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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05699733
Other study ID # H-2022-403
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date July 22, 2023

Study information

Verified date September 2023
Source University of Hail
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the purposes of this crossover study are to Purpose 1. To determine the most effective traction force for knee joint that can be used in the treatment of patients with KOA. 2. To determine the influence of knee joint traction on ROM ok knee joint flexion and extension 3. To determine the influence of knee joint traction on the flexibility of hamstring muscles


Description:

this study is a pilot study design aiming to determine the most effective mechanical traction force used for knee joint treatment. this effectiveness was assessed in favor of the separation of the joint surfaces in cm in addition to the hamstring flexibility measured in cm and active knee flexion range of motion. according to previous literature, there is no consensus regarding the most appropriate traction force that can produce statistical and clinically meaningful differences so we started this pilot study. the results of this study will be used to conduct a larger-scale study using the most appropriate traction force on patients having knee osteoarthritis.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date July 22, 2023
Est. primary completion date July 22, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years to 55 Years
Eligibility Inclusion Criteria: 1. Healthy subject 2. males or females 3. No previous surgery in lower limbs Exclusion Criteria: 1. Diseased knee joint 2. Knee osteoarthritis 3. Any musculoskeletal problem in the lower extremities 4. Varicose veins 5. Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
mechanical traction for knee joint
All participants will receive a single session per condition. This session will consist of continuous mechanical knee traction for 30 minutes while the participant assumes a supine position with the treated limb in semiflexion (30° of flexion). the treated limb will be supported using the traction bed's table that is used for this purpose. The knee position angle will be measured by a standard goniometer. Pelvis and thigh straps will be used to fix the body and prevent slippage during the application of the traction force. A customized leg cuff will be placed around the lower leg (above the ankle joint), and a traction rope will be extending horizontally from the cuff to the traction device. 48 hours of washing out will separate the sessions of different conditions

Locations

Country Name City State
Saudi Arabia University of Hail Hail

Sponsors (1)

Lead Sponsor Collaborator
University of Hail

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary knee joint space the distance in millimeters will be measured between the articilar acriliges of femur and tibia in non-weight bearing position from the medial and lateral aspects of the knee joint using ultrasonography device designed to assess musculoskeletal conditions immediate (after first session)
Primary knee joint space the distance in millimeters will be measured between the articilar acriliges of femur and tibia in non-weight bearing position from the medial and lateral aspects of the knee joint using ultrasonography device designed to assess musculoskeletal conditions short term (30 minutes after the first session)
Secondary hamstrings flexibility using the Sit and reach test: The Sit and reach test is one of the linear flexibility tests which helps to measure the extensibility of the hamstrings and lower back. it is also a field test which is easy to administer in a community setting with a large scale of population size immediate (after first session)
Secondary hamstrings flexibility using the Sit and reach test: The Sit and reach test is one of the linear flexibility tests which helps to measure the extensibility of the hamstrings and lower back. it is also a field test which is easy to administer in a community setting with a large scale of population size short term (30 minutes after the first session)
Secondary knee active range of motion Bubble inclinometer will be used to assess the active knee joint flexion range. Participant will assume supine position and after proper placement of the goniometer, she will be asked to bend her knee and hip joints as much as possible immediate (after first session)
Secondary knee active range of motion Bubble inclinometer will be used to assess the active knee joint flexion range. Participant will assume supine position and after proper placement of the goniometer, she will be asked to bend her knee and hip joints as much as possible short term (30 minutes after the first session)
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