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

NCT04194970 | Completed DMC

• 1 other identifier: 09.2019.593
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Weight bearing monitoring,; Live-biofeedback; Lower extremity; Rehabilitation; WBM smart insole system

Outcome Measures

Primary Outcomes (1)

• Evaluation the clinical recovery of osteochondral lesion of talus post operative patients.

  American Orthopedic Foot and Ankle Society- Ankle hindfoot scale will be used for this evaluation. The scale includes nine items that can be divided into three sub-scales (pain, function and alignment). Pain consists of one item with a maximal score of 40 points, indicating no pain. Function consists of seven items with a maximal score of 50 points, indicating full function. Alignment consists of one item with a maximal score of 10 points, indicating good alignment. The maximal score is 100 points, indicating no symptoms or impairments. This scale will be used for evaluation the clinical recovery of osteochondral lesion of talus post operative patients.

  pre-operative day, post-op 6 week, post-op 12 week, post-op 24 week

Other Outcomes (2)

• Monitoring the compliance with weight bearing protocol

  Post-op every day for 6 weeks

• Visual Analog Scale

  Post-op every day for 6 weeks, post-op 12 week, post-op 24 week

Study Arms (2)

Group I (monitoring with live-feedback system)

EXPERIMENTAL

WBM smart insole system is a product that can monitor the pressure under the foot and provide live feedback (if this option activated) to the user in case of exceeding the specified limits. Its components are insole with pressure sensors and mobile applications (IOS, Android). Post-operative patients (osteochondral lesion of the talus) will be monitored with the WBM smart insole system in case live feedback is turned on. We aimed to ensure the compliance of patients to specified weight bearing limits. We will follow up this grup for 6 weeks periods with WBM smart insole system. Pre-op. and post-op 6 week, we evaluate the patients in case of ankle function, pain with The American Orthopaedic Foot \& Ankle Society (AOFAS) Scoring. Also we will monitor the compliance success of patients with WBM smart insole system during 6 week. The relationship with compliance to weight bearing success and AOFAS scores will be evaluate.

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

Group II (monitoring without live feedback)

ACTIVE COMPARATOR

The post-operative patients (osteochondral lesion of talus), follow-up with product in live-feedback closed condition. After surgery, we will educate the patients about weight bearing protocol on post-op first day and post op 3 week. The protocol is " first 3 weeks, %0 body weight bearing (BWB), second 3 weeks between %10-%20 BWB". Patients' compliance to BWB protocol will be monitored daily with the WBM smart insole system in case live-feedback is turned off. Pre-op and post-op 6 week, we evaluate the patients in case of ankle function, pain with The American Orthopaedic Foot \& Ankle Society (AOFAS) Scoring. The relationship with compliance to weight bearing success and AOFAS scores will be evaluate.

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

Interventions

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

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

Group I (monitoring with live-feedback system); Group II (monitoring without live feedback)

Eligibility Criteria

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

You may qualify if:

• Patients with a symptomatic osteochondral lesion of the Talus.
• Magnetic resonance of the ankle showing osteochondral injury of a single talus
• People who can use smart phone (andoid or ios)

You may not qualify if:

• Recurrent osteochondral lesions of the talus
• Multiple osteochondral lesions
• Severe ankle instability, requiring open repair
• History of a previous foot or ankle surgery of the ipsilateral foot
• Having a systematic disorders like Diabetes Mellitus, Rheumatoid arthritis etc.
• Inability to return to the surgery site to practice long-term follow-up evaluations or lack of readiness to complete the indicated evaluation forms.
• Patients with a qualitative or quantitative commitment that prevents consent or assent their participation in the study.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

Study Officials

• İlkşan Demirbüken, Assoc.Prof.

  Marmara University

  STUDY CHAIR

• Ender Ersin AVCI, MsC

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Model Details: First Step of Research: development of product that can provide live-feedback (insole with pressure sensors, mobile application) (approximately- 10 healthy volunteers) Second Step of Research: Testing this product on healthy volunteers Third Step of Research: Following up the post-operative patients with product ( Group I - monitoring with live feedback, Group II- monitoring without live-feedback) (approximately- 10 post-operative patients)

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 11, 2019
• Study Start: January 1, 2022
• Primary Completion: May 30, 2022
• Study Completion: August 10, 2022
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)