Medical Policy

This document addresses the use of rehabilitative devices with remote monitoring and adjustment capabilities intended to evaluate and improve muscle strength and range of motion (ROM) while reporting session data to the individual’s provider.

Note: Benefit exclusions regarding exercise equipment may apply.

Note: This document does not address mobile device-based health management applications. For more information regarding such service, please see:

• CG-ANC-08 Mobile Device-Based Health Management Applications
• CG-DME-10 Durable Medical Equipment

Note: For a high-level overview of this document, please see “Summary for Members and Families” below.

Investigational and Not Medically Necessary:

The use of rehabilitative devices with remote monitoring or adjustment capabilities is considered investigational and not medically necessary for all indications.

This document describes clinical studies and expert recommendations, and explains why rehabilitative devices with remote monitoring are not considered clinically appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Rehabilitation devices with remote monitoring and adjustment are tools used at home to help improve muscle strength and joint range of motion (ROM) after surgery or injury, or to help manage foot ulcers in people with diabetes. These devices can send information to a doctor and may allow the doctor to adjust settings from a distance. Examples include the PortableConnect^® (ROMTech, Brookfield, CT), AccuAngle^® (ROMTech, Brookfield, CT), and Smart Boot^TM (Sensoria, Redmond, WA). While these devices can track movement and use, current research has not shown that they improve long term health outcomes at least as well as standard rehabilitation or offloading treatments.

What the Studies Show

These devices are designed to support recovery. The PortableConnect works in a way that is similar to a seated exercise bike. It adjusts to a person’s knee motion and sends data about time, effort, and ROM to a doctor. The AccuAngle is worn on the leg and measures knee bending and straightening. The Sensoria Smart Boot is worn by people at risk for diabetic foot ulcers (DFUs) and tracks whether the boot is worn as prescribed. It sends updates to a doctor about use and activity.

Some studies suggest that people using a home based remote physical therapy system after knee replacement had less pain and better knee motion in the first 12 weeks compared with standard in person therapy. However, this study was not randomized, was done in one surgeon’s practice, and therapists knew which treatment people received. These factors may have affected the results. Other studies of the Sensoria Smart Boot mainly tested how well it measured steps or detected whether the boot was worn. These studies were small and often included healthy adults instead of people with foot ulcers. They did not measure long term healing or health outcomes. Larger, well designed studies are needed to know if these devices improve health compared with standard care. There are no nationally recognized guidelines that recommend these remote monitoring rehabilitation devices for any medical use.

Is this Clinically Appropriate?

The use of rehabilitation devices with remote monitoring or adjustment is not clinically appropriate because it has not been proven to improve health. Studies so far mainly show that the devices can collect and send data accurately. They do not clearly show better long term recovery, better wound healing, or better overall function compared with standard rehabilitation or standard offloading devices. Better studies are needed to know if these devices improve health.

Rehabilitation devices with remote monitoring or adjustment are not clinically appropriate for any condition. Using devices that have not been proven to improve outcomes may delay the use of proven treatments and expose people to inconvenience or false reassurance without clear benefit. Unnecessary or unproven services can lead to treatment that does not help.

(Return to Description/Scope)

Summary

This document addresses rehabilitative devices with remote monitoring or adjustment capabilities designed to improve muscle strength and range of motion (ROM) while transmitting session data to a clinician. Examples include the ROMTech PortableConnect, ROMTech AccuAngle, and Sensoria Smart Boot systems. Available evidence consists primarily of small feasibility studies, retrospective analyses, and proof-of-concept evaluations demonstrating technical accuracy and user acceptability, but with limited data on long-term functional outcomes or comparing effectiveness to standard rehabilitation approaches. Professional societies and systematic reviews emphasize the importance of structured rehabilitation after knee arthroplasty and consistent offloading for diabetic foot ulcer (DFU) management, but do not specifically recommend remote-monitoring rehabilitation devices as part of standard practice. Overall, current literature supports technical feasibility and monitoring capability, while larger prospective studies are needed to clarify clinical impact and optimal integration into rehabilitation protocols.

