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Clinical Effectiveness of Wearable Accelerated Rehabilitation Robots for Knee Osteoarthritis in the Elderly: A Multicenter, Prospective, Randomized, Controlled Clinical Trial

Clinical Effectiveness of Wearable Accelerated Rehabilitation Robots for Knee Osteoarthritis in the Elderly: A Multicenter, Prospective, Randomized, Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110723
Enrollment
Unknown
Registered
2025-10-20
Start date
2025-10-20
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Elderly Patients with Knee Osteoarthritis

Interventions

Wearable Accelerated Recovery Robot (WARR) group:The intervention group will receive rehabilitation treatment using WARR, 30 minutes per day, 3 times per week, for 4 weeks.
Control group:The control group will receive traditional rehabilitation therapy, 30 minutes per day, 3 times per week, for 4 weeks.

Sponsors

The Fourth Medical Center of the General Hospital of the People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 55 years old, gender not restricted; 2. Height: 150-190cm, thigh length: 35-55cm, calf length: 30-55cm; 3. Diagnosed as knee osteoarthritis (KOA) according to the standards of "Chinese Guidelines for Diagnosis and Management of Osteoarthritis (2021 Edition)"; 4. Patients who have undergone unilateral knee arthroplasty or total knee arthroplasty (TKA); 5. Adequate cognitive function and compliance to complete all assessments and therapeutic interventions; 6. Voluntary participation and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Lower limb key muscle groups strength <= Grade 2; 2. History of previous lower limb orthopedic surgery; 3. Concomitant neurological or muscular disorders; 4. Severe systemic medical conditions precluding participation in training; 5. Deep vein thrombosis (DVT) or active thrombosis in the lower limbs; 6. Severe knee malalignment or instability; 7. Allergy to study device materials; 8. Other conditions deemed unsuitable for participation by the investigator.

Design outcomes

Primary

MeasureTime frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC);

Secondary

MeasureTime frame
Gait analysis;The strength of knee flexion and extension;Active and passive range of motion of the knee joint;Timed Up and Go Test ?(TUG);visual analogue scale (VAS);Instrumental activities of daily living (IADL);Self-rating depression scale (SDS);The 36-Item Short Form Health Survey;Berg Balance Scale (BBS);Morse Fall Scale (MFS);Patient Satisfaction;

Countries

China

Contacts

Public ContactLi Xiao

Department of Rehabilitation Medicine, Department of Orthopaedic Medicine, Fourth Medical Center, General Hospital of the People's Liberation Army, China

lixiaoPLA@163.com+86 156 5234 9858

Outcome results

None listed

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