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Completed

NCT Number: NCT04194970

Monitoring of Weight Bearing Protocols 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

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

    Time frame: pre-operative day, post-op 6 week, post-op 12 week, post-op 24 week

    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.

Other outcomes

  1. Monitoring the compliance with weight bearing protocol

    Time frame: Post-op every day for 6 weeks

    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)

  2. Visual Analog Scale

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

    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

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 11, 2019
Registry last updated
Aug 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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