Skip to content

Evaluation of the therapeutic effect of personalized orthopedic insole combined with gait training on knee osteoarthritis

Evaluation of the therapeutic effect of personalized orthopedic insole combined with gait training on knee osteoarthritis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035865
Enrollment
Unknown
Registered
2020-08-19
Start date
2020-11-24
Completion date
Unknown
Last updated
2020-08-24

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

Conditions

Knee osteoarthritis

Interventions

Experimental group:Orthopedic insole+Gait training
Control group:Ordinary insole +Daily gait

Sponsors

People's Hospital of Peking University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with NRs >= 4 in the past month; 2. Patients with unilateral Kellgren & Lawrence score >= 2; 3. The patients with medial compartment osteoarthritis showed by X-ray film at the loading position of knee joint, that is, according to the OARSI score standard, the osteophyte of medial compartment was >= 1 point, and the joint space of medial compartment was greater than or equal to 1 point and larger than that of lateral compartment; 4. Patients with varus or neutral position less than 0 degree were measured on the full length film of both lower limbs.

Exclusion criteria

Exclusion criteria: 1. The score of osteophyte or joint space in lateral compartment was higher than that in medial compartment; 2. The patients who have received hormone injection therapy through knee joint cavity in recent one month; 3. Patients with other types of arthritis (such as rheumatoid arthritis, crystalline arthritis, etc.); 4. Patients with osteoarthritis of both knees; 5. Patients who have undergone high tibial or fibular osteotomy, unicompartment or total knee arthroplasty; 6. Patients with scoliosis or pelvic tilt; 7. Patients with other complications that seriously affect physical function, such as cerebral infarction, lumbar lesions with surgical indications, lower extremity vascular diseases, etc; 8. Patients who have used wedge-shaped or other customized insoles, knee or ankle braces now or in the past 6 months; 9. Patients who need to use assistive tools when walking; 10. Obese patients (BMI >= 36 kg / m2); 11. Subjects with ankle OA; 12. Subjects with hip OA; 13. Subjects who refused to participate in the study after training in insole wearing and gait training.

Design outcomes

Primary

MeasureTime frame
Numeric Rating Scale;

Secondary

MeasureTime frame
Intermittent and Constant Osteoarthritis Pain;Changes of knee joint pain in 400m walking test;Knee Adduction Moment;Knee MOAKS score;Mechanical axis force line of knee jiont;Physical activity;

Countries

China

Contacts

Public ContactJianhao Lin

People's Hospital of Peking University

linjianhao@pkuph.edu.cn+86 13501004301

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026