Knee OsteoarthritisNCT05941117
Effect of Exercises on Dynamic Balance in Knee Osteoarthritis Patients.
A study testing stretching exercises, Transcutaneous electrical nerve stimulation and weight bearing strengthening exercises in people with Knee Osteoarthritis, run by Cairo University at 1 site in Egypt.
Trial summary
This study is a randomized controlled trial which aims to compare the effect of weight bearing exercises and non-weight bearing exercises on the dynamic balance in knee osteoarthritis patients as 60 patients will divided in three groups where one group is control group and others two groups one of them perform weight… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- stretching exercises, Transcutaneous electrical nerve stimulation and weight bearing strengthening exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Oct 2022to 15 Jun 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient's age > 50 years.
- Recent radiographs confirming the presence of knee OA, grade II-III (mild to moderate) Kellgren Lawrence (K/L).
- Body mass index (BMI) from 20 to 30 kg/m2.
- Met the American College of Rheumatology clinical criteria for mild to moderate knee OA.
- knee pain > 3 cm on a 10 cm visual analog scale (VAS) on most days of the previous week.
- Bilateral knee osteoarthritis.
Who cannot join
- Congenital or acquired inflammatory or neurological (systemic or local) diseases involving the knee.
- Patients who have mental or cognitive illness that interfere their ability to perform the exercises or the evaluation tests.
- Intra articular knee injection of steroids in the past 6 months.
- Patients who had received joint replacement surgery in either Knee or hip.
- Patients with rheumatoid arthritis.
- Patients who received physical therapy sessions on the knee in the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Weight Bearing Versus Non-weight Bearing Strengthening Exercises on Dynamic Balance in Knee Osteoarthritis Patients.
This study is a randomized controlled trial which aims to compare the effect of weight bearing exercises and non-weight bearing exercises on the dynamic balance in knee osteoarthritis patients as 60 patients will divided in three groups where one group is control group and others two groups one of them perform weight bearing exercises and the other perform non weight bearing exercises.
- Conditions
- Knee Osteoarthritis
- Being tested
- stretching exercises, Transcutaneous electrical nerve stimulation, weight bearing strengthening exercises, Non-weight bearing strengthening 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.
stretching exercisesCombination product
stretching exercises for Hamstring, quadriceps and calf muscle for both lower limbs of the same patients. each exercise was repeated 5 times and each repetition hold for 30 seconds in the same session.
Transcutaneous electrical nerve stimulationCombination product
Also called TENS
it is one of the electrical stimulation modalities which is used to relief pain, each patient receive it on both knees every session.
weight bearing strengthening exercisesCombination product
strengthening exercises for quadriceps, gluteus maximus, gluteus Medius and calf muscle in the form of weight bearing from standing position each exercise was repeated for 10 times with 5 seconds hold in the same set and patient perform three sets in the same session for both lower limbs.
Non-weight bearing strengthening exercisesCombination product
strengthening exercises for quadriceps, gluteus maximus, gluteus Medius and calf muscle in the form of non-weight bearing from lying and setting positions each exercise was repeated for 10 times with 5 seconds hold in the same set and patient perform three sets in the same session for both lower limbs.
| Study group | Role | What they receive |
|---|---|---|
| weight bearing exercises group | Active comparator | 20 patients were assigned to this group with bilateral knees osteoarthritis, they received TENS, stretching exercises and weight bearing strengthening exercises. Receives: Combination Product: stretching exercises; Combination Product: Transcutaneous electrical nerve stimulation; Combination Product: weight bearing strengthening exercises |
| non-weight bearing exercises group | Active comparator | 20 patients were assigned to this group with bilateral knees osteoarthritis, they received TENS, stretching exercises and Non-weight bearing strengthening exercises. Receives: Combination Product: stretching exercises; Combination Product: Transcutaneous electrical nerve stimulation; Combination Product: Non-weight bearing strengthening exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
change happened in the dynamic balance from the baseline
Biodex Balance System which is a device used to measure the balance of a person who stand on the platform of the device that give a measurement called over all stability index where 0 score means the best balance and the largest number indicate bad balance.
Measured: one day after the end of treatment
Secondary outcomes (2)
change happened in pain from the baseline
Visual Analog Scale which is a scale for pain from 0 to 10 where 0 mean no pain and 10 is the maximum pain.
