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Monitoring of Weight Bearing Protocols Via Mobile Application and Pressure Sensors.

NCT04194970 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-08-19

No results posted yet for this study

Summary

Randomized, prospective, double-blind study: Avascular, anöral and non-regenerative cartilage tissue mostly repaired via arthroscopic surgeries. After that, the patients rehabilitate with optimum weight bearing protocols in post-operative and discharge periods by physiotherapists. In the post-operative period, optimum weight bearing is vital for this tissue healing. There is not any opportunity or device to follow up the compliance of patients to weight bearing. We aimed to develop a device with mobile application to monitor the compliance the patients to weight bearing protocols. This device is designed to could give negative live feedback (with visual audible and vibrating warnings) in order to ensure the compliance of patients. Thanks to the device, health professionals will also have the opportunity to monitor the patient's compliance with the protocol on a daily basis. We hypothesized that patients monitored with this device may have a better recovery.

Conditions

  • Osteochondral Lesion of Talus

Interventions

DEVICE

With WBM smart insole system to monitor compliance of specified weight bearing limits data in live feedback on and off situations

Weight Bearing Protocol (Duration: Post-Op. 6 week) * Post-op 3 week non-weight bearing (%0 body weight of patient) * Post- op 3 week touch down weight bearing (%10-%20 body weight of patient) Group I - monitoring with device while the live feedback mechanism turned on Group II- monitoring with device while the live feedback mechanism turned off

Sponsors & Collaborators

  • Marmara University

    lead OTHER

Principal Investigators

  • İlkşan Demirbüken, Assoc.Prof. · Marmara University

  • Ender Ersin AVCI, MsC · Marmara University

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2022-05-30
Completion
2022-08-10

Countries

  • Turkey (Türkiye)

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 NCT04194970 on ClinicalTrials.gov