| CTRI Number |
CTRI/2023/04/051550 [Registered on: 12/04/2023] Trial Registered Prospectively |
| Last Modified On: |
02/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A CLINICAL TRIAL TO FIND OUT THE EFFECT OF RESISTED EXERCISES IN IMPROVING WALKING PATTERN IN OA KNEE SUBJECTS |
|
Scientific Title of Study
|
EFFICACY OF PROGRESSIVE RESISTED TRAINING OF LOWER EXTREMITY MUSCLES AND CORE MUSCLES IN IMPROVING EARLY STAGE OSTEOARTHRITIS OF KNEE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SJ KANIMOZHISELVI |
| Designation |
RESEARCH SCHOLAR |
| Affiliation |
SRM COLLEGE OF PHYSIOTHERAPY SRMIST |
| Address |
SRM COLLEGE OF PHYSIOTHERAPY
SRM MEDICAL COLLEGE HOSPITALS AND RESEARCH CENTER KATTANKULATHUR CAMPUS
CHENGALPATTU,
Kancheepuram
TAMIL NADU
603230
India |
| Phone |
9003222893 |
| Fax |
|
| Email |
kaniroop@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SJ KANIMOZHISELVI |
| Designation |
RESEARCH SCHOLAR |
| Affiliation |
SRM COLLEGE OF PHYSIOTHERAPY SRMIST |
| Address |
SRM COLLEGE OF PHYSIOTHERAPY
SRM MEDICAL COLLEGE HOSPITALS AND RESEARCH CENTER KATTANKULATHUR CAMPUS
CHENGALPATTU,
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9003222893 |
| Fax |
|
| Email |
kaniroop@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SJ KANIMOZHISELVI |
| Designation |
RESEARCH SCHOLAR |
| Affiliation |
SRM COLLEGE OF PHYSIOTHERAPY SRMIST |
| Address |
SRM COLLEGE OF PHYSIOTHERAPY
SRM MEDICAL COLLEGE HOSPITALS AND RESEARCH CENTER KATTANKULATHUR CAMPUS
CHENGALPATTU,
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9003222893 |
| Fax |
|
| Email |
kaniroop@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM COLLEGE OF PHYSIOTHERAPY
SRM MEDICAL COLLEGE HOSPITALS AND RESEARCH CENTER KATTANKULATHUR CAMPUS
CHENGALPATTU, |
|
|
Primary Sponsor
|
| Name |
SJ KANIMOZHISELVI |
| Address |
SRM COLLEGE OF PHYSIOTHERAPY
SRM MEDICAL COLLEGE HOSPITALS AND RESEARCH CENTER KATTANKULATHUR CAMPUS
CHENGALPATTU, |
| 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 RADHIKA J |
SRM MEDICAL COLLEGE HOSPITALS AND RESEARCH CENTER |
DEPARTMENT OF PHSIOTHERAPY,1ST FLOOR.
Kancheepuram
TAMIL NADU |
9841190506
-
radhikaj@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ICING ROM EXERCISES – HIP , KNEE AND ANKLE STRAIGHT LEG RAISE EXERCISE STATIC QUADRICEPS EXERCISE |
DURATION - 30 - 45 MINS / SESSION , FOR 6-8 WEEKS , 3 DAYS/WEEK |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
PROGRESSIVE RESISTED EXERCISES FOR CORE MUSCLES AND THIGH MUSCLES (QUADRICEPS AND HAMSTRINGS ) |
DURATION - 30 - 45 MINS / SESSION , FOR 6-8 WEEKS , 3 DAYS/WEEK |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
40 – 70 years who gave their consent for the study are included
Both Male and female subjects are included
Grade 1 and 2 OA both unilateral and bilateral are to be included in this study
Radiographically assessed OA classified according to Kellgren and Lawrence score are included
|
|
| ExclusionCriteria |
| Details |
Acute septic arthritis
Acute fracture or inflammation
Those who received corticosteroids in past 3 months,
History of recent knee buckling,
Recent injuries
Total Knee Replacement
Neuropathic arthropathy and
Osteoporosis
|
|
|
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 |
To determine the effect of resisted exercises in improvement of gait parameters in subjects with early osteoarthritis.
|
Baseline 6 weeks and 8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PRE AND POST TEST-OUTCOME MEASURES
KOOS Physical Function scale
Gait Analysis – Gait on software
Surface EMG
TUG , 6 min. walk test
JAMAR HAND HELD DYNAMOMETER
To |
6-8 Weeks Program , 5 Days / week , 30 – 45 Mins / session , 3 sets 15 rep |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
14/05/2023 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
ØOsteoarthritis (OA) is a chronic degenerative joint disease which affects middle aged and older adults . ØSubjects with OA knee experience walking difficulties which interferes with their day to day activities due to muscle weakness . Hence, strengthening of muscles are needed to correct gait parameters Ø Reduced kinesthetic receptors in joint especially around the ligaments in the knee can lead to impaired proprioceptive information to an individual. ØCore muscle endurance deficiency leads to an increase in the loading of the knee, as well as in knee joint contact force during dynamic movement. Hence, poor core stability may be one of the contributing factors that lead to knee OA development as well as its progression . Lower limb muscle strength is related to core endurance. In subjects with OA knee, knee muscles may get weak and thus affect core endurance. Knee osteoarthritis (OA) causes changes not only in the tissues within the articular cavity, but also affects the ligaments, tendons, and periarticular tissues including the muscles. OA of the knee is known to be a risk factor for fall injuries. Therefore, it would be valuable for OA patients to receive rehabilitative training after evaluating their balance control abilities.ØMost of the osteoarthritis subjects are un aware of their gait change during their early stages . This study is to highlight these unnoticed changes in gait ØAccording to journals and studies Osteoarthritis occurs in older adults . But this study highlights the occurrence of OA in middle aged population also. ØCore strengthening is a major concern for change in gait patterns. This study involves in strengthening of core muscles to improving gait pattern. |