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

NCT ID: NCT04194970

Last Updated: 2022-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-08-10

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.

Detailed Description

The cartilage tissue, reduces the friction forces in the joints and distributes loads on the joints, is damaged by aging, trauma exposure and degeneration. This tissue is avascular, aneural and non-regenerative. To repair the damaged cartilage tissue arthroplasty method is mostly chosen and the surgery of talus osteochondral lesions is mostly performed type among them. In the post-operative period, optimum weight bearing is vital for this tissue healing. Optimum weight bearing means that the repaired tissue is loaded by a weight which is in between specific percentage of the body weight. During the healing process, educating and compliance of the patients about optimum weight bearing in hospital and after discharge it is difficult to ensure continuity of compliance. At that point the clinical problem arises in terms of teaching the patients the preferred weight bearing percentages (protocols) and their compliance on weight bearing protocols both in hospitalization and home care period. There is not any opportunity or device to follow up the compliance of patients to weight bearing protocols after discharge. A research stated that as the pain symptom decreases, the compliance of patients to optimum weight bearing protocols disappear in home care period even if they had adhered the taught protocol at the clinic. The loss of compliance in the postoperative rehabilitation phase can delay repaired tissue healing and often revision surgery be necessary. This situation necessitated the follow-up of the patients by the physiotherapist using the live-feedback systems. For this purpose, we aimed to develop an android mobile application (system) that will work synchronized with pressure sensors placed under an insole (device). The producing and effectiveness research of mentioned device will consist of two stages. At the first stage will be about product development and testing with volunteer healthy participants. At the second stage named as testing its applicability on patients. The patients will be randomized to two group as Group I (rehabilitate with live-feedback system) and Group II (rehabilitate via system without live- feedback) to evaluate the effectiveness of the live-feedback and mentioned system. The volunteer patients will be evaluated each day, in term of compliance with the weight bearing protocol for 6 weeks. The American Orthopedic Foot Ankle Society, Ankle-hindfoot (AOFAS-AHF) scoring will be administered to each patient on preoperative day and 6 weeks after surgery in order to be evaluate assess the effectiveness of clinical recovery. We expect, thanks to this live feedback system, the health professionals to be capable of determining and monitoring of patients' weight bearing percentages to the body weight during their healing process. Also, the patient will be alerted by the system with visual audible and vibrating warnings, if non-compliance with the weight bearing protocol. Thus, patients can do their own follow-up without a health professional. In this way, continuity of compliance could be ensured. We hypothesized that the development of the insole is expected to help overcome the clinical difficulties encountered during the rehabilitation process and reduce the need for revision operations.

Conditions

Osteochondral Lesion of Talus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: DOUBLE

Study Groups

Group I (monitoring with live-feedback system)

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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 II (monitoring without live feedback)

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Ender Ersin Avci

Research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

İlkşan Demirbüken, Assoc.Prof.

Role: STUDY_CHAIR

Marmara University

Ender Ersin AVCI, MsC

Role: PRINCIPAL_INVESTIGATOR

Marmara University

Locations

Marmara University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

09.2019.593

Identifier Type: -

Identifier Source: org_study_id