CTRI

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CTRI Number

CTRI/2024/01/061392 [Registered on: 12/01/2024] Trial Registered Prospectively

Last Modified On:

10/05/2024

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Case Control Study

Study Design

Other

Public Title of Study

Leg muscle fitness in osteoarthritis

Scientific Title of Study

Relationship of Strength and Flexibility of Anterior and Posterior Leg Muscles with Knee Osteoarthritis

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Vivek Sharma
Designation	PG Scholar
Affiliation	Department Of Physiotherapy, AIHAS, Amity University Noida
Address	Department Of Physiotherapy, AIHAS, Amity University Noida Gautam Buddha Nagar UTTAR PRADESH 201313 India
Phone	9958043809
Fax
Email	Viveksharma1801.vs@gmail.com

Details of Contact Person
Scientific Query

Name	Prof.(Dr.) Jasobanta Sethi
Designation	Director
Affiliation	Department Of Physiotherapy, Amity Institute of Health Allied Sciences , Amity University Noida
Address	Room No-07 Lower Ground Floor,F-1 Block, Department Of Physiotherapy, Amity Institute of Health Allied Sciences ,Amity University Uttar Pradesh ,Sector-125,Noida-201301, INDIA Gautam Buddha Nagar UTTAR PRADESH 201301 India
Phone	9821662045
Fax
Email	jsethi@amity.edu

Details of Contact Person
Public Query

Name	Vivek Sharma
Designation	PG Scholar
Affiliation	Department Of Physiotherapy, AIHAS, Amity University Noida
Address	Department Of Physiotherapy, AIHAS, Amity University Noida Gautam Buddha Nagar UTTAR PRADESH 201313 India
Phone	9958043809
Fax
Email	Viveksharma1801.vs@gmail.com

Source of Monetary or Material Support

Amity university Physiotherapy clinic ,Sector 125, Noida, Uttar Pradesh 201303

Vyasa Polyclinic & Physiotherapy Rehabilitation Centre, C-72, Shaheed Rajguru Marg, opp. Reliance Mall, Block C, Vikaspuri, New Delhi, Delhi, 110018

Primary Sponsor

Name	Vivek Sharma
Address	Department Of Physiotherapy, AIHAS, Amity University Noida
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 2
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Vivek Sharma	Amity University Noida Physiotherapy Clinic	Room no.-1 ,Amity University Physiotherapy Clinic, Gate no-1 G8VM+H69, Amity Rd, Sector 125, Noida, Uttar Pradesh 201301 Gautam Buddha Nagar UTTAR PRADESH	9958043809 viveksharma1801.vs@gmail.com
Dr Vivek Sharma	Vyasa Polyclinic & Physiotherapy Rehabilitation Centre	Room no-1 ,Physiotherapy Department ,C-72, Shaheed Rajguru Marg, opp. Reliance Mall, Block C, Vikaspuri, New Delhi, Delhi, 110018 West DELHI	9958043809 viveksharma1801.vs@gmail.com

Details of Ethics Committee

No of Ethics Committees= 2
Name of Committee	Approval Status
INSTITUTIONAL NTCC ETHICAL COMMITTEE AMITY INSTITUTE OF HEALTH ALLIED SCIENCES,AMITY UNIVERSITY UTTAR PRADESH	Approved
Vyasa Polyclinic & Physiotherapy Rehabilitation Centre	No Objection Certificate

Regulatory Clearance Status from DCGI

Status

Not Applicable

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	Range of Motion Measurement	Measure the flexibility using universal goniometer for ankle until end range or possible range Measurement Will be Recorded once at starting of study for both Healthy Individuals and Knee Osteoarthritis Patients
Comparator Agent	Strength Measurement	Measure the strength of ankle using Handheld dynamometer for an isometric contraction for 10 seconds Measurement will be Recorded at starting of study for both Healthy Individuals and Knee Osteoarthritis Patients

Inclusion Criteria

Age From	55.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1. Diagnosed case of Knee osteoarthritis patients 2. Both male and female 3. Age 50-65 years 4. Grade 2,3,4 (Kellgren and Lawrence system) 5.Both obese and non-obese individuals 6. Matching patients with knee osteoarthritis based on age and gender with healthy participants who have no history of the condition.

ExclusionCriteria

Details

1. Any recent trauma to the knee joint, ankle joint or area surrounding it.
2. Grade 1(Kellgren and Lawrence system)
3. Any neurological deficit patients
4. Any infections around knee and ankle
5. Any surgery of knee joint
6. Rheumatoid arthritis
7. Lower-limb surgery
8. Amputation
9. Rupture or trauma to the muscles of leg.
10. Anybody who refuses to participate in the study.

Method of Generating Random Sequence

Other

Method of Concealment

Not Applicable

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
Strength of Anterior and Posterior leg muscles	Baseline

Secondary Outcome

Outcome	TimePoints
Flexibility of anterior & posterior leg muscles	Baseline

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60"

Phase of Trial

N/A

Date of First Enrollment (India)

19/01/2024

Date of Study Completion (India)

29/04/2024

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="2"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

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
Modification(s)

NEED OF THE STUDY

Patients suffering from knee osteoarthritis are known to have deficiencies in their quadriceps and hamstring muscles. However, research studies on the characteristics of the anterior and posterior lower leg muscle are scarce.

Hence the investigators intent to explore about the strength and flexibility of the anterior and posterior leg muscle in patient with knee osteoarthritis in Indian population.

So far in the literature, little is known about the strength and flexibility of the anterior and posterior leg muscle in individuals with knee osteoarthritis in Indian population. Therefore, our study will provide greater insight about the strength and flexibility of anterior and posterior lower leg muscles of individuals with knee osteoarthritis in Indian population.

SIGNIFICANCE

The study will give an insight on the outcome about the strength and flexibility in patient with knee osteoarthritis.

This will give Clinician fraternity a new information which they can use in their patient care.

Also, the patient can be benefited from this new information for prevention and treatment.

AIM: To study the relationship of strength and flexibility of anterior and posterior leg muscles with knee osteoarthritis.

OBJECTIVE

To find out the relationship of strength and flexibility of anterior and posterior leg muscles with knee osteoarthritis.

Hypothesis

1. Null hypothesis- There is no significant correlation between the strength and flexibility of anterior and posterior leg muscles with knee osteoarthritis.

2. Alternate hypothesis- There is significant correlation between the strength and flexibility of anterior and posterior leg muscles with knee osteoarthritis.

INSTRUMENTS REQUIRED-

1.Universal Goniometer-for measuring flexibility of muscles

2. Cable Tensiometer -for measuring strength of muscles

GROUP ALLOCATION:

The subjects will be separated into two groups: an experimental group and a control group.

Experimental group -Patients who are diagnosed with Knee Osteoarthritis.

Control group - Healthy adults, who are not diagnosed with Knee Osteoarthritis.

All the measurement of strength and flexibility measurements of anterior and posterior leg muscles will be measured using the described instruments and will be finally computed for statistical analysis.