Monitoring of Weight Bearing Protocols Via Mobile Application and Pressure Sensors.
Condition: Osteochondral Lesion of Talus
Study type: Interventional

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.
    

Intervention name(s): With WBM smart insole system to monitor compliance of specified weight bearing limits data in live feedback on and off situations
Intervention type(s): Device
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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)
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Device Feasibility
Keywords: Weight bearing monitoring,; Live-biofeedback; Lower extremity; Rehabilitation; WBM smart insole system