FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/089953 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 30/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of home-based rehabilitation post total knee replacement with sensor device 
Scientific Title of Study   Enhancing home-based rehabilitation for knee stiffness post total knee replacement: A novel approach with wearable motion sensor device 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Preeti Mohanty 
Designation  Assistant Professor (senior scale) 
Affiliation  Manipal Institute of Technology 
Address  Department of Instrumentation and Control Engineering,Manipal Institute of Technology, MAHE

Udupi
KARNATAKA
576104
India 
Phone  9886616682  
Fax    
Email  mohanty.preeti@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Preeti Mohanty 
Designation  Assistant Professor (senior scale) 
Affiliation  Manipal Institute of Technology 
Address  Department of Instrumentation and Control Engineering,Manipal Institute of Technology, MAHE

Udupi
KARNATAKA
576104
India 
Phone  9886616682  
Fax    
Email  mohanty.preeti@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Preeti Mohanty 
Designation  Assistant Professor (senior scale) 
Affiliation  Manipal Institute of Technology 
Address  Department of Instrumentation and Control Engineering,Manipal Institute of Technology, MAHE

Udupi
KARNATAKA
576104
India 
Phone  9886616682  
Fax    
Email  mohanty.preeti@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education, Manipal, Udupi District, Karnataka, India, 576104 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  Manipal Academy of Higher Education, Manipal, Udupi District, Karnataka, India, 576104 
Type of Sponsor  Other [Institution of Eminence, deemed to be university] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Preeti Mohanty  Department of instrumentation and control engineering, MIT  MAHE, Manipal,
Udupi
KARNATAKA 		 09886616682

mohanty.preeti@manipal.edu 
Dr Rajesh Navada G V   Kasturba Hospital   Room Number: 101, Department of physiotherapy, Unit of Manipal Academy of Higher Education, Manipal,576104
Udupi
KARNATAKA 		 09886430431

rajesh.gv@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KasturbaMedicalCollege/KasturbaHospitalInstitutionalEthicalCommittee  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  Home program  control group-The patients will be given an exercise diary to note down the number of exercises, along with the frequency and number of days performed, and pictures of the exercises for reference. 
Intervention  sensor–assisted rehabilitation program.   Study group: All the parameters of exercise will be advised through the mobile app to which sensor sends the messages. The exercise program include 30-minute sessions twice a week, which has 2 face-to-face contacts at baseline and at the end of 8 weeks. The physio treatment will be: Ankle pumps, Inner range quadriceps, Isometric knee extension in the outer range, Knee and hip flexion/extension, Straight leg raises, Isometric buttock contraction, Hip abduction/adduction, Lower limb functional exercises, Walking with a frequency of 3 times /day, 5 sets of 20 repetitions.  
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Willing to participate in the study
Capable of managing a smartphone and medically stable.
Underwent total knee replacement for arthritic changes
Discharged from the hospital within 5to7 days.
Knee joint presentation (knee flexion lesser than 70 degrees, quadriceps strength lesser than 2plus, extension lag more than 5 degrees)
 
 
ExclusionCriteria 
Details  Post-op complications such as deep vein thrombosis, infection, or neurovascular disorde.
Fixed bony deformity in lower limbs, decreased flexibility of trunk, any musculoskeletal injury or surgery in lower limbs in the last one year  
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Range of motion, manual muscle test, visual analogue scale, Knee injury and Osteoarthritis Outcome Score (KOOS), 6 Minute Walk Test, Time up and go  baseine and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
independence of use
patient satisfaction
safety & adverse events 		 baseline & 8 weeks 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   01/08/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Pain and a limited range of motion (ROM) among patients undergoing total knee replacement (TKR) surgeries are common complaints during post-operative period. Proper rehabilitation at the community set up is utmost solution for improving joint health to attain the functional level. However, the potentiality for an effective treatment was not continued at home with the use of a particular approach due to various reasons resulting in post-operative joint complications.

When subjective evaluation is not possible in patients’ house, the technology-based monitoring system need to be developed. Some gold standard technology which is portable, wearable, low-cost, accessible to all is the present need of the time by means of sensors attached to knees to measure ROM. The wearable motion sensor device (WMSD) with interactive mobile apps to monitor in-home exercise progress, through wireless telerehabilitation technology and assist in tracking the ROM for knee joint and patient compliance. 

 
Close