Effect of Antigravity Treadmill in Knee Osteoarthritis (AGTreadmill)

NCT06347692 | Not Yet Recruiting

• 1 other identifier: SCBR-240/2024
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Osteoarthritis

Keywords

antigravity treadmill; osteoarthritis; gait characteristics; patient function

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

control group

EXPERIMENTAL

The control group received a conventional physical therapy program.

Other: physical therapy exercise program

study group

EXPERIMENTAL

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

Interventions

antigravity treadmill OTHER

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.

study group

physical therapy exercise program OTHER

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

control group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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' body mass index greater than 30.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prince Sattam Bin Abdulaziz University: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients were randomly assigned to either the antigravity treadmill group (n = 20) or the control group (n = 20 ) using an online randomization website (www.randomization.com). The control group received a conventional physical therapy program. The therapists responsible for measuring and assessing the outcomes remained blinded to the group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: April 4, 2024
• Study Start: April 7, 2024
• Primary Completion: April 20, 2024
• Study Completion: April 20, 2025
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share