Implementation of Partial Load through Instruction with Biofeedback Compared to the Standard Method
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
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)
Studienstandort
Basel
(BASEC)
Sponsor
Universitätsspital Basel
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Marlene Mauch
+41612659444
marlene.mauch@clutterusb.chUniversity Hospital Basel
(BASEC)
Allgemeine Auskünfte
Department of Orthopaedics and Traumatology, University Hospital Basel,
+41 61 26 59444;+41 61 26 59444
marlene.mauch@clutterusb.ch(ICTRP)
Allgemeine Auskünfte
Department of Orthopaedics and Traumatology, University Hospital Basel
(ICTRP)
Wissenschaftliche Auskünfte
Department of Orthopaedics and Traumatology, University Hospital Basel,
+41 61 26 59444;+41 61 26 59444
marlene.mauch@clutterusb.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
16.02.2024
(BASEC)
ICTRP Studien-ID
NCT06426576 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Application of Load Limits After Orthopaedic Surgery With Biofeedback-based Instructions Compared to a Conventional Method (BASEC)
Wissenschaftlicher Titel
Application of Load Limits After Orthopaedic Surgery With Biofeedback-based Instructions Compared to a Conventional Method (ICTRP)
Öffentlicher Titel
Load Limits After Orthopaedic Surgery: Biofeedback vs. Conventional Method (AppPWB) (ICTRP)
Untersuchte Krankheit(en)
Surgery (ICTRP)
Untersuchte Intervention
Other: Standard one-off instruction using a scaleDevice: Plantar pressure insoles (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
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)
Sekundäre IDs
2024-00106, mu24Mauch (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06426576 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar