Knee OsteoarthritisNCT06233175
Combined Kinetic Chain Exercises on Knee Osteoarthritis
A study testing combined kinetic chain exercises and conventional in people with Knee Osteoarthritis, run by Cairo University at 1 site in Egypt.
Trial summary
study will be conducted at faculty of physical therapy cairo university to investigate the effect of combined kinetic chain exercises on static and dynamic hamstring and quadriceps strength in knee osteoarthritis patients Read more about this study
- Who is it for?
- Ages 38 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- combined kinetic chain exercises and conventional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2024to 30 Apr 2024
- 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 38 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the patients age from38 to 65
- recent radiographs confirming grade 2 and 3 (mild to moderate ) osteoarthritis
- primary and secondary Osteoarthritis
- both gender
- unilateral knee osteoarthritis
- pain in the knee for most days of prior month
- morning stiffness less than 30 min. in duration
- patient body mass index (BMI) between 18.5 and 29.9 kg/m2
Who cannot join
- neurological disorders
- wheelchair bound
- significant cognitive impairment
- present systemic inflammatory arthritis
- history of hip and knee arthroplasty
- history of trauma or surgical arthroscopy of either knee in the last 6 months
- received knee intra-articular injection within the last 3 months
- under anticoagulant therapy ,recent or imminent surgery (within 3 months)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy
Cairo
hadeer a el sayaad, bachelor's
About this study
Official title: Combined Open And Closed Kinetic Chain Exercises On Static And Dynamic Strength Of Hamstring And Quadriceps In Knee Osteoarthritis Patients
study will be conducted at faculty of physical therapy cairo university to investigate the effect of combined kinetic chain exercises on static and dynamic hamstring and quadriceps strength in knee osteoarthritis patients
Read the detailed description
the study will be conducted at faculty of physical therapy cairo university to investigate the effect of combined kinetic chain exercises on static and dynamic hamstring and quadriceps strength ,knee pain ,function ,H/Q ratio in knee osteoarthritis patients .using lafayette hand held dynamometer to measuring static strength of hamstring and quadriceps ,and free weight by Brzycki formula for measuring dynamic hamstring and quadriceps strength by determining 1 repetition maximum ,and pain measured by visual analogue scale (VAS) rating from (0 = no pain ) to (10= worst pain ) ,and function by Western Ontario and McMaster Universities Osteoarthritis Index questionnaire lower score indicate patient get better ,number of patients will be 34 divided into 2 groups ,each group will include 17 patient ,with 2 drop out according to sample size calculation ,each group will receive conventional tens for 20 min. and hot back for 15 min. and stretching exercises for hamstring,quadriceps,calf muscles ,while the experimental group will be increased by combined kinetic chain exercises
- Conditions
- Knee Osteoarthritis
- Being tested
- combined kinetic chain exercises, conventional
- Keywords
- static knee strength,, dynamic knee strength, combined kinetic chain exercises, osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined kinetic chain exercisesOther
Also called experimental
combined kinetic chain exercises in form of wall slide ,terminal knee extension ,forward step up and down ,side step up and down ,straight leg raise ,seated knee extension ,stretching exercises , hot back and trans cutaneous electrical stimulation,
conventionalOther
Also called control
stretching exercises and hot back and trans cutaneous electrical stimulation,with out combined kinetic chain exercises
| Study group | Role | What they receive |
|---|---|---|
| conventional group | Active comparator | patients take conventional trans cutaneous electrical stimulation (tens) with a frequency of 100 Hz , a pulse duration of 60 micro seconds for 20 min. ,hot backs for 15 min,stretching exercises for hamstring ,quadriceps ,calf muscles Receives: Other: conventional |
| interventional group | Experimental | patients take conventional tens with a frequency of 100 Hz , a pulse duration of 60 micro seconds for 20 min. ,hot backs for 15 min,stretching exercises for hamstring ,quadriceps ,calf muscles with combined kinetic chain exercises (terminal knee extension,semi squat (wall slide) ,foreword step up and down ,straight leg raise ,seated knee extension ) Receives: Other: combined kinetic chain exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
static quadriceps strength
measuring static quadriceps from sitting position at angle 60 and 90
Measured: Evaluation will be performed prior to the first treatment session ;as a baseline measure,and at last treatment session (after 4 weeks) as a post -treatment measure
static hamstring strength
measuring static hamstring strength from sitting position at angle 60 and 90
Measured: Evaluation will be performed prior to the first treatment session ;as a baseline measure,and at last treatment session (after 4 weeks) as a post -treatment measure
dynamic quadriceps strength
measuring dynamic quadriceps strength from sitting position by randomised free weight and Brzycki formula
Measured: Evaluation will be performed prior to the first treatment session ;as a baseline measure,and at last treatment session (after 4 weeks) as a post -treatment measure
dynamic hamstring strength
measuring dynamic hamstring strength from prone position by randomised free weight and Brzycki formula
Measured: Evaluation will be performed prior to the first treatment session ;as a baseline measure,and at last treatment session (after 4 weeks) as a post -treatment measure
Hamstring /Quadriceps ((H/Q) ratio
dividing static hamstring on static quadriceps strength and dynamic hamstring on dynamic quadriceps strength
Measured: Evaluation will be performed prior to the first treatment session ;as a baseline measure,and at last treatment session (after 4 weeks) as a post -treatment measure
Secondary outcomes (2)
change in neck pain
by Visual Analog Scale (VAS) , (0=no pain ) and (10=worst pain)
Measured: Evaluation will be performed prior to the first treatment session ;as a baseline measure,and at last treatment session (after 4 weeks) as a post -treatment measure
function
BYWestern Ontario and McMaster Universities Osteoarthritis Index questionnaire ,Lower score indicate patient gets better
Measured: Evaluation will be performed prior to the first treatment session ;as a baseline measure,and at last treatment session (after 4 weeks) as a post -treatment measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start30 Jan 2024
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hadeer Ali El sayaad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233175
- Sponsor's protocol ID
- P.T.REC/012/004731
- Status last verified
- Jan 2024
- First submitted
- 20 Jan 2024
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Open And Closed Kinetic Chain Exercises On Static And Dynamic Strength Of Hamstring And Quadriceps In Knee Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT06233175
- Acronym / sponsor ID
- P.T.REC/012/004731
- Conditions
- Knee Osteoarthritis
- Keywords
- static knee strength,, dynamic knee strength, combined kinetic chain exercises, osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 31 Jan 2024 (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.
