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Mechanical Traction Force and Knee Joint Space

Primary Purpose

Knee Arthritis

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
mechanical traction for knee joint
Sponsored by
University of Hail
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Arthritis

Eligibility Criteria

17 Years - 55 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy subject males or females No previous surgery in lower limbs Exclusion Criteria: Diseased knee joint Knee osteoarthritis Any musculoskeletal problem in the lower extremities Varicose veins Pregnancy

Sites / Locations

  • University of Hail

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Mechanical traction force 30% of body weight

Mechanical traction force 20% of body weight

Mechanical traction force 10% of body weight

Arm Description

will receive continuous mechanical traction from semi flexed knee, for 30 minutes using 30% of the body weight as a traction force

will receive continuous mechanical traction from semi flexed knee, for 30 minutes using 20% of the body weight as a traction force

will receive continuous mechanical traction from semi flexed knee, for 30 minutes using 10 % of the body weight as a traction force

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
November 8, 2022
Last Updated
September 21, 2023
Sponsor
University of Hail
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1. Study Identification

Unique Protocol Identification Number
NCT05699733
Brief Title
Mechanical Traction Force and Knee Joint Space
Official Title
Influences of Mechanical Traction Using Different Forces on Knee Joint Space, Range of Motion, and Hamstring Flexibility in Asymptomatic Subjects: Preliminary Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
July 22, 2023 (Actual)
Study Completion Date
July 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Hail

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
the recruited sample will be subjected to 3 treatment conditions according to the traction force used. pre-post comparisons and between conditions comparisons will be conducted
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mechanical traction force 30% of body weight
Arm Type
Experimental
Arm Description
will receive continuous mechanical traction from semi flexed knee, for 30 minutes using 30% of the body weight as a traction force
Arm Title
Mechanical traction force 20% of body weight
Arm Type
Experimental
Arm Description
will receive continuous mechanical traction from semi flexed knee, for 30 minutes using 20% of the body weight as a traction force
Arm Title
Mechanical traction force 10% of body weight
Arm Type
Experimental
Arm Description
will receive continuous mechanical traction from semi flexed knee, for 30 minutes using 10 % of the body weight as a traction force
Intervention Type
Device
Intervention Name(s)
mechanical traction for knee joint
Intervention Description
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
Primary Outcome Measure Information:
Title
knee joint space
Description
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
Time Frame
immediate (after first session)
Title
knee joint space
Description
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
Time Frame
short term (30 minutes after the first session)
Secondary Outcome Measure Information:
Title
hamstrings flexibility
Description
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
Time Frame
immediate (after first session)
Title
hamstrings flexibility
Description
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
Time Frame
short term (30 minutes after the first session)
Title
knee active range of motion
Description
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
Time Frame
immediate (after first session)
Title
knee active range of motion
Description
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
Time Frame
short term (30 minutes after the first session)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy subject males or females No previous surgery in lower limbs Exclusion Criteria: Diseased knee joint Knee osteoarthritis Any musculoskeletal problem in the lower extremities Varicose veins Pregnancy
Facility Information:
Facility Name
University of Hail
City
Hail
ZIP/Postal Code
3994
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
it will available upon request from the principal investigator
IPD Sharing Time Frame
1 year

Learn more about this trial

Mechanical Traction Force and Knee Joint Space

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