| CTRI Number |
CTRI/2024/07/070788 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| 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
|
Exploring exercise options for knee arthritis: effects on movement and pain relief |
|
Scientific Title of Study
|
To compare the effect of open and closed kinetic chain exercise versus muscle energy technique and isometric exercises to increase range of motion and decrease pain in patient with osteoarthritis knee |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ravindra Rana |
| Designation |
Post Graduate Student |
| Affiliation |
Shri Mahant Indresh Hospital, Patel Nagar, Dehradun |
| Address |
Room No-03, Department of Physiotherapy, North Block, Lower
Ground, Shri Mahant Indresh Hospital, Patel Nagar, Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
7300604599 |
| Fax |
|
| Email |
raviranagolu234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shama Praveen |
| Designation |
Assistant Professor |
| Affiliation |
Shri Mahant Indresh Hospital, Patel Nagar, Dehradun |
| Address |
Room No-03, Department of Physiotherapy, North Block, Lower
Ground, Shri Mahant Indresh Hospital, Patel Nagar, Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8006965111 |
| Fax |
|
| Email |
shamapraveen@sgrrmc.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shama Praveen |
| Designation |
Assistant Professor |
| Affiliation |
Shri Mahant Indresh Hospital, Patel Nagar, Dehradun |
| Address |
Room No-03, Department of Physiotherapy, North Block, Lower
Ground, Shri Mahant Indresh Hospital, Patel Nagar, Dehradun
UTTARANCHAL
248001
India |
| Phone |
8006965111 |
| Fax |
|
| Email |
shamapraveen@sgrrmc.com |
|
|
Source of Monetary or Material Support
|
| Shri Mahant Indresh Hospital, Patel Nagar, Dehradun
|
|
|
Primary Sponsor
|
| Name |
Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences |
| Address |
Department of Physiotherapy North Block, Lower Ground Shri
Mahant Indresh Hospital Patel Nagar Dehradun |
| Type of Sponsor |
Private medical college |
|
|
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 Ravindra Rana |
Shri Mahant Indresh Hospital |
Room No-03, Department of Physiotherapy, Lower Ground, Shri
Mahant Indresh Hospital, Patel Nagar, Dehradun
Dehradun
UTTARANCHAL |
7300604599
raviranagolu234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, Shri Guru Ram Rai Institute of Medical and Health Sciences, Patel Nagar, Dehradun |
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 |
isometric exercises and muscle energy technique |
In this exercise routine, the session starts with a 5-minute warm-up that includes knee lifts, leg bends and lifts, heel raises, and toe raises. These activities help prepare the muscles for the main part of the workout. The focus then shifts to isometric exercises, which involve contracting specific muscle groups without actually moving the joints. This part of the session includes exercises targeting the quadriceps, adductors, hamstrings, and knee muscles, lasting a total of 35 minutes. Following the isometric exercises, the muscle energy technique is employed, combining post-isometric relaxation (done in 2 sets of 5 repetitions) and reciprocal inhibition (also done in 2 sets of 5 repetitions). These techniques aim to improve muscle function and joint mobility, helping to alleviate symptoms and promote overall muscle health.
The session will be of 25 minutes 3 days a week for 6 weeks
|
| Intervention |
open and close kinematic chain exercise |
Over three weeks, this rehabilitation program aims to enhance balance, strength, and agility for knee arthritis patients. Week one focuses on foundational balance exercises like standing with eyes closed on both hard ground and a soft mat, along with various walking challenges. Week two introduces a wobble board for added balance training and includes functional movements like sitting-to-standing and plyometric jumps. In week three, exercises progress to walking heel-to-toe on a marked line and performing single-leg raises for muscle strengthening. Plyometric jumps continue to enhance explosive power throughout the program, aiming to improve overall stability and mobility for the patient.
The session will be of 25 minutes 3 days a week for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Age 40-60 years
2 Age related Pathological osteoarthritis knee (Destruction of articular
cartilage,thickening of the subchondral bone,osteophyte.)
3 Both men and women sex groups.
4 Patients with Grade 2 Osteoarthritis knee. |
|
| ExclusionCriteria |
| Details |
1 Any traumatic injury of knee (fracture,dislocation,tears,sprain)
2 Knee Bone tumor
3 Other knee joint pathologies eg. Chondromalacia patella, plica syndrome,
Neurological disorders.
4 Post surgical knee patients. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical pain rating scale |
1st week
mid week
6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| WOMAC |
1st week
Mid week
6th week |
| Digital Inclinometer |
1st week
mid week
6th week |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
20/07/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
I will do research on “open and close kinematic chain exercise VS muscle energy
technique and isometric exercises to increase range of motion and decrease pain
inpatient with osteoarthritis knee.
Plan of work is as follows:
Total 36 patients will be included in the study by conventional sampling method.
Subjects will be divided into two groups with 18 subjects in each groups.
Group A will receive open and close chain exercise.
Group B will receive muscle energy technique and isometric exercises.
The study will be accorded from Shri Mahant Indresh Hospital, department of
physiotherapy Patel Nagar, dehradun.
The subjects will be undertaken according to the inclusion and exclusion criteria and a
written informed consent will be obtained a detail briefing will be given to the family
subjects about the purpose of the stud |