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Effects of a Modified Walker With and Without Physical Therapy on Clinical Outcomes and Cartilage Metabolism Biomarkers in Community-Dwelling Adults With Knee Osteoarthritis: A Randomized Controlled Trial

The study of biological markers and innovative assessment kits for monitoring osteoarthritis joints in community-based patient care

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250528002
Enrollment
63
Registered
2025-05-28
Start date
2025-05-30
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

knee osteoarthritis knee osteoarthritis walker physiotherapy

Interventions

KOA participants recieve standard physiotherapy by professional Physical therapy for 12 weeks.,KOA participants using a modified walker in daily activities for 12 weeks.,KOA patients no treament for 1
Experimental Other,Active Comparator Device,Active Comparator No treatment
Physiotherapy combined with modified walker for KOA patient,modified walker for KOA patient,KOA patient control

Sponsors

Research Grant of Burapha University through National Research Council of Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male or female participants aged over 50 years. 2. Clinical diagnosis of knee osteoarthritis based on the American College of Rheumatology (ACR) criteria, as outlined by Heidari B. (2011) in Caspian Journal of Internal Medicine. 3. Ability to ambulate independently or with the use of an assistive device. 4. No history of receiving physical therapy or structured knee osteoarthritis education within the 3 months prior to enrollment in the study. 5. Willingness and ability to comply with the assigned intervention schedule if randomized into a treatment group.

Exclusion criteria

Exclusion criteria: Exclusion Criteria Prior diagnosis of rheumatoid arthritis or gout. Inability to communicate or participate in physical assessments. Uncorrectable visual impairments (e.g., advanced cataracts or diabetic retinopathy). 1. Uncontrolled hypertension at the time of screening. 2. Known allergy to surface electromyography (sEMG) electrode adhesives. 3. High risk for exercise participation, defined as: 4. Classified as high risk based on the American College of Sports 1) Medicine (ACSM) pre-participation screening. 2) Moderate cardiovascular risk (score >2 on CVD Risk Factor Assessment), with physician judgment deeming the participant unsuitable for the study's physical testing.

Design outcomes

Primary

MeasureTime frame
Biomarker Before and 12 weeks after intervention Serum Biomarker,Ultrasound imaging Before and 12 weeks after intervention lower extremity muscle morphology,calf circumference Before and 12 weeks after intervention calf circumference,Knee Outcome Score Before and 12 weeks after intervention Knee Osteoarthritis Outcome Score (KOOS),pain score Before and 12 weeks after intervention visual analogue score for pain ,Kinesiophobia Before and 12 weeks after intervention Tampa Scale for Kinesiophobia,Falls Efficacy Scale Before and 12 weeks after intervention Falls Efficacy Scale,stress Before and 12 weeks after intervention Thai version of 10-Item Perceived Stress Scale-10,Physical activity Before and 12 weeks after intervention Global Physical Activity Questionnaire: GPAQ,sarcopenia screening Before and 12 weeks after intervention Strength, assistance with walking, rising from a chair, climbing stairs, and falls (SARC-F) questionnaire,body composition Before and 12 weeks after intervention inbody,muscle activation Before and 12 weeks after intervention surface Electromyography (EMG),knee extension-flexion strength Before and 12 weeks after intervention Biodex sytem 4Pro,hand grip strength Before and 12 weeks after intervention Hand-grip dynamometer,gait speed Before and 12 weeks after intervention 10 meter walk test ,knee score Before and 12 weeks after intervention Oxford knee score ,30 second Chair Test Before and 12 weeks after intervention 30 second Chair Test,40 meter fast paced walk test Before and 12 weeks after intervention 40 meter fast paced walk test,Stair climb test Before and 12 weeks after intervention Stair climb test

Secondary

MeasureTime frame
lower limbs range of motion Before and 12 weeks after intervention range of motion

Countries

Thailand

Contacts

Public ContactSIRIRAT KIATKULANUSORN

Burapha University, Thailand

siriratk@go.buu.ac.th038103166

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026