IRCT | Effect of 6 weeks of neuromuscular exercise on knee varus thrust, muscle activity and pain during descending the stairs in people with early knee osteoarthritis with varus thrust

Protocol summary

Study aim: Investigating the effect of 6 weeks of neuromuscular exercises on knee varus thrust, muscle activity and pain when going down stairs in people with early knee osteoarthritis combined with varus thrust
Design: Through a public advertisement, volunteers with early knee osteoarthritis will be invited to check the inclusion criteria. 30 volunteers with early knee osteoarthritis (Early KOA) with Kellgren-Lawrence grade less than 2, who also have varus thrust of the knee will be randomly allocated to one of two control or intervention groups.
Settings and conduct: The initial evaluation will be done at the Research-Treatment Center for Movement Disorders, Physiotherapy Department, Tarbiat Modares University. After checking the inclusion criteria, people will be randomly assigned to one of the two groups (Intervention/control). Before starting the therapeutic interventions and after 6 weeks, the outcome measures will be evaluated.
Participants/Inclusion and exclusion criteria: Patient with early knee osteoarthritis with varus thrust. There should be no other musculoskeletal diseases, neuromuscular diseases, obesity, severe genu varus or genu valgus, and a history of injection or knee surgery.
Intervention groups: In the control group, the traditional quadriceps setting exercises will be done, and neuromuscular exercises will be done in the test group. Both groups will do the exercises for 6 weeks and 3 sessions per week every other day. One session per week will be under the therapist's supervision and the rest of the sessions will be controlled at home.
Main outcome variables: Pain, muscle activity and strength, the value of the varus thrust (knee adduction excursion & velocity), knee moment, the impulse of the knee moment, center of pressure displacement, and velocity.

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20101017004952N12

Registration date: 2024-05-10, 1403/02/21

Registration timing: prospective

Last update: 2024-05-10, 1403/02/21

Update count: 0
Registration date: 2024-05-10, 1403/02/21

Registrant information: Name

Giti Torkaman

Name of organization / entity

Tarbiat Modares University

Country

Iran (Islamic Republic of)

Phone

+98 21 8288 4509

Email address

torkamg@modares.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2024-06-21, 1403/04/01
Expected recruitment end date: 2025-01-20, 1403/11/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Effect of 6 weeks of neuromuscular exercise on knee varus thrust, muscle activity and pain during descending the stairs in people with early knee osteoarthritis with varus thrust

Public title: Effect of 6 weeks of neuromuscular exercise on knee varus thrust, muscle activity and pain during descending the stairs in people with early knee osteoarthritis with varus thrust
Purpose: Health service research
Inclusion/Exclusion criteria: Inclusion criteria:

- Early knee osteoarthritis (grade 1-2) - Presence of varus thrust in the knee - BMI (body mass index) between 22 and 30 - The ability to go down the stairs without an aid - radiographic control and rejection of other lower limb musculoskeletal injuries

Exclusion criteria:

- Other musculoskeletal diseases and damage to lower limb joints (such as rheumatic diseases, neuropathy, diabetic neuropathy) - Neuromuscular diseases (such as Parkinson's, hemiplegia, multiple sclerosis) - Genovalgom more than 5 degrees and genovarum more than 10 degrees - History of knee joint surgery - History of joint injections during the last 6 months - A history of cardio-respiratory disorders that prevent therapeutic exercises. - The patient can withdraw from the study at any stage and for any reason, if he does not want to cooperate.
Age: No age limit
Gender: Both

Phase

N/A

Groups that have been masked

Outcome assessor

Sample size

Target sample size: 30

Randomization (investigator's opinion)

Randomized

Randomization description

The randomization method is done using sealed opaque envelopes through blocks of four, where two people are assigned to each group in each block. This will be done by someone independent of the research team.

Blinding (investigator's opinion)

Single blinded

Blinding description

The participant in each group is unaware of the types of intervention in the other group. The assessor who also performs the data extraction is blind.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Tarbiat Modares University

Street address

Tarbiat Modares University, Jalal Al Ahmad Street

City

Tehran

Province

Tehran

Postal code

1411713116
Approval date: 2024-05-05, 1403/02/16
Ethics committee reference number: IR.MODARES.REC.1402.252

Health conditions studied

1

Description of health condition studied: Early knee osteoarthritis
ICD-10 code: M15.0
ICD-10 code description: Primary generalized (osteo)arthritis

Primary outcomes

1

Description: Knee adduction excursion
Timepoint: Beginning and end of 6 weeks of therapeutic exercise
Method of measurement: The difference between the knee adduction angle at the moment of heel contact and the maximum knee adduction angle during the stance phase with a 3D motion capture device

2

Description: Pain
Timepoint: Beginning and end of 6 weeks of therapeutic exercise
Method of measurement: Using Visual Analogue Scale (VAS) and WOMAC questionnaire

3

Description: Quadriceps, hamstring and gastrocnemius muscle activity
Timepoint: Beginning and end of 6 weeks of therapeutic exercise
Method of measurement: Using electromyography system

4

Description: Knee adduction velocity
Timepoint: Beginning and end of 6 weeks of therapeutic exercise
Method of measurement: Change of knee adduction angle per unit of time with a 3D motion capture device

5

Description: External moments of the knee joint
Timepoint: Beginning and end of 6 weeks of therapeutic exercise
Method of measurement: During step-down, the knee moments were measured through the inverse dynamics method and using a three-dimensional motion capture system.

