Effect of Antigravity Treadmill in Knee Osteoarthritis (AGTreadmill) (AGTreadmill)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: physical therapy exercise program; Other: antigravity treadmill

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: control group; The control group received a conventional physical therapy program.	Other: 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
Experimental: study group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Prince Sattam Bin Abdulaziz University

Study record dates

Study Major Dates

• Study Start (Estimated): April 7, 2024
• Primary Completion (Estimated): April 20, 2024
• Study Completion (Estimated): April 20, 2025

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: osteoarthritis; antigravity treadmill; gait characteristics; patient function
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: SCBR-240/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No