| CTRI Number |
CTRI/2024/10/075807 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Resistance training via Theraband and Conventional Exercise on patients with knee pain |
|
Scientific Title of Study
|
To Compare the Effect of Resistance Training
With Theraband
Versus Conventional Exercise on Pain And
Quality Of Life of the Patient with Knee OA |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ira Pandey |
| Designation |
MPT Student |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
Mahatma Gandhi Physiotherapy College,Mahatma Gandhi University of Medical Sciences and Technology,RIICO institutional area,Sitapura ,tonk road,jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9887742420 |
| Fax |
|
| Email |
ira2001@mgumst.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arvind Tomar |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
Orthopedic Physiotherapy Lab, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO institutional area, Sitapura, Tonk road, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9784805133 |
| Fax |
|
| Email |
drarvindtomar@mgumst.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arvind Tomar |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
Orthopedic Physiotherapy Lab, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO institutional area, Sitapura, Tonk road, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9784805133 |
| Fax |
|
| Email |
drarvindtomar@mgumst.org |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Physiotherapy College,Mahatma Gandhi University of Medical Sciences and Technology,RIICO institutional area,Sitapura ,tonk road,Jaipur, Rajasthan (India), 302022. |
|
|
Primary Sponsor
|
| Name |
Ira Pandey |
| Address |
D 27, Shanti Path, Tilak
Nagar, Jaipur, Rajasthan, India, 302004 |
| 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 Arvind Tomar |
Mahatma Gandhi Hospital, Jaipur |
Room No. 14 Physiotherapy OPD, Basement, Mahatma Gandhi hospital
Jaipur
RAJASTHAN |
09784805133
drarvindtomar@mgumst.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mahatma Gandhi Medical College and Hospital, MGUMST, Jaipur |
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 Exercises |
Patients will be given conventional exercises according to American Academy
of Orthopedic Surgeons [AAOS] guidelines and protocol for knee conditioning
which will include using sand bag for static quadriceps exercise, U/L straight
leg raise exercise in supine , U/L hamstring stretching exercises, Hip abduction
strengthening exercise , Hip adduction strengthening exercise ,U/L straight leg
raise exercise in prone, Knee extension exercise, Calf raise exercise, Ankle
pump.
These patient will attend the intervention program 10times for 45 minutes per
day for 4weeks |
| Intervention |
Resistance training with theraband |
Patients will be given conventional exercises according to American Academy
of Orthopedic Surgeons [AAOS] guidelines and protocol for knee conditioning
which will include knee extension, pelvic abduction , leg- press exercise.(18)
These patient will attend the intervention program 10 times for 45 minutes per
day for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Not involved in any physiotherapy treatment
2.Patient is willing to participate
3.Patient is able to follow all the commands |
|
| ExclusionCriteria |
| Details |
1.Inability to walk
2. Unstable Heart Conditions
3. Going to participate in another physical activity program
4. Epilepsy
5.Previous knee arthroplasty
6. Previous traumatic history
7. Other significant neurological and musculoskeletal disorder |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
VAS Scale
Goniometer
|
4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
VAS Scale
|
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The eligibility of the candidate will be taken from the basis of inclusion criteria. 30 subjects will be randomly selected and then consent form will be filled by eligible candidates after this they will be randomly allotted in these 2 groups . GROUP A – Resistance training with theraband Patients will be given conventional exercises according to American Academy of Orthopedic Surgeons [AAOS] guidelines and protocol for knee conditioning which will include knee extension, pelvic abduction , leg- press exercise. These patient will attend the intervention program 10 times for 45 minutes per day for 4 weeks. GROUP B- Conventional Exercises Patients will be given conventional exercises according to American Academy of Orthopedic Surgeons [AAOS] guidelines and protocol for knee conditioning which will include using sand bag for static quadriceps exercise, U/L straight leg raise exercise in supine , U/L hamstring stretching exercises, Hip abduction strengthening exercise , Hip adduction strengthening exercise ,U/L straight leg raise exercise in prone, Knee extension exercise, Calf raise exercise, Ankle pump. These patient will attend the intervention program 10times for 45 minutes per day for 4weeks |