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CTRI Number  CTRI/2023/02/049448 [Registered on: 06/02/2023] Trial Registered Prospectively
Last Modified On: 05/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Comparison Trial]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Core vs hip strengthening on knee function in adults with OA knee  
Scientific Title of Study   Effect of core versus hip strengthening on knee function in adults with Osteoarthritis knee: A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shilpshree Palsule 
Designation  Assisstant Professor 
Affiliation  Seth GS medical college and KEM hospital 
Address  first floor, 412,Occupational therapy school and training centre, Seth GS medical college and KEM hospital, Opposite TATA hospital, Parel,Mumbai Mumbai MAHARASHTRA 400012 India
first floor, 412,Occupational therapy school and training centre, Seth GS medical college and KEM hospital, Opposite TATA hospital, Parel,Mumbai Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400012
India 
Phone  9987798660   
Fax    
Email  sppalsule@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shilpshree Palsule 
Designation  Assisstant Professor 
Affiliation  Seth GS medical college and KEM hospital 
Address  first floor, 412,Occupational therapy school and training centre, Seth GS medical college and KEM hospital, Opposite TATA hospital, Parel,Mumbai Mumbai MAHARASHTRA 400012 India
first floor, 412,Occupational therapy school and training centre, Seth GS medical college and KEM hospital, Opposite TATA hospital, Parel,Mumbai Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400012
India 
Phone  9987798660   
Fax    
Email  sppalsule@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vrushali Prabhakar Jadhav 
Designation  1st year PG student 
Affiliation  Seth GS medical college and KEM hospital 
Address  first floor, 412,Occupational therapy school and training centre Seth GS medical college and KEM hospital, Opposite TATA hospital, Parel, Mumbai MAHARASHTRA 400012 India
first floor, 412,Occupational therapy school and training centre Seth GS medical college and KEM hospital, Opposite TATA hospital, Parel, Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400013
India 
Phone  08691941521  
Fax    
Email  vrushalijadhav52@gmail.com  
 
Source of Monetary or Material Support  
Occupational therapy School and training centre Seth GS Medical college and KEM hospital, Mumbai 
 
Primary Sponsor  
Name  no sponsor 
Address  not applicable 
Type of Sponsor  Other [not applicable] 
 
Details of Secondary Sponsor  
Name  Address 
none  none 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vrushali Jadhav  Occupational therapy School and training centre, Seth GS Medical college and KEM Hospital  Department of Occupational therapy, OPD no 412,First Floor, Orthopedic Centre, Opposite tata hospital, Parel, Mumbai- 400012
Mumbai
MAHARASHTRA 		 8691941521

vrushalijadhav52@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Core stability intervention along with Conventional Occupational therapy intervention for OA knee  0-2 week 1- Static abdominals 2- Bridging 3- Abdominal curls with arms outstretched 4- Sitting on therapy ball 2-4 week 1- Quadruped static abdominals 2- Bridging with unilateral straight leg raise 3- Abdo curls with arm behing the head 4- Sitting on therapy ball and transferring objects on the floor 4-6 weeks 1- Quadruped static abdominals 2- Bridging with marching 3- Abdo curls with arms across the chest 4- Sitting on therapy ball transferring objects with feet off the ground. Convectional Occupational therapy Intervention is as follows: Conventional occupational therapy treatment for Osteoarthritis Knee24,26,27: 1) Patient Education 2) Joint Protection Techniques and Fatigue Management – Advise on ADL 3) Stationary cycling 4) Passive, Active Assistive or Active ROM 5) Multiple angle isometrics for quadriceps and Hamstrings 6) Isotonic strengthening of knee flexors and extensor muscles using progressive resistive exercises and enabling activities. 7) Use of assistive device for ambulation if necessary 8) Ambulation Training- Practice walking on variety of terrains and inclines, including changes of directions first with assistance then independently 9) Functional Adaptations such as advise on use of commode for toilet purpose 10) Functional training- Climbing steps, sitting down, rising up from chair and commodes, using safe body mechanics to lift objects from the floor. 11) Balance Activities for Static and Dynamic Balance.  
Intervention  Hip strengthening along with Convectional Ocupational therapy intervention for OA knee  0-2 weeks 1- Static gluteus 2- Clam shell exercise 3- Wall squats 4- Step ups 2-4 weeks 1- Standing hip extension with 0.5kg weight cuff on the ankle 2- Clam shell with mild resistance TheraBand 3- Sit to stand with 90degree hip flexion 4- Step up with increasing height 4-6 weeks 1- Standing hip extension using 1kg weight cuff on the ankle 2- Clamshell with moderate resistance TheraBand 3- Sit to stand with weight in the hand 4- Step up with weight in the hand Convectional Occupational therapy Intervention is as follows: Conventional occupational therapy treatment for Osteoarthritis Knee24,26,27: 1) Patient Education 2) Joint Protection Techniques and Fatigue Management – Advise on ADL 3) Stationary cycling 4) Passive, Active Assistive or Active ROM 5) Multiple angle isometrics for quadriceps and Hamstrings 6) Isotonic strengthening of knee flexors and extensor muscles using progressive resistive exercises and enabling activities. 7) Use of assistive device for ambulation if necessary 8) Ambulation Training- Practice walking on variety of terrains and inclines, including changes of directions first with assistance then independently 9) Functional Adaptations such as advise on use of commode for toilet purpose 10) Functional training- Climbing steps, sitting down, rising up from chair and commodes, using safe body mechanics to lift objects from the floor. 11) Balance Activities for Static and Dynamic Balance.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patient who gives consent
2) Age of 40 to 60 years.
3) Both male and female gender.
4) Primary OA knee, Subjects who have clinical and radiographic symptoms of knee OA according to Kellgren-Lawrence Classification of Osteoarthritis13 stage 1,2,3, but are not a candidate for total knee joint replacement surgery. (If grading for stage of OA knee is not available then opinion from Orthopaedic surgeon will be taken.)
5) Unilateral OA knee. Since bilateral knee involvement will have different effect on functional status.
 
