Implementation of Partial Load through Instruction with Biofeedback Compared to the Standard Method
Descrizione riassuntiva dello studio
In orthopedics and traumatology, partial loading is a common treatment protocol following a surgical procedure, aimed at stimulating the affected structure (e.g., after an implant) while simultaneously avoiding overloading to prevent re-injury. The instruction regarding the permissible weight on the affected leg prescribed by the doctor is carried out by the physiotherapist. This is usually guided with a personal scale to demonstrate the permissible weight while standing. Implementing these guidelines in daily activities, such as walking or climbing stairs, often poses a significant challenge for patients. Measuring the load and providing direct feedback on the weight to the patient while walking could enhance the guidance and application of the permissible weight load for the patient, thereby improving the clinical outcome. The aim of this study is to determine whether patients after orthopedic surgical procedures adhere better to the prescribed load limits when instructed using a biofeedback method that provides visual and auditory feedback on the load via pressure measurement insoles, compared to patients guided by the standard method using a personal scale. In this randomized controlled study, both methods for guiding partial loading will be examined and compared in a total of 60 patients. Patients will be measured and assessed after an introductory instruction to determine the proportion of steps exceeding the permissible load limit. This measurement will be repeated after a 6-week trial phase.
(BASEC)
Intervento studiato
The intervention group receives instructions on the permissible weight load using a pressure measurement insole placed in the shoe (STAPPONE Rehab, Vienna). The weight load applied to the foot is measured and displayed to the patient both visually and audibly via a smartphone app. The insole is used during daily movements such as walking or climbing stairs. The instruction is provided by a trained physiotherapist and is continuously conducted at home during the first 6 weeks post-surgery. The control group receives instructions for partial loading according to the standard method. The permissible weight is demonstrated to the patient once using a personal scale while standing and is then to be implemented while walking (without the scale). The guidance is also provided by a trained physiotherapist.
(BASEC)
Malattie studiate
Patients with prescribed partial loading of 15kg for at least 6 weeks after surgery on the lower extremity
(BASEC)
Prescribed partial loading of 15kg for at least 6 weeks Unilateral injury of the lower extremity Ownership of a smartphone (BASEC)
Criteri di esclusione
Patients with permitted full loading or prescribed full unloading Injury to the upper extremity that prevents the use of walking aids Neurological conditions affecting gait (BASEC)
Luogo dello studio
Basilea
(BASEC)
Sponsor
Universitätsspital Basel
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Marlene Mauch
+41612659444
marlene.mauch@clutterusb.chUniversity Hospital Basel
(BASEC)
Informazioni generali
Department of Orthopaedics and Traumatology, University Hospital Basel,
+41 61 26 59444;+41 61 26 59444
marlene.mauch@clutterusb.ch(ICTRP)
Informazioni generali
Department of Orthopaedics and Traumatology, University Hospital Basel
(ICTRP)
Informazioni scientifiche
Department of Orthopaedics and Traumatology, University Hospital Basel,
+41 61 26 59444;+41 61 26 59444
marlene.mauch@clutterusb.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
16.02.2024
(BASEC)
ID di studio ICTRP
NCT06426576 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Application of Load Limits After Orthopaedic Surgery With Biofeedback-based Instructions Compared to a Conventional Method (BASEC)
Titolo accademico
Application of Load Limits After Orthopaedic Surgery With Biofeedback-based Instructions Compared to a Conventional Method (ICTRP)
Titolo pubblico
Load Limits After Orthopaedic Surgery: Biofeedback vs. Conventional Method (AppPWB) (ICTRP)
Malattie studiate
Surgery (ICTRP)
Intervento studiato
Other: Standard one-off instruction using a scaleDevice: Plantar pressure insoles (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria:
- Patients with prescribed partial weight bearing (joint-independent) for at least 2
weeks
- Unilateral injury of the lower extremity
- Having their own smartphone
- Age 18 years and older
Exclusion Criteria:
- Patients with prescribed full weight bearing
- Patients with prescribed complete unloading
- Patients with prescribed self-selected loading "according to pain"
- Bilateral injuries of lower extremities
- Upper extremity injuries precluding the use of crutches
- Use of walking aids prior to injury
- Neurological conditions affecting gait
- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, dementia, etc.,
- Previous enrolment in a clinical trial
- Body mass > 135 kg
- Age under 18 years (ICTRP)
non disponibile
Endpoint primari e secondari
Proportion of steps (%) over of the prescribed weight bearing limit on the injured leg while walking, assessed with the instrumented insoles. (ICTRP)
Assessment of perceived pain;Assessment of physical activity;Assessment of mobility;Assessment of the quality of life;Assessment of perceived load applied;Assessment of the usability of the planar pressure insoles (intervention group only) (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Marlene Mauch, Dr.;Marlene Mauch, Dr.;Marlene Mauch, Dr., marlene.mauch@usb.ch, +41 61 26 59444;+41 61 26 59444, Department of Orthopaedics and Traumatology, University Hospital Basel, (ICTRP)
ID secondari
2024-00106, mu24Mauch (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06426576 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile