| CTRI Number |
CTRI/2019/01/017049 [Registered on: 11/01/2019] Trial Registered Prospectively |
| Last Modified On: |
20/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of routienly done strengthening exercises versus joint position sence trining in patients with Early Osteoarthritis |
|
Scientific Title of Study
|
Effectiveness of Proprioceptive Training Versus
Conventional Exercises on Postural Sway in Patients
with Early Knee Osteoarthritis 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 |
Ashish John Prabhakar |
| Designation |
Asst Professor Senior Scale |
| Affiliation |
kasturba Medical College, Manguluru |
| Address |
Department of Physiotherapy, Center for Basic Sciences,
KMC, Bejai, Mangaluru. 575003
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
8123223092 |
| Fax |
|
| Email |
ashish.john@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogeesh D Kamat |
| Designation |
Consultant knee and hip surgeon, Sports Injury and Joint Replacement, Adjunct faculty, MAHE |
| Affiliation |
KMC Hospital |
| Address |
KMC Hospital,
Ambedkar Circle,
Mangaluru
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9591675577 |
| Fax |
|
| Email |
yogeesh.kamat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogeesh D Kamat |
| Designation |
Consultant Knee and Hip Surgeon, Sports Injury and Joint Replacement, Adjunct faculty, MAHE |
| Affiliation |
KMC Hospital |
| Address |
KMC hospital,
Ambedkar Circle,
mangaluru
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9591675577 |
| Fax |
|
| Email |
yogeesh.kamat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College,
Light House Hill Road,
Hampankatta,
Mangaluru 575001 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Mangaluru |
| Address |
203, Light house hill road, hampankatta, mangaluru, 575001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| self |
Department of Physiotherapy, Center for Basic Sciences, Bejai, Mangaluru, 575003 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ashish J Prabhakar |
Kasturba Medical College Hospital |
5th floor,Physiotherapy OPD,
Kasturba Medical College Hospital, Dr. B.R Ambedkar Circle, Balmatta,
Mangaluru, 575001
Dakshina Kannada
KARNATAKA |
8123223092
ashish.john@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics Committee kasturba medical college, mangaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 Exercise |
Conventional Strengthening Exercises and Electrotherapy will be given. |
| Intervention |
Proprioceptive Training |
Proprioceptive Training will be given using Trampoline, Medicine Ball and Electrotherapy will be given |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients presents with swelling/ pain/ stiffness/ loss of confidence.
Subject with clinically and radiological confirmed diagnosis of EOA by an Orthopaedician or a physician |
|
| ExclusionCriteria |
| Details |
1. If patients demonstrates with any neurological or musculoskeletal condition other than EOA, rheumatoid, other inflammatory arthritis.
2. Morbid obesity (BMI > 30 kg/m2)
3. Any previous surgery or medical management for EOA
4. Subjects with history of vertigo (vestibular dysfunction)
5. Patients with hypertension, other co-morbidities
6. K & L, grade 3 and above.
7. Recent surgeries and significant injuries of lower limb |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Force plate
Joint position sense |
Pre Treatment,
Post treatmet on 1st, 2nd, 3rd, 4th week and 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Muscle Strength (HHD), Pain (VAS), KOOS |
Pre Treatment,
Post treatment 1st, 2nd, 3rd, 4th week and 3rd month |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
21/01/2019 |
| 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="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
upon approval by the Institutional Ethics Committee of Kasturba Medical College Mangaluru, eligible patients will be recruited based on the inclusion and exclusion criteria. The purpose of study will be made clear to each patient and a written informed consent will be obtained prior to involving them in to the study. Following this, the patients will be allocated to groups, i.e conventional and interventional group by block randomization. Group information will be concealed in a sealed opaque envelope and revealed to the patients only after they are recruited into the treatment group or the control group. Following the allocation of the groups either conventional or interventional group. The primary investigator will note for postural sway using force plate, proprioception (joint position sense) using digital goniometer, muscle strength using hand held push pull dynamometer, pain using VAS and functional outcome using KOOS. These data will be recorded pre- treatment and post treatment every week till the fourth week and third month. |