 
ExclusionCriteria 
Details  1) Any major trauma or surgery to the symptomatic knee or lower limb, neuromuscular disorders, rheumatoid arthritis, gout, history of stroke, and cardiovascular disease, ligament injuries and lower extremity fractures.
2) Intra-articular corticosteroid injection within 6 months current or past (within 4 weeks) oral corticosteroid use.
3) Any diagnosed spinal pathology.
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1) To study the effect of core stability vs hip strengthening along with knee strengthening on Functional Outcome pre and post intervention using Knee Osteoarthritis Outcome Survey in patients with Osteoarthritis of knee (Primary Objective).
 		 evaluation will be done at baseline, 2 weeks, 4 weeks and 6 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
1) To study effect of core vs hip strengthening on functional mobility and strength using 30 sec. chair stand test.
2) To compare strength in both the groups using manual muscle testing by mod. Oxford scale/ dynamometer (if available)
 		 evaluation will be done at baseline, 2weeks, 4 weeks snd 6 weeks 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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)   10/02/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

                                                       Summary of protocol

Title: Effect of Core Vs Hip Strengthening on knee function in adults with Osteoarthritis of Knee- A Randomised Controlled Trial

Aim:       To determine the effect of supervised core stability and hip strengthening exercise along with conventional therapy program in patients with Osteoarthritis of knee.

Objectives:

1)           To study the effect of core stability vs hip strengthening along with knee strengthening on Functional Outcome pre and post intervention using KOOS in patients with Osteoarthritis of knee.

2)           To study effect of core vs hip strengthening on  functional mobility and strength using 30 sec. chair stand test.

3)           To compare strength in both the groups using manual muscle testing by mod. Oxford scale/ dynamometer.

Study Design: Randomised Controlled Trial/ Interventional Study.

Sampling technique: Convenient Sampling

Study Setting: The study will be conducted in Occupational Therapy Department of Tertiary care Hospital.

Inclusion criteria:

1)       Patient who gives consent

2)       Age of 40 to 60 years.

3)       Both male and female gender.

4)       Primary OA knee, Subjects who have clinical and radiographic symptoms of knee OA according to Kellgren-Lawrence Classification of Osteoarthritis13 stage 1,2,3, but are not a candidate for total knee joint replacement surgery. (If grading for stage of OA knee is not available then opinion from Orthopaedic surgeon will be taken)

5)       Unilateral Knee Osteoarthritis. Since bilateral knee involvement will have different effect on functional status.

Exclusion Criteria:

1)       Any major trauma or surgery to the symptomatic knee or lower limb, neuromuscular disorders, rheumatoid arthritis, gout, history of stroke, and cardiovascular disease, ligament injuries and lower extremity fractures.

2)       Intra-articular corticosteroid injection within 6 months current or past (within 4 weeks) oral corticosteroid use.

3)       Any diagnosed spinal pathology.

Methodology:

Ethics approval.

Sample size: 34 per group

Consent from Subject.

Patient will be evaluated on Outcome measures such as Knee Injury and Osteoarthritis Outcome Score (KOOS), 30 sec Chair stand test, at pre, at 2 weeks, at 4weeks and post intervention. Convenient Sampling will be used. Based on inclusion and exclusion criteria, subjects will be randomized to either group A(core) or B(hip). Both the groups will be given conventional occupational therapy treatment for Osteoarthritis Knee. Group A (core) will be given Focused core stability exercises along with enabling activities. Group B will be given Focused Hip strengthening exercises through enabling activities in supine, sitting, standing using Thera-band of graded resistance. Intervention will be given for 40mins to both the groups. Follow up for twice a week for 6 weeks is recommended for the patient. Evaluation will be done after every 2weeks. Pre and Post intervention assessment will be done and data will be collected, analysed and results will be derived.

Study Tools:

1)    Manual Muscle testing

2)    Knee Injury and Osteoarthritis Outcome Score (KOOS)

3)    30 second Chair Stand Test

 
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