| CTRI Number |
CTRI/2023/11/059407 [Registered on: 01/11/2023] Trial Registered Prospectively |
| Last Modified On: |
25/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Design, Development and Testing of An Innovative Device to Improve Knee Joint Movement |
|
Scientific Title of Study
|
Design, Development and Testing of Myomotion Corrector Device to Facilitate Knee Joint Mobility: An Exploratory Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Padsumbia |
| Designation |
Post graduate student |
| Affiliation |
R K University |
| Address |
School of Physiortherapy, RK University kasturbadham
Rajkot-Jamnagar Highway, Rajkot, Gujarat, India
Rajkot
GUJARAT
360020
India
Rajkot
GUJARAT
360020
India |
| Phone |
8469952276 |
| Fax |
|
| Email |
ppadsumbia905@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krupa Harikrishna Tank |
| Designation |
Assistant Professor, |
| Affiliation |
R K University |
| Address |
School of Physiortherapy, RK University kasturbadham
Rajkot-Jamnagar Highway, Rajkot, Gujarat, India
Rajkot
GUJARAT
360020
India
Rajkot
GUJARAT
360020
India |
| Phone |
9998810063 |
| Fax |
|
| Email |
krupa.tank@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Padsumbia |
| Designation |
Post graduate student |
| Affiliation |
R K University |
| Address |
School of Physiortherapy, RK University kasturbadham
Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India
Rajkot
GUJARAT
360020
India |
| Phone |
8469952276 |
| Fax |
|
| Email |
ppadsumbia905@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| Priyanka Padsumbia School of Physiotherapy , RK University, Kasturbadham ,
Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Priyanka Padsumbia |
| Address |
School of Physiotherapy , RK University, Kasturbadham ,
Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Priyanka Padsumbia PT |
RK Physiotherapy Rehabilitation and Research center |
Physiotherapy Department, Bhaktinagar circle
behind HDFC bank, Rajkot
Gujarat, India
Rajkot
GUJARAT
Rajkot
GUJARAT |
8469952276
ppadsumbia905@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, School of Physiotherapy, RK University, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional physiotherapeutic method |
compare Myomotion corrector device with conventional physiotherapeutic method i.e. putting sand bag over knee joint in long sitting position, patient in prone position with leg out of the plinth till mid thigh etc. which is used to treat reversible knee contracture |
| Intervention |
Myomotion Corrector Device |
compare Myomotion corrector device with conventional physiotherapeutic method i.e. putting sand bag over knee joint in long sitting position, patient in prone position with leg out of the plinth till mid thigh etc. which is used to treat reversible knee contracture. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Knee Joint Hypomobility
Extension Lag (in various condition like OA Knee, ACLR, TKR etc.)
Reversible Knee Flexor Contracture
Post Operative Knee Joint Stiffness
Positive Prone Passive Lag Test
|
|
| ExclusionCriteria |
| Details |
Permanent Fixed Flexion Deformity Of Knee
Open Wound around knee joint
Non Healed Scar around knee joint
Not Willing to participate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Active Knee Range Of Motion
|
Pre Outcome at Baseline (1st day of Treatment)
Post Outcome after 2 Weeks (Last Day of Treatment)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Lower Extremity Functional Scale (LEFS)
|
pre and post |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/11/2023 |
| 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="0"
Months="2"
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
|
Title: Design, Development and Testing of Myomotion Corrector Device to Facilitate Knee Joint Mobility: An Exploratory Study
Investigator: Dr Priyanka Padsumbia PT, Dr. Krupa Harikrishna Tank MPT Musculoskeletal, Phd Scholar, Assistant Professor, School of Physiotherapy, RK University
Background: The knee is a mobile joint and the available mobility or range of motion (ROM) determines its ability to engage in activities of daily living. The total knee ROM ranges from 0° extension to 140° flexion. Reversible knee flexion contracture is a knee that is unable to fully extend to 0°. Reversible Knee contracture is a common and severe complication after trauma, ligament reconstruction, knee arthritis and total knee arthroplasty (TKA). Scar tissue forms in the intra- and extra-articular regions after trauma or surgery, and the long immobilization time leads to quadriceps inhibition and aggravation of knee contractures. Patients with persistent reversible flexion contracture could possibly experience anterior knee pain and altered gait mechanics. More recently, the need for normal knee extension has been gaining importance. Abnormal flexion contracture can lead to abnormal higher energy expenditure of quadriceps muscle. A 15° flexion contracture led to a need for the quadriceps to contract with 22% more force than a fully extended knee; as the flexion contracture increased to 30°, the quadriceps had to contract with 50% more force. There were several conditions and complications that cause contracture of knee which includes Patella Tendon Repairs, Patella Fractures, Tibial Plateau Fractures, Total Knee Arthroplasty/Replacement, Quadriceps Repairs, Knee Arthroscopies.
Method: Following ethical approval, 50 subjects will be selected as per inclusion and exclusion criteria the outcome measure will be assessed with active range of motion of knee joint. lower limb function will be assessed by lower extremity functional scale. Post treatment assessment will be measured by universal goniometer.
Phase 1: Designing Myomotion Corrector Device to facilitate knee joint mobility. Phase 2: Developing Myomotion Corrector Device to facilitate knee joint mobility. Phase 3: Testing Myomotion Corrector Device to facilitate knee joint mobility. |