6

Description: Strength of knee flexor and extensor and hip abductor muscles
Timepoint: Beginning and end of 6 weeks of therapeutic exercise
Method of measurement: Using a digital hand-held dynamometer and through MMT, the muscle strength of knee flexor and extensor and hip abductor will be measured.

Secondary outcomes

1

Description: Displacement and velocity of the center of pressure sway
Timepoint: Beginning and end of 6 weeks of therapeutic exercise
Method of measurement: During 20 seconds of a double stance on the force plate.

Intervention groups

1

Description: Control group: In this group, the traditional exercises for people with knee osteoarthritis, namely strengthening the quadriceps muscle, will be performed in the form of quadriceps setting exercises (QS). These exercises will include 5 exercises: Quadriceps over a roll, Knee extension in sitting, Knee extension with a hold at 30° knee flexion, Straight leg raising, and Outer range knee extension. In all the above exercises, the contraction is maintained for 6 seconds with 6-12 seconds of rest between them. They will be done for 6 weeks and 3 sessions per week, they will perform exercises every other day (18 sessions) and from these sessions, 1 session per week (6 sessions, total) will be performed under the supervision of a therapist and the rest of the sessions (12 sessions) will be performed under control of a physiotherapist at home. In the first week, each exercise is done in a set of 10. For the progression of the training over time, in the second week, a weight cuff or a weight will be used around the ankle, with 1% of the body mass. In the third week, the number of repetitions of each exercise will be increased to 2 sets of 10. In the fourth week, the weight used will become 2% of body weight. In the fifth week, the number of repetitions of each exercise will be increased to 3 sets of 10. In the sixth week, the weight will become 3% of the body weight.
Category: Rehabilitation

2

Description: Intervention group: In this group, neuromuscular exercises will include 6 exercises (Forward and backward sliding or stepping, Sideways exercises, Functional hip muscle strengthening, Functional knee muscle strengthening, Step-ups and down balance with single leg stance). The progress of the exercises will be by adding repetitions and increasing the traband stiffness. They will be done for 6 weeks and 3 sessions per week, they will perform exercises every other day (18 sessions). In all the above exercises, the contraction is maintained for 6 seconds with 6-12 seconds of rest between them. One session per week (6 sessions, total) will be performed under the supervision of a therapist and the rest of the sessions (12 sessions) will be performed under the control of a physiotherapist at home. In the first week, training will be done with 10 repetitions in one set. From the second week, an elastic band or theraband will be used to progress the exercise by applying varus force during movement. In the supervision therapy session at the beginning of each week, the band with a higher degree of stiffness will be selected. In the third week, the exercise will be performed in 2 sets with 10 repetitions with the band applying the varus force. In the fourth week, the teraband used will be chosen to be a stiffer degree. In the fifth week, training will be done in 3 sets with 10 repetitions. In the sixth week, the teraband used will become one degree harder.
Category: Rehabilitation

Recruitment centers

1

Recruitment center: Name of recruitment center

Department of Physiotherapy, Tarbiat Modares University

Full name of responsible person

Giti Torkaman

Street address

Jalal Ale-Ahmad Street, Tarbiat Modares Uniersity

City

Tehran

Province

Tehran

Postal code

1411713116

Phone

+98 21 8288 4509

Fax

Email

torkamg@modares.ac.ir

Web page address

https://www.modares.ac.ir

1

Sponsor: Name of organization / entity

Tarbiat Modares University

Full name of responsible person

Amir Abdollah zadeh

Street address

Tarbiat Modares University, Jalal Al Ahmad Street

City

Tehran

Province

Tehran

Postal code

1411713116

Phone

+98 21 8288 2009

Fax

+98 21 8288 6544

Email

pres@modares.ac.ir

Web page address

http://www.modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Tarbiat Modares University
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Tarbiat Modares University

Full name of responsible person

Giti Torkaman

Position

Professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiotherapy

Street address

Tarbiat Modares University, Jalal Ale-Ahmad Street

City

Tehran

Province

Tehran

Postal code

1411713116

Phone

+98 21 8288 4509

Fax

Email

torkamang@yahoo.com

Web page address

http://www.modares.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Tarbiat Modares University

Full name of responsible person

Giti Torkaman

Position

Professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiotherapy

Street address

Tarbiat Modares University, Jalal Ale-Ahmad Street

City

Tehran

Province

Tehran

Postal code

1411713116

Phone

+98 21 8288 4509

Fax

Email

torkamang@yahoo.com

Web page address

http://www.modares.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Tarbiat Modares University

Full name of responsible person

Fatemeh Farahzadi

Position

PhD student

Latest degree

Master

Other areas of specialty/work

Physiotherapy

Street address

Tarbiat Modares University, Jalal Ale- Ahmad Street

City

Tehran

Province

Tehran

Postal code

1411713116

Phone

+98 21 8288 4509

Fax

Email

justlikefa@gmail.com

Web page address

http://www.modares.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: No - There is not a plan to make this available
Data Dictionary: No - There is not a plan to make this available
Title and more details about the data/document: demographic data, main variable and its consequences
When the data will become available and for how long: 6 month after publication results
To whom data/document is available: only for researchers
Under which criteria data/document could be used: they do not have permission to process the data
From where data/document is obtainable: justlikefa@gmail.com 09125044931 Fatemeh Farahzadi
What processes are involved for a request to access data/document: He/she must by email indicate the title of the research proposal and the reason for the request.
Comments

Effect of 6 weeks of neuromuscular exercise on knee varus thrust, muscle activity and pain during descending the stairs in people with early knee osteoarthritis with varus thrust