Biomechanics and Clinical Outcomes in Responders and Non-Responders

NCT ID: NCT06080763

Last Updated: 2024-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-05

Study Completion Date

2025-04-30

Brief Summary

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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

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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.

Conditions

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Osteoarthritis, Knee Arthroplasty, Replacement, Knee Physical Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-Responders

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%.

Physical Therapy Management

Intervention Type PROCEDURE

Physical therapy management is a routine intervention provided by physical therapists at Mahidol University's Physical Therapy Center for individuals with knee osteoarthritis.

Responders

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%.

Physical Therapy Management

Intervention Type PROCEDURE

Physical therapy management is a routine intervention provided by physical therapists at Mahidol University's Physical Therapy Center for individuals with knee osteoarthritis.

Interventions

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Physical Therapy Management

Physical therapy management is a routine intervention provided by physical therapists at Mahidol University's Physical Therapy Center for individuals with knee osteoarthritis.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Komsak Sinsurin

Asst.Prof.Dr. Komsak Sinsurin

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Komsak Sinsurin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Biomechanics and Sports Research unit, Faculty of Physical Therapy, Mahidol University

Phunsuk Kantha, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Faculty of Physical Therapy, Mahidol University

Locations

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Physical Therapy Center, Mahidol University

Bangkok, Bang Phlat, Thailand

Site Status RECRUITING

Faculty of Physical Therapy, Mahidol University

Nakhon Pathom, Salaya, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Komsak Sinsurin, Ph.D.

Role: CONTACT

+66 024415450 ext. 20605

Facility Contacts

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Komsak Sinsurin, Ph.D.

Role: primary

+66 024415450 ext. 20605

Phunsuk Kantha, Ph.D.

Role: backup

+66 0932951646

Komsak Sinsurin, Ph.D.

Role: primary

+66 024415450 ext. 20605

Phunsuk Kantha, Ph.D.

Role: backup

+66 0932951646

Other Identifiers

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MU-CIRB 2023/117.1108

Identifier Type: -

Identifier Source: org_study_id

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