Effect of Antigravity Treadmill in Knee Osteoarthritis (AGTreadmill)

Knee Osteoarthritis Clinical Trial

— AGTreadmill  

Official title:

Effect of Antigravity Treadmill Training on Pain, Gait Characteristics, and Function in Patients With Knee Osteoarthritis- A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06347692
• Other study ID #: SCBR-240/2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 7, 2024
• Est. completion date: April 20, 2025

Study information

• Verified date: April 2024
• Source: Prince Sattam Bin Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To date, the anti-gravity treadmill, as a representative method of lower body positive pressure treadmills, has been rarely reported for knee osteoarthritis rehabilitation.

Purpose: This study aims to evaluate the effect of antigravity treadmill training on pain, gait characteristics, and function in patients with knee osteoarthritis.

Description:

The study included 40 patients with knee osteoarthritis who were randomly assigned to one of two groups: the antigravity treadmill group (n=20) or the control group (n=20 ). For 12 weeks, the antigravity treadmill group received training on the Alter G treadmill (75% weight-bearing, 30 minutes per session, three times per week) combined with traditional physical therapy. During the same period, the control group received only traditional physical therapy. The Visual Analogue Scale, Walkway System, and the Western Ontario and McMaster Universities Arthritis Index were used to assess pain, spatiotemporal gait parameters, and patient function, respectively. All outcome measures were obtained pretreatment, post-treatment, and 3 months follow-up assessment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 20, 2025
• Est. primary completion date: April 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients should: (1) be =50 years old

• Patients have been diagnosed with mild to moderate osteoarthritis by a physician and confirmed by radiograph imaging (Kellgren & Lawrence grade 1-3)

• Patients complain of knee pain during the past 30 days when walking, squatting, and/or kneeling (the minimum level 3/10 on visual analogue scale before inclusion)

• Patients' body mass index greater than 30.

Exclusion criteria

• Patients were excluded if they have a history of ankle, knee, or hip injury or medical operation

• Have used knee injection for their knee osteoarthritis pain within the past year

• Have a history of other medical conditions that would interfere with walking

• Received physical therapy during the past 3 months for knee osteoarthritis

• Had any metabolic, pulmonary, neuromuscular, neurological, and/or autoimmune disease.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• antigravity treadmill
An Alter G treadmill (Alter G Pro 200, Alter G Inc, USA) was used to provide training to the patients in the antigravity treadmill group. The Alter G allows the patient to change their body weight from 20% to 100% in 1% increments. The air pressure inside the lower body positive pressure chamber can be adjusted from 0 to 2.0 kilopascal above atmospheric pressure. They are very comfortable to train in for long periods of time and have simple controls for adjusting body weight, speed, and inclination.
• physical therapy exercise program
Both groups received the same traditional physical therapy program for 12 weeks, three times a week, for 30 min each. The conventional physical therapy treatment consisted of acupuncture transcutaneous electrical nerve stimulation, Hot moist pack, Ultrasound and quadriceps setting

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prince Sattam Bin Abdulaziz University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of patient pain	The visual analogue scale is a reliable, valid, responsive, and frequently used pain outcome measure. It consists of a bidirectional 10 cm straight line with two labels, that is, "no pain" and "worst possible pain", located at either end of the line. Patients are instructed to draw a vertical mark on the line indicating their pain level.	Pre and post 3 months intervention period
Primary	Evaluation of gait parameters (step length)	Gait parameters were measured using walkway System. The researcher assessed step length in centimeters	Pre and post 3 months intervention period
Primary	Evaluation of gait parameters (step time)	Gait parameters were measured using walkway System. The researcher assessed step time in seconds	Pre and post 3 months intervention period
Primary	Evaluation of gait parameters (velocity)	Gait parameters were measured using walkway System. The researcher assessed velocity which is measured in centimeter/second	Pre and post 3 months intervention period
Primary	Evaluation of patient function	The Western Ontario and McMaster Universities Arthritis Index was used for assessing activities of daily living, functional mobility, gait, general health, and quality of life in patients with knee osteoarthritis. It has a total of 24 items and three subscales, namely pain (5 items), stiffness (2 items), and function (17 items), scored on a five-point ordinal scale, 0 - none, 1 - mild, 2 - moderate, 3 - severe, and 4 - extremely severe. Higher scores indicate worse pain, stiffness, and functional limitations.	Pre and post 3 months intervention period