Clinical trial NCT06347692: Effect of Antigravity Treadmill in Knee Osteoarthritis (AGTreadmill)
Official title: Effect of Antigravity Treadmill Training on Pain, Gait Characteristics, and Function in Patients With Knee Osteoarthritis- A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: antigravity treadmill
osteoarthritis
gait characteristics
patient function
Lead sponsor: Prince Sattam Bin Abdulaziz University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of patient pain
timeFrame: Pre and post 3 months intervention period
measure: Evaluation of gait parameters (step length)
timeFrame: Pre and post 3 months intervention period
measure: Evaluation of gait parameters (step time)
timeFrame: Pre and post 3 months intervention period
measure: Evaluation of gait parameters (velocity)
timeFrame: Pre and post 3 months intervention period
measure: Evaluation of patient function
timeFrame: Pre and post 3 months intervention period
Secondary outcomes:
Other outcomes:
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