osteoarthritis: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Md Zahid Hasan |
| Designation |
Clinical Physiotherapist |
| Affiliation |
Centre for the Rehabilitation of the Paralysed (CRP) |
| Address |
Centre for the Rehabilitation of the Paralysed (CRP), Dhaka, Bangladesh Dhaka, Bangladesh
1343 Other |
| Phone |
01877790366 |
| Fax |
|
| Email |
zahidhasanrony6666@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Kazi Md Azman Hossain |
| Designation |
Intern Physiotherapist |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh Jashore-7408, Bangladesh
7408 Other |
| Phone |
01660140833 |
| Fax |
|
| Email |
azmanhossain51@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Kazi Md Azman Hossain |
| Designation |
Intern Physiotherapist |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh Jashore-7408, Bangladesh
7408 Other |
| Phone |
01660140833 |
| Fax |
|
| Email |
azmanhossain51@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy
Centre for the Rehabilitation of the Paralysed (CRP), Dhaka, Bangladesh
|
|
|
Primary Sponsor
|
| Name |
Md. Zahid Hasan |
| Address |
Department of Physiotherapy
Centre for the Rehabilitation of the Paralysed (CRP), Dhaka, Bangladesh |
| Type of Sponsor |
Other [self-funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kazi Md Azman Hossain |
Centre for the Rehabilitation of the Paralysed (CRP) |
Room No: 204, MS-2, Physiotherapy Department, Centre for the Rehabilitation of the Paralysed (CRP), Dhaka, Bangladesh
|
01660140833
azmanhossain51@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board (IRB) of Institute of Physiotherapy Rehabilitation and Research (the academic institute of BPA) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group: Neuromuscular control exercise |
The participants will begin with a 10-minute warm-up that includes ergometer cycling, treadmill, or stepper. The neuromuscular exercises will include quadriceps and hamstrings strengthening, lunging, pelvic tilting, step-ups, squatting, weight shifting, mini-trampoline, limping cross, cloth under foot, kettlebell swings, side-lying jumping jacks, elastic band exercises, and gait training exercises. Each exercise will progress through three levels based on the patients cognition and tolerance throughout the session. All exercises will be performed in 2 sets of 12 repetitions. Each session will conclude with a 10-minute cool-down period that involves walking with focus on alignment and stretching for the lower extremity muscles. Participants will attend a total of 3 sessions per week for 8 weeks, totaling 24 sessions. |
| Intervention |
Experimental Group: Neuromuscular control exercise with Kinesio taping |
The participants will begin with a 10-minute warm-up that includes ergometer cycling, treadmill, or stepper. The neuromuscular exercises will include quadriceps and hamstrings strengthening, lunging, pelvic tilting, step-ups, squatting, weight shifting, mini-trampoline, limping cross, cloth under foot, kettlebell swings, side-lying jumping jacks, elastic band exercises, and gait training exercises. Each exercise will progress through three levels based on the patients cognition and tolerance throughout the session. All exercises will be performed in 2 sets of 12 repetitions. Each session will conclude with a 10-minute cool-down period that involves walking with focus on alignment and stretching for the lower extremity muscles. Kinesio taping will be applied 3 times weekly for 8 weeks. Before application, the skin will be cleaned. Participants will lie on their side with the hip extended and the knee flexed to 60°. An I-shaped kinesio tape will be placed from the origin of the rectus femoris, and a Y-shaped tape will be applied proximal to the superior patellar border. The tape will have no tension at its base, while the section between the anchor and the superior patella will be stretched to about 40%. After 48 hours, the tape will be removed, and each participant will be assessed for skin sensitivity. Participants will attend a total of 3 sessions per week for 8 weeks, totaling 24 sessions. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Participants will be included if: patients between the ages of 45 and 75 years, knee OA diagnosis according to the American College of Rheumatology, Kellgren-Lawrence index of II and III, and sign the informed consent form. |
|
| ExclusionCriteria |
| Details |
Participants will be excluded if: systemic inflammatory arthritis, oral steroid treatment in the last 3 months, history of physical therapy or corticosteroid injections at the knee in the last 6 months, previous knee surgery, neurological deficits in the lower extremities, central or peripheral nervous system disease, the cardiopulmonary disease that would prevent exercise, and any contraindication for KT (extensive and severe skin injuries, open wounds with risk of infection, allergic reactions, and pregnancy). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain intensity on VAS in resting and walking, Pain sensitivity on an algometer, and Function on WOMAC |
At baseline, week-8, and week-20 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Muscle strength by Dynamometer, Range of motion by Goniometer, and Functional mobility by the Timed Up and Go test |
At baseline, week-8, and week-20 |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="0"
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 1 |
|
Date of First Enrollment (India)
|
04/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/09/2025 |
| 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
|
This randomized
controlled trial will compare the effects of neuromuscular control exercises
with and without Kinesio taping on pain and function in patients aged 45–75
years with knee osteoarthritis (Kellgren–Lawrence grade II–III). Participants
will be randomly allocated to an experimental group receiving exercises plus
Kinesio taping or a control group receiving exercises alone, with both groups
completing 24 sessions over 8 weeks. Primary outcomes are pain (VAS at rest and
walking), pain sensitivity (algometer), and function (WOMAC). Secondary
outcomes include muscle strength, range of motion, and functional mobility
(Timed Up and Go test), measured at baseline, week 8, and week 20. |