| CTRI Number |
CTRI/2025/08/093797 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| 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
|
Proprioceptive Training and Traditional Physiotherapy Programs in Alleviating Kinesiophobia among Elderly Individual with Knee Osteoarthritis |
|
Scientific Title of Study
|
Effectiveness of Proprioceptive Training And Traditional Physiotherapy Treatment Program In Alleviating Kinesiophobia Among Elderly Individuals with Knee Osteoarthritis 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 |
RADHIKA PRAMOD AGRAWAL |
| Designation |
Post Graduate Student |
| Affiliation |
Datta meghe college of physiotherapy, nagpur |
| Address |
Datta meghe college of Physiotherapy, Nagpur
Department of Musculoskeletal Science OPD, Nagpur
Nagpur
MAHARASHTRA
425310
India |
| Phone |
07219523121 |
| Fax |
|
| Email |
sandhya.999111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Deshmukh |
| Designation |
Associate Professor & HOD, dept of Musculoskeletal sciences |
| Affiliation |
Datta meghe college of physiotherapy, nagpur |
| Address |
Datta meghe college of Physiotherapy, Nagpur
Nagpur
MAHARASHTRA
425310
India |
| Phone |
8888826093 |
| Fax |
|
| Email |
nehadeshmukh57@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Deshmukh |
| Designation |
Associate Professor & HOD, dept of Musculoskeletal sciences |
| Affiliation |
Datta meghe college of physiotherapy, nagpur |
| Address |
Datta meghe college of Physiotherapy, Nagpur
Nagpur
MAHARASHTRA
425310
India |
| Phone |
8888826093 |
| Fax |
|
| Email |
nehadeshmukh57@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Datta Meghe College of PT Nagpur |
| Address |
datta meghe college of PT, Nagpur |
| 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 |
| RADHIKA PRAMOD AGRAWAL |
Datta Meghe Medical college, Wanadongri,Nagpur |
Datta Meghe college of Physiotherapy, Wanadongri, Nagpur
Derpartment Of Musculoskeletal, Nagpur
Nagpur
MAHARASHTRA |
7219523121
sandhya.999111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-APN Wanadongri, Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL THERAPY |
PATIENT EDUCATION
ATM
KNEE ROM ECERCISE
Knee Muscle Flexibility Exercise
HIP AND KNEE MUSCLE STRENGTHENING EXERCISE |
| Intervention |
PROPRIOCEPTION TRAINING |
1. Patient Education
2. Conventional Therapy
3. Single leg stance.
4. Forward walking
5. Spot marching
6. Partial squatting exercise with both legs
7. Semi squats two leg stance
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 60 to 80years
2. Both males and females of age group
3. Subject having bilateral Knee Osteoarthritis
4. Radiologically Kellgren and Lawrence system of grading II, III & IV
5. Duration of bilateral Knee Osteoarthritis will be more than 3 months.
6. On NPRS pain rating equal to or more than 5/10.
7. 5-Times Sit to Stand time taken equal to or more than 12 seconds.
8. On TAMPA SCALE for Kinesiophobia score equal to or more than 37/68.
|
|
| ExclusionCriteria |
| Details |
1. Any cognitive impairment
2. lower limb injury of soft tissue
3. lower limb surgery
4. Recent history of trauma (4 months).
5. Subject having Unilateral Knee Osteoarthritis
6. Any Neurological impairment
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain Intensity: NPRS scale
2. Functional Activities: 5 times Sit to Stand
3. Kinesiophobia: TAMPA scale
|
1. Pain Intensity: NPRS scale
2. Functional Activities: 5 times Sit to Stand
3. Kinesiophobia: TAMPA scale
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/09/2025 |
| 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="1"
Months="0"
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
|
This study investigates the comparative effectiveness of proprioceptive training and conventional therapy programs in reducing kinesiophobia (fear of movement) among elderly individuals with knee osteoarthritis (KOA). Knee osteoarthritis often leads to pain, stiffness, and impaired joint function, which can contribute to fear of movement and avoidance of physical activities, further worsening disability. The research evaluates how proprioceptive training—focused on enhancing joint position sense, balance, and neuromuscular coordination—compares with traditional physiotherapy methods (such as strengthening, range of motion, and flexibility exercises) in improving psychological and functional outcomes. The study measures changes in kinesiophobia, pain intensity, and functional performance, aiming to determine which intervention provides better and earlier improvement. Findings are expected to show that while both approaches are beneficial, proprioceptive training offers superior results in reducing kinesiophobia, restoring confidence in movement, and improving quality of life among elderly KOA patients. |