Measured: one day after the end of treatment
change happened in the joint angle repositioning from baseline
Joint Repositioning Accuracy where the knee is moved passively to a certain angel and the patient hold it in this angle and then it moved to the start position and then the patient asked to move his knee joint actively to the previous the same previous angle then the absolute error between the true angle and the reproduced angle is measured.
Measured: one day after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start25 Oct 2022
- Primary completion15 Jun 2023
- Study completion15 Jun 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mahmoud Eldesoky, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941117
- Sponsor's protocol ID
- P.T.REC/012/003919
- Status last verified
- Jul 2023
- First submitted
- 25 Jun 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Weight Bearing Versus Non-weight Bearing Strengthening Exercises on Dynamic Balance in Knee Osteoarthritis Patients.
- ClinicalTrials.gov ID
- NCT05941117
- Acronym / sponsor ID
- P.T.REC/012/003919
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 12 Jul 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.
This study is a randomized controlled trial which aims to compare the effect of weight bearing exercises and non-weight bearing exercises on the dynamic balance in knee osteoarthritis patients as 60 patients will divided in three groups where one group is control group and others two groups one of them perform weight bearing exercises and the other perform non weight bearing exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| weight bearing exercises group | Active comparator | Combination Product: stretching exercises, Combination Product: Transcutaneous electrical nerve stimulation, Combination Product: weight bearing strengthening exercises20 patients were assigned to this group with bilateral knees osteoarthritis, they received TENS, stretching exercises and weight bearing strengthening exercises. |
| non-weight bearing exercises group | Active comparator | Combination Product: stretching exercises, Combination Product: Transcutaneous electrical nerve stimulation, Combination Product: Non-weight bearing strengthening exercises20 patients were assigned to this group with bilateral knees osteoarthritis, they received TENS, stretching exercises and Non-weight bearing strengthening exercises. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient's age > 50 years.
- Recent radiographs confirming the presence of knee OA, grade II-III (mild to moderate) Kellgren Lawrence (K/L).
- Body mass index (BMI) from 20 to 30 kg/m2.
- Met the American College of Rheumatology clinical criteria for mild to moderate knee OA.
- knee pain > 3 cm on a 10 cm visual analog scale (VAS) on most days of the previous week.
Key exclusion criteria (6 listed)
- Congenital or acquired inflammatory or neurological (systemic or local) diseases involving the knee.
- Patients who have mental or cognitive illness that interfere their ability to perform the exercises or the evaluation tests.
- Intra articular knee injection of steroids in the past 6 months.
- Patients who had received joint replacement surgery in either Knee or hip.
- Patients with rheumatoid arthritis.
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 |
|---|---|---|
| stretching exercisesstretching exercises for Hamstring, quadriceps and calf muscle for both lower limbs of the same patients. each exercise was repeated 5 times and each repetition hold for 30 seconds in the same session. | Combination product | non-weight bearing exercises group, weight bearing exercises group |
| Transcutaneous electrical nerve stimulationAlso: TENSit is one of the electrical stimulation modalities which is used to relief pain, each patient receive it on both knees every session. | Combination product | non-weight bearing exercises group, weight bearing exercises group |
| weight bearing strengthening exercisesstrengthening exercises for quadriceps, gluteus maximus, gluteus Medius and calf muscle in the form of weight bearing from standing position each exercise was repeated for 10 times with 5 seconds hold in the same set and patient perform three sets in the same session for both lower limbs. | Combination product | weight bearing exercises group |
| Non-weight bearing strengthening exercisesstrengthening exercises for quadriceps, gluteus maximus, gluteus Medius and calf muscle in the form of non-weight bearing from lying and setting positions each exercise was repeated for 10 times with 5 seconds hold in the same set and patient perform three sets in the same session for both lower limbs. | Combination product | non-weight bearing exercises group |
Primary outcome
change happened in the dynamic balance from the baseline
Time frame: one day after the end of treatment
Biodex Balance System which is a device used to measure the balance of a person who stand on the platform of the device that give a measurement called over all stability index where 0 score means the best balance and the largest number indicate bad balance.
2 secondary outcomes
change happened in pain from the baseline
Time frame: one day after the end of treatment
change happened in the joint angle repositioning from baseline
Time frame: one day after the end of treatment
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 12 Jul 2023.
- Individual participant dataSharing planned: No
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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 stretching exercises, Transcutaneous electrical nerve stimulation and weight bearing strengthening 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 6 inclusion and 6 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 12 Jul 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?
change happened in the dynamic balance from the baseline (time frame: one day after the end of treatment). 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 12 Jul 2023.