study will be conducted at faculty of physical therapy cairo university to investigate the effect of combined kinetic chain exercises on static and dynamic hamstring and quadriceps strength in knee osteoarthritis patients
Detailed description
the study will be conducted at faculty of physical therapy cairo university to investigate the effect of combined kinetic chain exercises on static and dynamic hamstring and quadriceps strength ,knee pain ,function ,H/Q ratio in knee osteoarthritis patients .using lafayette hand held dynamometer to measuring static strength of hamstring and quadriceps ,and free weight by Brzycki formula for measuring dynamic hamstring and quadriceps strength by determining 1 repetition maximum ,and pain measured by visual analogue scale (VAS) rating from (0 = no pain ) to (10= worst pain ) ,and function by Western Ontario and McMaster Universities Osteoarthritis Index questionnaire lower score indicate patient get better ,number of patients will be 34 divided into 2 groups ,each group will include 17 patient ,with 2 drop out according to sample size calculation ,each group will receive conventional tens for 20 min. and hot back for 15 min. and stretching exercises for hamstring,quadriceps,calf muscles ,while the experimental group will be increased by combined kinetic chain exercises
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional group | Active comparator | Other: conventionalpatients take conventional trans cutaneous electrical stimulation (tens) with a frequency of 100 Hz , a pulse duration of 60 micro seconds for 20 min. ,hot backs for 15 min,stretching exercises for hamstring ,quadriceps ,calf muscles |
| interventional group | Experimental | Other: combined kinetic chain exercisespatients take conventional tens with a frequency of 100 Hz , a pulse duration of 60 micro seconds for 20 min. ,hot backs for 15 min,stretching exercises for hamstring ,quadriceps ,calf muscles with combined kinetic chain exercises (terminal knee extension,semi squat (wall slide) ,foreword step up and down ,straight leg raise ,seated knee extension ) |
Who may qualify
- Ages
- 38 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- the patients age from38 to 65
- recent radiographs confirming grade 2 and 3 (mild to moderate ) osteoarthritis
- primary and secondary Osteoarthritis
- both gender
- unilateral knee osteoarthritis
Key exclusion criteria (8 listed)
- neurological disorders
- wheelchair bound
- significant cognitive impairment
- present systemic inflammatory arthritis
- history of hip and knee arthroplasty
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 |
|---|---|---|
| combined kinetic chain exercisesAlso: experimentalcombined kinetic chain exercises in form of wall slide ,terminal knee extension ,forward step up and down ,side step up and down ,straight leg raise ,seated knee extension ,stretching exercises , hot back and trans cutaneous electrical stimulation, | Other | interventional group |
| conventionalAlso: controlstretching exercises and hot back and trans cutaneous electrical stimulation,with out combined kinetic chain exercises | Other | conventional group |
Primary outcome
static quadriceps strength
Time frame: Evaluation will be performed prior to the first treatment session ;as a baseline measure,and at last treatment session (after 4 weeks) as a post -treatment measure
measuring static quadriceps from sitting position at angle 60 and 90
static hamstring strength
Time frame: Evaluation will be performed prior to the first treatment session ;as a baseline measure,and at last treatment session (after 4 weeks) as a post -treatment measure
measuring static hamstring strength from sitting position at angle 60 and 90
dynamic quadriceps strength
Time frame: Evaluation will be performed prior to the first treatment session ;as a baseline measure,and at last treatment session (after 4 weeks) as a post -treatment measure
measuring dynamic quadriceps strength from sitting position by randomised free weight and Brzycki formula
dynamic hamstring strength
Time frame: Evaluation will be performed prior to the first treatment session ;as a baseline measure,and at last treatment session (after 4 weeks) as a post -treatment measure
measuring dynamic hamstring strength from prone position by randomised free weight and Brzycki formula
Hamstring /Quadriceps ((H/Q) ratio
Time frame: Evaluation will be performed prior to the first treatment session ;as a baseline measure,and at last treatment session (after 4 weeks) as a post -treatment measure
dividing static hamstring on static quadriceps strength and dynamic hamstring on dynamic quadriceps strength
2 secondary outcomes
change in neck pain
Time frame: Evaluation will be performed prior to the first treatment session ;as a baseline measure,and at last treatment session (after 4 weeks) as a post -treatment measure
function
Time frame: Evaluation will be performed prior to the first treatment session ;as a baseline measure,and at last treatment session (after 4 weeks) as a post -treatment measure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined kinetic chain exercises and conventional 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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 31 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hadeer a el sayaad (01064125662, hadirelsayaad95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
static quadriceps strength (time frame: Evaluation will be performed prior to the first treatment session ;as a baseline measure,and at last treatment session (after 4 weeks) as a post -treatment measure). The study lists 5 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 31 Jan 2024.