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Evaluation of the Effect of Biofeedback on Osseous Union Using Pedobarography After Mid- and Hindfoot Arthrodesis

NCT04732884 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2024-10-22

No results posted yet for this study

Summary

The current study aims at evaluating the effect of biofeedback of correct partial weight bearing on the rate of osseous non-union compared to conventional patient instruction without biofeedback.

Conditions

  • Complication of Surgical or Medical Care

Interventions

DEVICE

Smartsens, Gelenic AG; with biofeedback

The Smartsens is a CE certified 4-cell load sensor integrated in an insole that can be placed in any orthosis or cast. A threshold (10-50kg) can be defined at which - if higher loads are measured - an audio signal warns the patient of overloading (biofeedback). The device additionally registers loads from 0-100kg continuously.

DEVICE

Smartsens, Gelenic AG; without biofeedback

Patients will not be warned by an audio signal in case of overloading. The device registers loads from 0-100kg continuously.

Sponsors & Collaborators

  • Prof. Dr. med. Arno Frigg

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-25
Primary Completion
2026-08-31
Completion
2027-01-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04732884 on ClinicalTrials.gov