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Effect Of Strengthening Hip Rotators And Ankle Muscles On Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
therapeutic exercises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Chronic Knee osteoarthritis with pain for more than 3 months. Age between 40-55 years . BMI 25 - 34.9 Kellgren _ Lawrence grad1,2,3 . Subjects must be referred to the outpatient clinic of the faculty of Physical Therapy, Cairo University with a confirmed diagnosis of unilateral or bilateral (knee with primary affection included) knee osteoarthritis and having one or more of the following criteria: Morning stiffness for less than 30 min. Crepitus on active knee movement. Palpable or radiographic bony enlargement. Tenderness at joint margins or joint line. Knee pain over 30 mm on the Visual analogue scale. Exclusion Criteria: - 1- Physical therapy treatment for hip, knee and ankle in the last month. 2-Steroid knee injections in the previous 3 months. 3- hyaluronic acid intraarticular injections in the previous 6 months. 4- History of knee, ankle or hip surgery in the last 2 years. 5- Severe knee malalignment in varus or valgus that requires use of any gait-assistive device. 6- Neurological disease in lower limb 7- Inflammatory arthritis (eg: rheumatoid arthritis). 8- Ankle instability

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

experimental group

control group

Arm Description

patients will receive strengthening exercise for hip rotators and ankle muscles in addition to quadriceps strengthening . stretching exercise for hamstring and calf muscle also will be received

patients will receive strengthening exercises for quadriceps and stretching exercise for hamstring and calf muscle.

Outcomes

Primary Outcome Measures

pain level
assessed by visual analogue scale
functional level
assessed by Knee injury and Osteoarthritis Outcome Score
knee proprioception
assessed by joint position sense

Secondary Outcome Measures

Hip internal and external rotator strength
assessed by handheld dynamometer
Ankle dorsi flexors, planter flexor, invertor and evertor strength
assessed by handheld dynamometer
Quadriceps strength
assessed by handheld dynamometer

