| CTRI Number |
CTRI/2025/06/089427 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| 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
|
Role of before and after exercise program on a surgery where damaged parts of the knee joint are replaced to relieve pain and improve movement. |
|
Scientific Title of Study
|
Efficacy of bio psychosocial model with preoperative physiotherapy on pain, quality of life and functional outcomes following unilateral Total Knee replacement |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Vijay Kumar |
| Designation |
Senior Physiotherapist |
| Affiliation |
Dr S Vijay Kumar |
| Address |
Department of Joint Replacement and Orthopedics
Physiotherapy Division
Out patient Department
Room no 132
Tata Main Hospital
C Road West Northern Town
Bistupur Jamshedpur
831001 Jharkhand India
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
8092092097 |
| Fax |
|
| Email |
vijayphysio2006@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Vijay Kumar |
| Designation |
Senior Physiotherapist |
| Affiliation |
Dr S Vijay Kumar |
| Address |
Department of Joint Replacement and Orthopedics
Physiotherapy Division
Out patient Department
Room no 132
Tata Main Hospital
C Road West Northern Town
Bistupur Jamshedpur
831001 Jharkhand India
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
8092092097 |
| Fax |
|
| Email |
vijayphysio2006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Vijay Kumar |
| Designation |
Senior Physiotherapist |
| Affiliation |
Dr S Vijay Kumar |
| Address |
Department of Joint Replacement and Orthopedics
Physiotherapy Division
Out patient Department
Room no 132
Tata Main Hospital
C Road West Northern Town
Bistupur Jamshedpur
831001 Jharkhand India
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
8092092097 |
| Fax |
|
| Email |
vijayphysio2006@gmail.com |
|
|
Source of Monetary or Material Support
|
| TATA Main Hospital, C Road West, Northern Town
Bistupur, Jamshedpur
831001 Jharkhand INDIA |
|
|
Primary Sponsor
|
| Name |
TATA Main Hospital |
| Address |
C Road West Northern Town
Bistupur Jamshedpur
831001 Jharkhand India |
| 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 |
| Dr S Vijay Kumar |
Tata Main Hospital |
Department of Joint Replacement and Orthopedics
Physiotherapy Division
Out patient Department
Room no 132
Tata Main Hospital
C Road West Northern Town
Bistupur Jamshedpur
831001 Jharkhand India
Purbi Singhbhum
JHARKHAND |
8092092097
vijayphysio2006@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Tata Main Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Exercise Interventions |
Lower extremity muscle strength.
a. Hip abductors/hip adductors.
b. Knee extensors/knee flexors.
3.Post Operative Standard Total knee replacement Rehabilitation.
10 Repetitions 3 sets.
Lower extremity muscle strength.
a. Hip abductors/hip adductors.
b. Knee extensors/knee flexors.
Straight leg raises.
c. Foot and ankle pumps.
d. Ambulation - Weight bearing ,Stair climbing |
| Intervention |
Exercise Interventions.
Pain Coping Skill-Education. |
1.Preoperative Physiotherapy - Neuromuscular Training.
Frequency Thrice in a week.
Warming up. Cycling – 10 minutes.
Circuit program - 30 minutes .
a. Core stability exercises.
b. Postural awareness.
c. Functional exercises.
Lower extremity muscle strength.
a. Hip abductors/hip adductors.
b. Knee extensors/knee flexors.
Cooling down . 10 minutes.
a. Mobility exercises for the lower extremities.
b. Stretching exercises for the lower extremity muscles.
2.Pain Coping Skill Education.
Frequency Thrice in a week.
Time 15 minutes per Session.
a. Progressive muscle relaxation .
3.Post Operative Standard Total knee replacement Rehabilitation.
Dose:10 Repetitions 3 sets.
Frequency : Hospitalization phase : Daily.
After discharge : Thrice a week.
Lower extremity muscle strength.
a. Hip abductors/hip adductors.
b. Knee extensors/knee flexors. Straight leg raises
c. Foot and ankle pumps.
d. Ambulation - Weight bearing ,Stair climbing
|
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1 Sex Both Males and Females
2 Clinically diagnosed of Chronic severe Osteoarthritis Knee
3 Grade four Radiographic evidence of Kellgren and Lawrence system for classification
4 Persistent Pain |
|
| ExclusionCriteria |
| Details |
1. Neurological disorders.
2. Underwent prior surgeries in Lower extremities.
3. COPD Patients.
4. Major Medical Illness.
5. Recent Cardiovascular Events.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome: Pain.
|
T1 - Base line.
T2 - 4 weeks after surgery.
T3 - 8 weeks after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcomes:
Functional Mobility.
Walking Distance.
Pain coping Skill.
Quality of Life
|
T1 - Base line.
T2 - 4 weeks after surgery.
T3 - 8 weeks after surgery |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
07/07/2025 |
| 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 focuses on the preoperative and postoperative unilateral Total knee replacement rehabilitation. The recruitment is not yet started. it is planned to be started from 28 April 2024. The attempts of publication will be started after completion of statistical analysis. |