Load Limits After Orthopaedic Surgery: Biofeedback vs. Conventional Method (AppPWB)

NCT ID: NCT06426576

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-11-30

Brief Summary

The aim of this single-centre prospective randomized-controlled clinical trial is to assess whether patients adhere to prescribed weight bearing limits after surgical orthopaedic or traumatological interventions more accurately after instruction using a biofeedback method than using the standard method.

Detailed Description

Partial weight bearing, commonly prescribed post-surgery in orthopaedics and traumatology, aims to stimulate healing while preventing overloading. Partial weight bearing refers to that the patient is only allowed to put 10 to 50% of their body weight on the affected limb.

The most commonly used method for instructing partial weight bearing with the patient is using a personal scale. This means that the patient can only exercise in a static position and the perceived load must be transferred to dynamic activities of daily living without further feedback. Previous reports indicate that patients often struggle to adhere to prescribed partial weight-bearing limits, frequently exceeding the specified load by 100% or more. However, when additional feedback was incorporated into training, approximately 90% of subjects successfully adhered to the partial load.

Portable or wearable measuring systems, such as pressure-sensitive insoles, offer feedback during dynamic tasks, facilitating a smoother transition to daily activities. Unlike the standard one-time instruction using a scale, these systems provide repeated feedback at each step, promoting a higher frequency of exercises. This aids patients in developing a better sense of the correct load.

This single-centre prospective randomized-controlled clinical trial aims to investigate the effectiveness of pressure insoles connected to a smartphone via Bluetooth and operated using an app in improving partial weight bearing adherence. The insoles provide direct feedback through acoustic and visual signals if the affected leg is overloaded, possibly leading to a lower proportion of steps over the load limit compared to those without feedback. Participants are randomized into either the intervention group (dynamic condition - plantar pressure insoles) or the control group (static condition - standard one-off instruction using a scale).

The primary objective is to determine whether the proportion of steps exceeding the weight bearing limit is lower in the intervention group compared to the control group 2 weeks after surgery. Secondary objectives include assessing subjective ratings of the permitted load, perceived pain, and mobility. Additionally, the trial hypothesizes that patients using the insoles can estimate applied load more accurately. The intervention group will also provide feedback on the usability of the app and insoles.

The results of this trial will contribute to enhancing postoperative treatment of patients undergoing orthopaedic surgery, thereby improving treatment outcomes and optimizing therapy regimens.

Conditions

Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

The control group receives instructions on partial weight bearing using the standard method.

Group Type: OTHER

Standard one-off instruction using a scale

Intervention Type: OTHER

The permitted weight is demonstrated to the patient once using a scale in the static position. The patient repeatedly places the foot with the permitted weight on a scale in order to develop a feeling for the load. After this exercise in the static position, the patient applies the perceived load to dynamic activities of daily living without receiving any feedback.

The instruction is given by a trained physiotherapist. Simultaneously with the instruction, the effective weight applied on the leg will be measured using instrumented insoles without any feedback.

Intervention group

The intervention group receives instructions on partial weight bearing using a plantar pressure sole inserted into the shoe that measures the force/weight applied to the foot and indicates the applied weight to the patient both visually and acoustically via a smartphone app.

Group Type: EXPERIMENTAL

Plantar pressure insoles

Intervention Type: DEVICE

The insoles are used in both static and dynamic conditions such as walking straight along the hallway or walking stairs if applicable. Initial instruction is given by a trained physiotherapist and will be continuously applied at home using the smartphone app for 5 out of 7 days per week during the first 2 weeks after surgery.

Interventions

Standard one-off instruction using a scale

The permitted weight is demonstrated to the patient once using a scale in the static position. The patient repeatedly places the foot with the permitted weight on a scale in order to develop a feeling for the load. After this exercise in the static position, the patient applies the perceived load to dynamic activities of daily living without receiving any feedback.

The instruction is given by a trained physiotherapist. Simultaneously with the instruction, the effective weight applied on the leg will be measured using instrumented insoles without any feedback.

Intervention Type: OTHER

Plantar pressure insoles

The insoles are used in both static and dynamic conditions such as walking straight along the hallway or walking stairs if applicable. Initial instruction is given by a trained physiotherapist and will be continuously applied at home using the smartphone app for 5 out of 7 days per week during the first 2 weeks after surgery.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marlene Mauch, Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedics and Traumatology, University Hospital Basel

Locations

Department of Orthopaedics and Traumatology, University Hospital Basel, Bethesda Spital Basel

Basel, Canton of Basel-City, Switzerland

Countries

Switzerland

Other Identifiers

2024-00106; mu24Mauch

Identifier Type: -

Identifier Source: org_study_id