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

NCT06426576 | Completed

• 1 other identifier: 2024-00106; mu24Mauch
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

Orthopaedic surgery; Partial weight bearing; Portable measurement systems; Plantar pressure insoles; Biofeedback function

Outcome Measures

Primary Outcomes (1)

• Proportion of steps (%) over of the prescribed weight bearing limit on the injured leg while walking, assessed with the instrumented insoles.

  After 2 weeks of continuous use of the feedback-providing insoles by the intervention group, the adherence to load limits is evaluated at the follow-up visit. This assessment aims to determine if the intervention group adheres better to the prescribed weight-bearing limits compared to the control group, which did not receive feedback during this period. Both groups have the proportion of steps (%) exceeding the prescribed weight-bearing limit on the injured leg while walking assessed using instrumented insoles.

  At 2 weeks post-surgery

Secondary Outcomes (6)

• Assessment of perceived pain

  Baseline and at 2 weeks post-surgery

• Assessment of physical activity

  Baseline and at 2 weeks post-surgery

• Assessment of mobility

  Baseline and at 2 weeks post-surgery

• Assessment of the quality of life

  Baseline and at 2 weeks post-surgery

• Assessment of perceived load applied

  At 2 weeks post-surgery

Study Arms (2)

Control group

OTHER

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

Other: Standard one-off instruction using a scale

Intervention group

EXPERIMENTAL

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.

Device: Plantar pressure insoles

Interventions

Standard one-off instruction using a scale 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.

Control group

Plantar pressure insoles 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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

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

Basel, Canton of Basel-City, 4052, Switzerland

Location

Study Officials

• Marlene Mauch, Dr.

  Department of Orthopaedics and Traumatology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 23, 2024
• Study Start: March 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

CH (1)