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Value of body-worn sensors to assess functioning in the follow-up of patients with a hip fracture

Added value of a technology-driven assessment of functioning in patients with proximal femoral fracture

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN21642113
Enrollment
65
Registered
2023-01-30
Start date
2021-05-21
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Surgical repair of proximal femur fractures in patients older than 50 years Surgery

Interventions

This study is a monocentric prospective study with an intervention (additional use of one sensor on the chest without health risk to the patient), with retrospective use of Good Clinical Practice (GCP

Sponsors

Universitair Ziekenhuis Leuven
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Surgical treatment of proximal femur fracture 2. Age >50 years 3. Immediate weight bearing allowed after surgery

Exclusion criteria

Exclusion criteria: 1. Revision surgery (affected leg) 2. Pathological fracture 3. Preoperative bedridden, not able to stand up 4. Current COVID-19 infection or other infectious risk requiring isolation 5. Polytrauma/multiple injuries

Design outcomes

Primary

MeasureTime frame
1. Patient-reported functional status assessed using the Harris Hip Score: Pre-surgery status at day 9 after surgery; week 6, and months 3 and 6 after surgery 2. Observed functional status assessed using DEMMI at Day 9, week 6, and months 3 and 6 after surgery 3. Performance-based functional status assessed using TUG test at Day 9, week 6, and months 3 and 6 after surgery 4. Physical activity assessed using activity sensors during hospitalisation, at least 7 days at home, week 6, and months 3 and 6 5. Health status assessed using Global ratings of perceived effect at week 6, and months 3 and 6

Secondary

MeasureTime frame
The following outcomes will be extracted from the patients' medical records or questioned to the patient during hospitalisation and at day 9, week 6, months 3 and 6 after the surgery: 1. Pre-surgery status assessed at day 9 after surgery 2. Demographics and anthropometrics 3. Medical history 4. Time of admission, surgery 5. Surgical procedure, history of hip surgery 6. Time to start mobilization and gait rehabilitation, number and timing of physical therapy sessions 7. Date of admission, medical discharge and discharge (calculation of admission time, admission time until medical discharge) 8. Mental status assessed using a categorical clinician score (electronic patient record), at all time points 9. Comorbidity assessed using the American Society for Anaesthesiologists Physical Status classification 10. Comorbidity assessed using the Charlson Comorbidity Index 11. Medication schedule 12. Fear of falling assessed using the Fall Efficacy Scale 13. Mortality 14. Pain assessed using Numerical Rating Scale 15. Participation assessed using the Parker Mobility Score 16. Feasibility of sensor measurements assessed using Numerical Rating Scale

Countries

Belgium

Contacts

Public ContactElga Nijs
elga.nijs@uzleuven.be+32 (0)1642364

Outcome results

None listed

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