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

bmjopen · 2026-03-11 · canonical JSON source

5 visible annotations · policy: published · automated confidence ≥ 75.00%

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Introduction Lower extremity Ilizarov surgery, a common procedure for correcting bone deformities, is often associated with reduced physical activity (PA) and functional decline. The home-based PA intelligent programme (HB-PAIP) has shown promise in improving postoperative outcomes. However, standardised, intelligent programmes specifically designed for patients undergoing lower extremity Ilizarov surgery are lacking. This study aims to evaluate the effects of a 6-month home-based intelligent interaction programme on PA levels and to assess its impact on mental health, self-efficacy and quality of life among patients with lower extremity Ilizarov.Methods and analysis A total of 166 participants aged ≥18 years who have undergone lower extremity Ilizarov surgery 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, whereas CG will receive traditional care. The assessments will be conducted at baseline, 3 months (mid-intervention) and 6 months (post-intervention). The primary outcome is functional mobility assessed by the Timed Up-and-Go test. Secondary outcomes include the 10-metre walking test, the passive ankle range of motion, the Activity of Daily Living score, the Visual Analogue Scale score, the mental status measured using the Hamilton Anxiety and Hamilton Depression Scales and serum levels of haemoglobin and albumin.Ethics and dissemination This study was 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). The protocol amendment was approved on 28 January 2026 (approval number: 20260134). Results will be disseminated through peer-reviewed publications and presentations at relevant scientific conferences.Trial registration number ChiCTR2400093880.