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

The Effects of Monitoring Weight Bearing Protocols Following Lower Extremity Surgeries Via Mobile Application and Pressure Sensors.

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.

Study Overview

• Status: Completed
• Conditions: Osteochondral Lesion of Talus
• Intervention / Treatment: Device: With WBM smart insole system to monitor compliance of specified weight bearing limits data in live feedback on and off situations

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Marmara University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monitoring the compliance with weight bearing protocol	number of times above the specified upper threshold, the number of failures to reach the specified lower threshold, percentage of steps in correct weight bearing range parameter will be monitored by the device (insole with pressure sensors)	Post-op every day for 6 weeks
Visual Analog Scale	Visual Analog Scale for Pain (VAS-Pain): a pain rating scale based on self-reported measures of symptoms. A 10cm line numbered from 0 to 10 represents a continuum between "no pain" (zero) and "worst pain" (ten). It can also be interpreted as a 0-to-100 points score. This scale will be used for assessment of patient's pain levels after activity and at rest	Post-op every day for 6 weeks, post-op 12 week, post-op 24 week

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Study Chair: İlkşan Demirbüken, Assoc.Prof., Marmara University; Principal Investigator: Ender Ersin AVCI, MsC, Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): August 10, 2022

Study Registration Dates

• First Submitted: November 28, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Lower extremity; Weight bearing monitoring,; Live-biofeedback; WBM smart insole system
• Other Study ID Numbers: 09.2019.593

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No