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CTRI Number  CTRI/2023/11/059640 [Registered on: 07/11/2023] Trial Registered Prospectively
Last Modified On: 06/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized Factorial Trial 
Public Title of Study   TO LOOK FOR THE EFFECT OF FOCUSSED EXERCISES IN KNEE OSTEOARTHRITIS PATIENTS AFTER KNEE REPLACEMENT SURGERY 
Scientific Title of Study   EVALUATING THE IMPACT OF FOCUSSED REHABILITATION ON GAIT PARAMETERS IN PATIENTS OF CHRONIC OSTEOARTHRITIS OF KNEE THREE MONTHS AFTER 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  RAMEESHA SHIRIN K 
Designation  JUNIOR RESIDENT 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR 
Address  GROUND FLOOR DEPARTMENT OF PMR ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR BASNI PHASE 2,JODHPUR RAJASTHAN

Jodhpur
RAJASTHAN
342005
India 
Phone  8921193856  
Fax    
Email  rameeshashirin1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR RAVI GAUR 
Designation  ADDITIONAL PROFESSOR AND HOD, DEPARTMENT OF PMR 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR 
Address  GROUND FLOOR DEPARTMENT OF PMR ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR BASNI PHASE 2,JODHPUR RAJASTHAN

Jodhpur
RAJASTHAN
342005
India 
Phone  8299711753  
Fax    
Email  ravisms80@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR RAVI GAUR 
Designation  ADDITIONAL PROFESSOR AND HOD, DEPARTMENT OF PMR 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR 
Address  GROUND FLOOR DEPARTMENT OF PMR ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR BASNI PHASE 2,JODHPUR RAJASTHAN


RAJASTHAN
342005
India 
Phone  8299711753  
Fax    
Email  ravisms80@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR 
 
Primary Sponsor  
Name  RAMEESHA SHIRIN K 
Address  GROUND FLOOR DEPARTMENT OF PMR ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR BASNI PHASE 2, JODHPUR 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
RAMEESHA SHIRIN K  GROUND FLOOR, DEPARTMENT OF PMR, ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR  GROUND FLOOR DEPARTMENT OF PMR ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR BASNI PHASE 2, JODHPUR
Jodhpur
RAJASTHAN 		 8921193856

rameeshashirin1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, ALL INDIA INSTITUTE OF MEDICAL SCIENCE, JODHPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 REHABILITATION  GIVE CONVENTIONAL REHABILITATION FOR TOTAL KNEE REPLACEMENT SURGERY PATIENTS. It includes: Full weight bearing training, walking with help of walker, continuous passive motion (from full extension to 90-100 degrees of flexion) and active range of movements, quadriceps and hamstrings strengthening exercises. It will be then followed by exercises targeting on recovery of full range of movements of knee, recovery of proprioception, techniques for scar-tissue remodelling, gait training, stair climbing and walking without aids.  
Intervention  FOCUSSED REHABILITATION  GIVE FOCUSSED REHABILITATION FOR TOTAL KNEE REPLACEMENT SURGERY PATIENTS. It includes: 1.Quadriceps and VMO Neuromuscular Electrical Stimulation [NMES] using Russian current 2.Core strengthening 3.Hip flexors muscles strengthening 4.Gluteal muscle strengthening 5.Strengthening of gastrocnemius and soleus complex 6.Stretching of quadriceps, rectus femoris and tensor fascia lata 7.Lumbar extensor strengthening 8.Posture analysis and correction 9.Gait training and re-education  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Chronic knee osteoarthritis patients who are scheduled for total knee replacement
surgery 
 
ExclusionCriteria 
Details  1. Non-ambulatory status of the patient.
2. Patients with limb length discrepancy
3. Prior history of surgery in lower limb
4. Patients with any other bony pathology like fractures, symptomatic OA of other joints
in lower limb
5. Patients with known lower limb neuropathy, radiculopathy and muscular dystrophy
6. Patients with serious neurological or psychiatric disorders
7. Patients with advanced respiratory or cardiovascular disease 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the impact of focussed rehabilitation versus conventional rehabilitation on gait parameters- cadence, step length, speed and single support time in patients of chronic osteoarthritis of knee after three months of procedure using gait and motion analysis laboratory.  NOVEMBER 2023-JUNE 2025 
 
Secondary Outcome  
Outcome  TimePoints 
To compare pain improvement in patients receiving focussed rehabilitation versus
conventional rehabilitation before and after three months of TKR using 11-point Numerical Rating Scale [NRS] and pain component of Knee Injury and Osteoarthritis Outcome Score [KOOS].  		 NOVEMBER 2023-JUNE 2025 
To compare pain improvement in patients receiving focussed rehabilitation versus
conventional rehabilitation before and after three months of TKR using Quality of life (QoL) component of Knee Injury and Osteoarthritis Outcome Score [KOOS] 		 NOVEMBER 2023-JUNE 2025 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   14/11/2023 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rameeshashirin1@gmail.com].

  6. For how long will this data be available start date provided 11-11-2023 and end date provided 11-11-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is going to be a single blinded randomised control trial in patients diagnosed with chronic knee osteoarthritis who are scheduled for total knee replacement surgery. All the Patients who satisfied the inclusion and exclusion criteria will undergo evaluation according to predesigned patient proforma and then undergo gait analysis using gait and motion analysis laboratory in PMR department. The patients will be then divided into two groups as experimental group and a control group by single blinded randomisation using randomisation table. All the patients then will undergo TKR by orthopaedic surgeon who will not be involved in the evaluation process, as per schedule in department of Orthopaedics. Then the patients will be allocated in either of the two defined groups- conventional or conventional with focussed rehabilitation for three months as per randomisation. They will be followed up with respect to gait, pain and quality of life after 3 months of rehabilitation. 
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