Clinical trial NCT06080763: Biomechanics and Clinical Outcomes in Responders and Non-Responders
Official title: Exploring Biomechanics and Clinical Outcomes in Responders and Non-Responders to Physical Therapy Management for Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis, Knee
Arthroplasty, Replacement, Knee
Physical Therapy
Keywords: Biomechanics
Assessment, Outcomes
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with knee osteoarthritis who are currently receiving physical therapy management at Mahidol University's Physical Therapy Center

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity
timeFrame: Pain intensity will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: Knee injury and osteoarthritis outcome score will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
measure: Western Ontario and McMaster Universities Osteoarthritis
timeFrame: Western Ontario and McMaster Universities Osteoarthritis will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
measure: Depression, Anxiety and Stress Scale - 21 Items
timeFrame: Depression, Anxiety and Stress Scale - 21 Items will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
measure: Varus-valgus laxity score
timeFrame: Varus-valgus laxity score will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
measure: Foot posture index
timeFrame: Foot posture index will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
measure: Muscle flexibility
timeFrame: Muscle flexibility will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
measure: Range of motion
timeFrame: Range of motion will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
measure: Muscle strength
timeFrame: Muscle strength will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
measure: Joint kinematics
timeFrame: Joint kinematics will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Physical Therapy Center, Mahidol University
state: Bang Phlat
city: Nakhon Pathom
country: Thailand
facility: Faculty of Physical Therapy, Mahidol University
state: Salaya
Study officials:
affiliation: Biomechanics and Sports Research unit, Faculty of Physical Therapy, Mahidol University
name: Komsak Sinsurin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Physical Therapy, Mahidol University
name: Phunsuk Kantha, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: