Knee OsteoarthritisNCT05855681
Effect Of Strengthening Hip Rotators And Ankle Muscles On Knee Osteoarthritis
A study testing therapeutic exercises in people with Knee Osteoarthritis, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- therapeutic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 15 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Knee Osteoarthritis
- Being tested
- therapeutic exercises
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic exercisesOther
strengthening exercise and stretching exercise
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | 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 Receives: Other: therapeutic exercises |
| control group | Other | patients will receive strengthening exercises for quadriceps and stretching exercise for hamstring and calf muscle. Receives: Other: therapeutic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain level
assessed by visual analogue scale
Measured: 4 weeks
functional level
assessed by Knee injury and Osteoarthritis Outcome Score
Measured: 4 weeks
knee proprioception
assessed by joint position sense
Measured: 4 weeks
Secondary outcomes (3)
Hip internal and external rotator strength
assessed by handheld dynamometer
Measured: 4 weeks
Ankle dorsi flexors, planter flexor, invertor and evertor strength
assessed by handheld dynamometer
Measured: 4 weeks
Quadriceps strength
assessed by handheld dynamometer
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Aug 2023
- Primary completion15 Oct 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Triple blinded Randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Osama Mohammed Galal ALSaadawy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855681
- Sponsor's protocol ID
- P.T.REC/012/004359
- Status last verified
- Oct 2023
- First submitted
- 4 May 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Strengthening Hip Rotators And Ankle Muscles On Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05855681
- Acronym / sponsor ID
- P.T.REC/012/004359
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Triple blinded Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: therapeutic exercisespatients 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 |
| control group | Other | Other: therapeutic exercisespatients will receive strengthening exercises for quadriceps and stretching exercise for hamstring and calf muscle. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic exercisesstrengthening exercise and stretching exercise | Other | control group, experimental group |
Primary outcome
pain level
Time frame: 4 weeks
assessed by visual analogue scale
functional level
Time frame: 4 weeks
assessed by Knee injury and Osteoarthritis Outcome Score
knee proprioception
Time frame: 4 weeks
assessed by joint position sense
3 secondary outcomes
Hip internal and external rotator strength
Time frame: 4 weeks
Ankle dorsi flexors, planter flexor, invertor and evertor strength
Time frame: 4 weeks
Quadriceps strength
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic exercises in people with Knee Osteoarthritis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain level (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.