Combined Kinetic Chain Exercises on Knee Osteoarthritis

January 29, 2024 updated by: hadeer Ali El sayaad, Cairo University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Faculty of Physical Therapy
        • Contact:
          • hadeer a el sayaad, bachelor's

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: conventional group
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
Other: conventional
stretching exercises and hot back and trans cutaneous electrical stimulation,with out combined kinetic chain exercises
Other Names:
  • control
Experimental: interventional group
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 )
Other: combined kinetic chain exercises
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,
Other Names:
  • experimental

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
by Visual Analog Scale (VAS) , (0=no pain ) and (10=worst pain)
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
BYWestern Ontario and McMaster Universities Osteoarthritis Index questionnaire ,Lower score indicate patient gets better
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P.T.REC/012/004731

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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