Biomechanics and Clinical Outcomes in Responders and Non-Responders

Mahidol University

Status: Enrolling

Conditions: Arthroplasty, Replacement, Knee; Physical Therapy; Osteoarthritis, Knee

Treatments: Procedure: Physical Therapy Management

Study type: Observational

Funder types: Other

Identifiers

NCT06080763

MU-CIRB 2023/117.1108

Details and patient eligibility

About

Knee osteoarthritis is a degenerative joint disease that affects many older adults. However, not all patients see improvements as a result of physical therapy management; therefore, a better understanding of biomechanics and assessment of clinical outcomes between responders and non-responders is required.

The included participants will be provided with informed consent and an explanation of the study procedure before enrolling in data collection. The data collection will be arranged in the same order. Practice trials will be provided before the start of data collection. The data collection will consist of standardized questionnaires, assessments, and tests commonly used in clinics.

Full description

During data collection, markerless motion capture systems will be placed around the area of interest. The markerless system does not require markers to be attached to the participant's body.

The data collection will include:

1. Demographic information such as age, sex, body height, body weight, body mass index, medical history, medical diagnosis, and the Kellgren-Lawrence score.
2. Patient-reported questionnaires such as the numeric pain rating scale, knee injury and osteoarthritis outcome score, Western Ontario and McMaster Universities Osteoarthritis, and Depression, Anxiety, and Stress Scale - 21 Items.
3. Clinical assessments such as the Varus-valgus laxity test, Foot posture index, Range of motion, Muscle flexibility, and Muscle strength.
4. Functional tests such as the Timed up and go test, Five times sit-to-stand test, Four-meter walk test, and Bipedal quiet stance test.

Enrollment: 80 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of knee osteoarthritis based on American College of Rheumatology
• Pain intensity of ≥ 4 out of 10 at the pre-treatment day
• Ability to walk for at least six meters without an assistive device

Exclusion criteria

• History of previous lower limb surgery, such as total hip replacement
• History of neurological disorder, such as stroke
• History of vestibular disease, such as Meniere's disease

Trial design

80 participants in 2 patient groups

Non-Responders

Description:

Individuals who do not respond to physical therapy are determined by the absence of significant improvements, with no change in pain or function exceeding 50%, and with an absolute change of less than 20%.

Treatment:

Procedure: Physical Therapy Management

Responders

Description:

Individuals who respond to physical therapy are determined by the presence of significant improvements, with changes in pain or function exceeding 50%, and with an absolute change of more than 20%.

Treatment:

Procedure: Physical Therapy Management