Mechanical Traction Force and Knee Joint Space

NCT05699733 | Completed

• 1 other identifier: H-2022-403
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

the purposes of this crossover study are to Purpose

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

Conditions

Knee Arthritis

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (4)

• hamstrings flexibility

  immediate (after first session)

• hamstrings flexibility

  short term (30 minutes after the first session)

• knee active range of motion

  immediate (after first session)

• knee active range of motion

  short term (30 minutes after the first session)

Study Arms (3)

Mechanical traction force 30% of body weight

EXPERIMENTAL

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

Device: mechanical traction for knee joint

Mechanical traction force 20% of body weight

EXPERIMENTAL

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

Device: mechanical traction for knee joint

Mechanical traction force 10% of body weight

EXPERIMENTAL

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

Device: mechanical traction for knee joint

Interventions

mechanical traction for knee joint DEVICE

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

Mechanical traction force 10% of body weight; Mechanical traction force 20% of body weight; Mechanical traction force 30% of body weight

Eligibility Criteria

• Age: 17 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy subject
• males or females
• No previous surgery in lower limbs

You may not qualify if:

• Diseased knee joint
• Knee osteoarthritis
• Any musculoskeletal problem in the lower extremities
• Varicose veins
• Pregnancy

Sponsors & Collaborators

• University of Hail: lead

Study Sites (1)

University of Hail

Hail, 3994, Saudi Arabia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: 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

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: January 26, 2023
• Study Start: March 1, 2023
• Primary Completion: July 22, 2023
• Study Completion: July 22, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1 year

Locations

SA (1)