| CTRI Number |
CTRI/2025/12/099611 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Graded Motor Imagery- an exercise program on Pain, Mobility, Fear of Movement and Walking Pattern in People with Knee Osteoarthritis |
|
Scientific Title of Study
|
Effect of Graded Motor Imagery on Pain, Functional Mobility, Kinesiophobia and Kinematics in subjects with knee osteoarthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shrutika Singh |
| Designation |
PG Student |
| Affiliation |
SGT University |
| Address |
A-80 f.f. The Palladians, Sector-47, Gurgaon
Gurgaon
HARYANA
122018
India |
| Phone |
8851652831 |
| Fax |
|
| Email |
shrutikasingh885@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anushree Rai |
| Designation |
Assistant Professor |
| Affiliation |
SGT University |
| Address |
SGT University, School of Physiotherapy, Budhera, Gurgaon
Gurgaon
HARYANA
122505
India |
| Phone |
8937881164 |
| Fax |
|
| Email |
Anushree_sphy@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anushree Rai |
| Designation |
Assistant Professor |
| Affiliation |
SGT University |
| Address |
SGT University, School of Physiotherapy, Budhera, Gurgaon
Gurgaon
HARYANA
122505
India |
| Phone |
8937881164 |
| Fax |
|
| Email |
Anushree_sphy@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
| School of Physiotherapy, SGT University, Gurugram |
|
|
Primary Sponsor
|
| Name |
SGT University |
| Address |
SGT University, Chandu Budhera Gurugram, Haryana- 122505 |
| 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 |
| Dr Shrutika Singh PT |
SGT University |
B-block 4th floor, School of Physiotherapy, SGT University, Chandu Budhera Gurugram- 122505
Gurgaon
HARYANA |
8851652831
shrutikasingh885@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Faculty of Physiotherapy |
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 |
Conventional Physiotherapy (Home exercise program) |
Conventional physiotherapy home exercise program (40 min/day, 5 days/week, 4 weeks) including warm-up, conditioning, stretching and cool-down exercises. |
| Intervention |
Graded Motor Imagery and Conventional Physiotherapy (Home exercise program) |
A structured GMI program for 4 weeks consisting of
• Laterality recognition (15–20 min/day, 5 days/week, 1 week)
• Explicit motor imagery (20 min/day, 5 days/week, 1 week)
• Mirror therapy (20 min/day, 5 days/week, 2 weeks)
Combined with:
• Conventional physiotherapy home exercise program (40 min/day, 5 days/week, 4 weeks) including warm-up, conditioning, stretching and cool-down exercises. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Adults aged 40 years and above diagnosed with knee osteoarthritis based on clinical and radiological criteria (Kellgren-Lawrence grading)
2) Diagnosis of knee osteoarthritis: Radiological confirmation with Kellgren Lawrence grade 2 to 4
3) Pain level: Chronic knee pain for at least 3 months with pain score more than or equal to 4 on VAS
4) Functional mobility limitation: Reduced functional mobility, assessed using WOMAC, physical function subscale or the Timed Up and Go (TUG) test
5) Kinesiophobia presence: Fear of movement as assessed by the Tampa Scale for Kinesiophobia (TSK) |
|
| ExclusionCriteria |
| Details |
1) Other Joint Conditions:
Presence of rheumatoid arthritis, gout, psoriatic arthritis, or any inflammatory arthritis.
2) Neurological or Musculoskeletal Disorders:
Conditions affecting motor function or sensory perception (e.g., stroke, Parkinson’s disease, multiple sclerosis, peripheral neuropathy).
3) Recent Surgery or Invasive Treatment:
Total knee replacement or major knee surgery within the past 6 months.
4) Cognitive or Psychiatric Impairments
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
i) Gait- Kinematics
ii) Pain
iii) Functional mobility
iv) Kinesiophobia
|
Baseline and post intervention (after 4 weeks)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cognition |
Baseline and post intervention (after 4 weeks)
|
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/01/2026 |
| Date of Study Completion (India) |
02/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
SIGNIFICANCE OF THE STUDY Knee osteoarthritis (OA) is a major contributor to chronic pain, limited mobility, and disability, significantly impacting individuals’ quality of life. Conventional rehabilitation primarily emphasizes physical exercises and pain relief, often overlooking the central nervous system’s role in motor control and pain processing. Graded Motor Imagery (GMI) is a promising neurocognitive rehabilitation method that has demonstrated potential in improving motor function and managing pain. However, its effects on gait kinmeematics, functional mobility, and kinesiophobia in knee OA remain insufficiently studied. This research is essential as it seeks to generate scientific evidence on the effectiveness of GMI as a complementary approach for managing knee OA. By assessing its influence on gait kinematics, pain, functional mobility, and kinesiophobia, this study may contribute to the advancement of holistic, non-invasive, and easily accessible treatment strategies. Furthermore, it could assist healthcare professionals in incorporating neurocognitive rehabilitation techniques into conventional therapy, ultimately enhancing patient outcomes. The findings from this study could lead to the development of innovative rehabilitation interventions, promoting improved mobility, reducing disability, and enhancing the overall well-being of individuals affected by knee OA. |