Effect of Antigravity Treadmill in Knee Osteoarthritis (AGTreadmill)

Not Applicable

Not yet recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Other: physical therapy exercise program; Other: antigravity treadmill

• Registration Number: NCT06347692
• Lead Sponsor: Prince Sattam Bin Abdulaziz University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-02-27
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-02
• Last Update Submitted: 2024-04-02
• Study First Posted: 2024-04-04
• Last Update Posted: 2024-04-04
• Study Start: 2024-04-07
• Primary Completion: 2024-04-20
• Study Completion: 2025-04-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	physical therapy exercise program	The control group received a conventional physical therapy program.
study group	antigravity treadmill	Conversely, in addition to the conventional physical therapy program provided to the control group, the antigravity treadmill group underwent antigravity treadmill training using the Alter G device.

Primary Outcome Measures

Name	Time	Method
Assessment of patient pain	Pre and post 3 months intervention period	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.
Evaluation of gait parameters (step length)	Pre and post 3 months intervention period	Gait parameters were measured using walkway System. The researcher assessed step length in centimeters
Evaluation of gait parameters (velocity)	Pre and post 3 months intervention period	Gait parameters were measured using walkway System. The researcher assessed velocity which is measured in centimeter/second
Evaluation of patient function	Pre and post 3 months intervention period	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.
Evaluation of gait parameters (step time)	Pre and post 3 months intervention period	Gait parameters were measured using walkway System. The researcher assessed step time in seconds