Home-based physical activity intelligent programme for patients with lower extremity Ilizarov: a study protocol for a randomised controlled trial.

Lower extremity Ilizarov surgery is associated with reduced physical activity and functional decline, and standardised intelligent rehabilitation programmes for this population are lacking.

• Lower extremity Ilizarov surgery is described as 'a common procedure for correcting bone deformities'
• The home-based PA intelligent programme (HB-PAIP) 'has shown promise in improving postoperative outcomes'
• The authors note that 'standardised, intelligent programmes specifically designed for patients undergoing lower extremity Ilizarov surgery are lacking'

The trial will enrol 166 participants randomised 1:1 to either the HB-PAIP group or a control group receiving traditional care.

• A total of 166 participants aged ≥18 years who have undergone lower extremity Ilizarov surgery will be included
• Participants will be randomly allocated to either the HB-PAIP group or control group (CG) at a 1:1 ratio
• The HB-PAIP group will receive a '6-month, structured and algorithm-guided home rehabilitation programme via an intelligent motion rehabilitation management system'
• The control group will receive traditional care

The primary outcome of the trial is functional mobility assessed by the Timed Up-and-Go test, measured at baseline, 3 months, and 6 months.

• Assessments will be conducted at three time points: baseline, 3 months (mid-intervention), and 6 months (post-intervention)
• The Timed Up-and-Go test serves as the primary outcome measure for functional mobility
• The intervention duration is 6 months

The trial includes multiple secondary outcomes spanning physical function, pain, mental health, and nutritional status.

• Physical function secondary outcomes include the 10-metre walking test and passive ankle range of motion
• Functional status will be assessed using the Activity of Daily Living score
• Pain will be measured using the Visual Analogue Scale score
• Mental health will be assessed using the Hamilton Anxiety and Hamilton Depression Scales
• Nutritional biomarkers including serum levels of haemoglobin and albumin will also be measured

The study received initial ethics approval in January 2024, with a protocol amendment approved in January 2026, and has been registered in the Chinese Clinical Trial Registry.

• Initially approved by the Human Ethics Review Board of the Second Affiliated Hospital of Zhejiang University School of Medicine on 26 January 2024 (approval number: 20240139)
• Protocol amendment was approved on 28 January 2026 (approval number: 20260134)
• The trial is registered under ChiCTR2400093880
• Results will be disseminated through peer-reviewed publications and presentations at relevant scientific conferences