| CTRI Number |
CTRI/2021/09/036607 [Registered on: 17/09/2021] Trial Registered Prospectively |
| Last Modified On: |
26/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Knee pain |
|
Scientific Title of Study
|
Effectiveness of task specific exercise training versus graded motor imagery in participants with knee osteoarthritis- A randomized clinical trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhura Suhas Joshi |
| Designation |
PG student |
| Affiliation |
KAHER institute of physiotherapy |
| Address |
KLEs KAHER institute of physiotherapy, jnmc campus , nehru nagar, belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
7774075764 |
| Fax |
|
| Email |
madhurajoshi1498@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kage |
| Designation |
Vice Principal Of Kaher institute pf physiotherapy and HOD of Orthopedic Physiotherapy |
| Affiliation |
|
| Address |
KLEs KAHER institute of physiotherapy, jnmc campus , nehru nagar, belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
vijaykage@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Madhura Suhas Joshi |
| Designation |
PG student |
| Affiliation |
|
| Address |
KLEs KAHER institute of physiotherapy, jnmc campus , nehru nagar, belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
madhurajoshi1498@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kles Dr. Prabhakar Kore hospital and reasearch centre, nehru nagar belgavi |
|
|
Primary Sponsor
|
| Name |
Kaher institute of physiotherapy |
| Address |
KLEs KAHER institute of physiotherapy, jnmc campus , nehru nagar, belgaum |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Madhura Joshi |
KAHER institute of physiotherapy |
KLE KAHER institute of physiotherapy, jnmc campus , nehru nagar, belgaum
Belgaum
KARNATAKA |
7774075764
madhurajoshi1498@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethical committee kaher institute of physiotherapy |
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 |
| Intervention |
Subject in group a will be receiving task specific exercise training |
9 sessions along with conventional treatment program will be given 10 repetitions per set for 3-4 sets for each component will be given. |
| Comparator Agent |
Subject in group B will be recieving graded motor imagery |
This group will receive Graded motor imagery along with conventional physiotherapy 9
sessions. Patients will be asked to perform the same at home every 2 hourly. A diary
will be provided to maintain the records for the same. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Radiological evidence of knee OA with Grade 2 on the Kellgren -Lawrence Scale.
Male and female between the age group of 40 years - 65 years
Moderate difficulty with the activities from the Knee injury and Osteoarthritis Outcome
Score (KOOS)
Participants complaining of pain severity according to NPRS score from 3 to 7 |
|
| ExclusionCriteria |
| Details |
Any deformity of knee , hip or back or any other Musculoskeletal problem , any kind of lower limb soft tissue injury
Any central or peripheral neuropathy in past 6 months
Patients recieving physiotherapy , knee injections in preceding 30 days |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Isokinetic testing system
Knee injury and osteoarthritis outcome score
Goniometer
Numerical pain rating scale
Performance based tasks |
Pre assent will be taken usong the outcome measures before the first session of treatment and post will be taken after the last session of the treatment.treatment will be given for 45 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/09/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
22/09/2021 |
| 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
|
To evaluate and compare the effects of task specific exercise training and graded motor imagery on outcome measures as peak muscle torque , angle and ratio for quadriceps and hamstring with isokinetic testing system, pain with nprs and functional disability with KOOS in subjects with knee osteoarthritis . Pre and post assessment will be taken before 1 st session and after 9th session respectively. |