Full Information

First Posted
May 4, 2023
Last Updated
October 23, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05855681
Brief Title
Effect Of Strengthening Hip Rotators And Ankle Muscles On Knee Osteoarthritis
Official Title
Effect Of Strengthening Hip Rotators And Ankle Muscles On Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
October 15, 2023 (Actual)
Study Completion Date
October 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The goal of this clinical trial is to investigate the effect of adding strengthening exercise for hip rotators and ankle muscles to knee exercises on pain, function, muscles strength , and knee proprioception in patients with knee osteoarthritis. The main question it aims to answer is: What is the effect of adding strengthening exercise for hip rotators and ankle muscles to knee exercises on pain, function, strength of hip rotators and ankle muscles, and knee proprioception in patients with knee osteoarthritis?" Adult male and female diagnosed with unilateral or bilateral knee osteoarthritis, referred from orthopedic surgeons according to inclusion and exclusion criteria will be enrolled in this study, randomly allocated to groups and received exercise for 4 weeks. Control group Patients in this group will receive knee exercises in the form of stretching for hamstring and calf. Strengthening exercises in form of strengthening exercise for quadriceps. Experimental group In addition to the same knee exercise of control group patients will receive strengthening exercise for hip rotators and ankle muscles.
Detailed Description
The purpose of the current study is to investigate the effect of adding strengthening exercise for hip rotators and ankle muscles to knee exercises on pain, function, strength of muscles, and knee proprioception in patients with knee osteoarthritis. Adult male and female diagnosed with unilateral or bilateral knee osteoarthritis, referred from orthopedic surgeons according to inclusion and exclusion criteria will be enrolled in this study, randomly allocated to groups and received exercise for 4 weeks. Control group Patients in this group will receive knee exercises in the form of stretching for hamstring and calf. Strengthening exercises in form of strengthening exercise for quadriceps. Experimental group In addition to the same knee exercise of control group patients will receive strengthening exercise for hip rotators and ankle muscles. Recruited subjects will be screened with consideration of the inclusion and exclusion criteria. Aim of the study and all testing procedures will be verbally explained for eligible subjects and all relevant questions will be answered. If they agreed to participate in the study, an informed consent will be signed . Then, basic demographic information will be collected and patients will start the test. We will measure pain using visual analogue scale, functional level of the knee using Arabic Knee injury and Osteoarthritis Outcome Score questionnaire, isometric muscle strength of quadriceps, hip external and internal rotators, dorsi flexors, planter flexors, evertors and invertor muscles of ankle will be measured by handheld dynamometer and finally knee proprioception will be measured by assessing joint position sense by digital inclinometer. All these measurements will be done at base line and after (4 week) at the end of the treatment program. All patients will receive knee exercises according to guidelines and previous studies in the form of strengthening exercises that progress from 50% of the repetition maximum at first 2 week to 70% of 1 repetition maximum at last weeks, and from mild and moderate Thera band resistance in the first 2 weeks to maximum resistance in the last 2 weeks. In addition to knee muscle strengthening exercises,the experimental group will receive hip rotators and ankle muscles strengthening exercises. Passive stretching for hamstring and calf muscles will be done at the end of all exercises. Stretching will be performed three repetitions per session, holding each stretch for 30 seconds, with 10-seconds rest in between. All exercises will be performed for 30 to 45 minutes per session, 3 times per week for 4 weeks (12 sessions).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Triple blinded Randomized controlled trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Triple (Participant, Investigator, Outcomes Assessor) (assessor by research assistant, patients and statistician)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
patients will receive strengthening exercise for hip rotators and ankle muscles in addition to quadriceps strengthening . stretching exercise for hamstring and calf muscle also will be received
Arm Title
control group
Arm Type
Other
Arm Description
patients will receive strengthening exercises for quadriceps and stretching exercise for hamstring and calf muscle.
Intervention Type
Other
Intervention Name(s)
therapeutic exercises
Intervention Description
strengthening exercise and stretching exercise
Primary Outcome Measure Information:
Title
pain level
Description
assessed by visual analogue scale
Time Frame
4 weeks
Title
functional level
Description
assessed by Knee injury and Osteoarthritis Outcome Score
Time Frame
4 weeks
Title
knee proprioception
Description
assessed by joint position sense
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Hip internal and external rotator strength
Description
assessed by handheld dynamometer
Time Frame
4 weeks
Title
Ankle dorsi flexors, planter flexor, invertor and evertor strength
Description
assessed by handheld dynamometer
Time Frame
4 weeks
Title
Quadriceps strength
Description
assessed by handheld dynamometer
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic Knee osteoarthritis with pain for more than 3 months. Age between 40-55 years . BMI 25 - 34.9 Kellgren _ Lawrence grad1,2,3 . Subjects must be referred to the outpatient clinic of the faculty of Physical Therapy, Cairo University with a confirmed diagnosis of unilateral or bilateral (knee with primary affection included) knee osteoarthritis and having one or more of the following criteria: Morning stiffness for less than 30 min. Crepitus on active knee movement. Palpable or radiographic bony enlargement. Tenderness at joint margins or joint line. Knee pain over 30 mm on the Visual analogue scale. Exclusion Criteria: - 1- Physical therapy treatment for hip, knee and ankle in the last month. 2-Steroid knee injections in the previous 3 months. 3- hyaluronic acid intraarticular injections in the previous 6 months. 4- History of knee, ankle or hip surgery in the last 2 years. 5- Severe knee malalignment in varus or valgus that requires use of any gait-assistive device. 6- Neurological disease in lower limb 7- Inflammatory arthritis (eg: rheumatoid arthritis). 8- Ankle instability
Facility Information:
Facility Name
Cairo University
City
Giza
Country
Egypt

12. IPD Sharing Statement

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Effect Of Strengthening Hip Rotators And Ankle Muscles On Knee Osteoarthritis

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