| CTRI Number |
CTRI/2019/06/019698 [Registered on: 17/06/2019] Trial Registered Prospectively |
| Last Modified On: |
21/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study done to assess quadriceps muscle strength production with ankle joint in three different positions. |
|
Scientific Title of Study
|
Comparative study on quadriceps strength production with different ankle positions in osteoarthritis of knee. An observational analytical study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali Shirish Kale |
| Designation |
MPT Student |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Musculoskeletal Physiotherapy Department, Sancheti Healthcare Academy , 11/12,Thube park, Shivajinagar, Pune, Maharashtra
Pune
MAHARASHTRA
411005
India |
| Phone |
9768256664 |
| Fax |
|
| Email |
anjalikale345@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venu Mohan |
| Designation |
Associate professor of Musculoskeletal physiotherapy Department |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Healthcare Academy , 11/12,Thube park, Shivajinagar, Pune, Maharashtra
Pune
MAHARASHTRA
411005
India |
| Phone |
9440690707 |
| Fax |
|
| Email |
venumohan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjali Shirish Kale |
| Designation |
MPT Student |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Musculoskeletal Physiotherapy department, Sancheti Healthcare Academy , 11/12,Thube park, Shivajinagar, Pune, Maharashtra
Pune
MAHARASHTRA
411005
India |
| Phone |
9768256664 |
| Fax |
|
| Email |
anjalikale345@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute College of Physiotherapy, 11/12 Thube Park, Shivajinagar, Pune |
|
|
Primary Sponsor
|
| Name |
Anjali Shirish Kale |
| Address |
Sancheti Institute College of Physiotherpay, 11/12 Thube Park, Shivajinagar , Pune |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anjali Kale |
Sancheti Institute of Orthopedic Rehabilitation |
Department: Physiotherapy,
Musculoskeletal OPD,Sancheti Institute of Orthopedic Rehabilitation, 11/12 Thube park, Shivajinagar, Pune, Maharashtra 411005
Pune
MAHARASHTRA |
9768256664
anjalikale345@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Review Board Sancheti Institute for Orthopedic and Rehabilitation PUNE Agenda 054 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Grade 2 & 3 according to Kellgren and Lawrencesystem.
Numerical pain rating scale score 6 or less.
|
|
| ExclusionCriteria |
| Details |
Any limitation in the ankle range of motion, history of bony or soft tissue injury to knee joint, backache with radiating pain to leg, any central or peripheral nervous system involvement, systemic inflammatory disease e.g. Gout, Rheumatoid arthritis, Ankylosing spondylitis, had metallic implants, uncooperative patient, mentally unstable patient, subjects with BMI ≥40 kg/m2 (morbid obesity). |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quadriceps strength assessed using dynamometer with ankle in neutral postion and dorsiflexion |
Immediate |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quadriceps strength assessed using dynamometer with ankle in plantarflexion |
Immediate |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/06/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
People suffering from osteoarthritis of knee will be selected according to inclusion and exclusion criteria from out patients department of tertiary care hospitals and their willingness to participate in study. Participants will be informed about entire research protocol. Written consent will be taken. Demographic data will be taken along with height, weight and numerical pain rating scale. In case of bilateral involvement of knee both joints will be assessed individually , according to fulfilment of inclusion criteria. Subjects will perform 5 minutes warm up session which will include spot marching, spot jogging followed by stretching of quadriceps, hamstrigs, calf muscles and hip adductors. The subjects will then be asked to sit on HUV quadriceps table where foot rest will be already set at 60Ⱐof knee flexion angle for the side which is going to be assessed. Participant will keep his leg ( the leg which is going to be assessed) on that foot rest and another leg will be relaxed with knee in 90Ⱐof flexion. Microfet 3 dynamometer will be kept just above medial malleolus. Participant will perform isometric knee extension with maximum force against dynamometer. Dynamometer will be stabilised by belt stabilisation method which will also provide resistance for isometric contraction of knee extensors. Belt stabilisation method provides stabilisation to dynamometer as well as it provides constant resistance for each participant. So subjective mistakes created due to assessor’s strength will be eliminated. Participant will perform isometric contraction of knee extensors with ankle in three joint positions i.e. neutral joint position, dorsiflexion position and plantar flexion position. Three readings will be taken at every joint position and mean of those readings will be taken. Participant will hold each contraction position for 5 seconds. Measurements will be taken from mean of each position.Data will be analysed using one way anova. Results will be obtained. |