Discussion

Summers and colleagues (2023) compared outcomes following total knee arthroplasty between a home-based, remote clinician-controlled physical therapy system and a standard physical therapy protocol. The retrospective study included 270 individuals undergoing primary total knee arthroplasty for osteoarthritis. Individuals with bilateral procedures, prior ipsilateral knee surgery, or deformities requiring higher implant constraint were excluded. Outcomes were reviewed for consecutive cases performed by a single surgeon during the 6 months before and 6 months after adoption of the home-based device. Individuals treated before implementation comprised the standard therapy protocol (STP) group (n=135), while those treated after adoption formed the home-based clinician-controlled therapy system (HCTS) group (n=135). The STP group completed at least 4 weeks of outpatient therapy 2 to 3 times per week, whereas the HCTS group used the in-home device without additional formal therapy. Therapy exposure differed substantially, with the HCTS group averaging 2.9 sessions per day compared with 2 to 3 sessions per week in the STP group. The HCTS group also had less pain after 2 weeks (6.2 vs. 7.7), 6 weeks (3.6 vs. 5.2), and 12 weeks (1.4 vs. 2.9) compared to the STP group (all statistically significant with p<0.0001). Knee ROM was consistently greater in the HCTS group compared to the STP group at all measured time points. After 2 weeks of therapy, mean total knee ROM was 97 degrees (range 69-122) in the HCTS group compared to 83 degrees (range 45-102) in the STP group (P<0.0001). At 6 weeks, ROM improved to 114.9 degrees (range 88-131) in the HCTS group compared with 98.1 degrees (range 73-124) in the STP group (p<0.0001). By 12 weeks, total knee ROM reached 125.2 degrees (range 103-135) in the HCTS group compared to 117.6 degrees (range 102-132) in the STP group (p<0.0001). Limitations include the retrospective design and non-randomized, sequential cohort structure (6 months before and after device adoption), which introduces potential temporal and confounding biases. The study was conducted at a single practice with therapy staff employed by the surgeon, limiting generalizability and introducing possible performance bias; outcome assessors were not blinded to treatment group. Preoperative ROM was visually estimated rather than measured with goniometry, and the HCTS group had brief in-person therapist contact during follow-up visits, meaning the intervention was not purely remote. Larger prospective randomized trials across multiple centers are needed to confirm durability and external validity.

Park (2022) reported on a proof-of-concept study that evaluated the feasibility, technical accuracy, and short-term functional effects of a Smart Boot system, an offloading boot integrated with an inertial sensor, smartwatch application, and cloud-based dashboard, to enable remote monitoring of adherence and physical activity in individuals at risk for DFUs. For the study, 14 healthy adults performed daily activities and balance/gait assessments with and without the Smart Boot. The system demonstrated high accuracy for detecting adherence and non-adherence, with sensitivity of 90.6%, specificity of 88.0%, and overall accuracy of 89.3%. Balance testing showed significantly reduced center-of-mass sway while wearing the boot across stance and vision conditions, suggesting enhanced stability potentially due to mechanical ankle support and somatosensory feedback. Step count estimation was feasible but demonstrated variable error, particularly at normal walking speeds. User experience surveys indicated strong acceptance, with most participants reporting ease of use, comfort, low intrusiveness, and willingness to recommend the device. The authors conclude that the Smart Boot represents a promising platform for reinforcing adherence and enabling remote clinician oversight, which may ultimately improve DFU outcomes. Limitations included a small sample of healthy volunteers rather than individuals with DFUs, limiting generalizability to the target population. Adherence testing occurred over a short laboratory-based session rather than in real-world longitudinal use. Step-count error was substantial at certain walking speeds, reflecting algorithm limitations and connectivity challenges between the boot and smartwatch. The clinical dashboard functionality was described but not evaluated in care context. The study did not assess wound healing outcomes or adherence durability over time. Additionally, some authors had industry affiliations with the device manufacturer, introducing potential conflict-of-interest considerations. Larger, longer-term trials in individuals with active DFUs are needed to validate clinical effectiveness and real-world impact.

In a review article Bus (2024) discusses contemporary advances in offloading technologies and strategies to improve adherence in the prevention and treatment of DFUs, emphasizing footwear innovation, remote sensor monitoring, smart insoles, and integrated digital health systems. The author highlights that while non-removable devices remain the gold standard for ulcer healing, poor adherence to removable devices and therapeutic footwear substantially limits effectiveness. The review outlines multifaceted approaches to enhance adherence, including personalized footwear solutions (e.g., indoor versus outdoor custom shoes), remote pressure monitoring using smart insoles with real-time alerts, gamification and visual feedback systems to reinforce behavior, and integrated platforms such as Smart Boot that combine inertial sensors, wearable feedback, and clinician dashboards. Emerging technologies such as AI-driven predictive models and telehealth platforms are also discussed as tools to individualize care and proactively identify adherence challenges. Collectively, the review argues that integrating sensor technology and digital health infrastructure with offloading devices offers significant potential to improve pressure redistribution, engagement from the individual, and ultimately DFU healing and recurrence prevention. Limitations include the narrative (non-systematic) design, which lacks formal methodology for literature selection and may introduce selection bias. Much of the cited evidence consists of small proof-of-concept trials, feasibility studies, or early-stage clinical investigations, limiting definitive conclusions about long-term effectiveness. Some highlighted technologies, including smart insoles and Smart Boot systems, require larger, multicenter randomized trials to confirm scalability and clinical impact. Robust evidence demonstrating sustained improvements in ulcer healing rates and long-term adherence in diverse real-world populations remains limited.

A study by Cay (2025), evaluated the validity, adherence detection accuracy, and user acceptability of the Smart Boot system, a sensor-integrated offloading boot using edge computing and smartwatch feedback, for remote monitoring of step count, cadence, and adherence in DFU management. In a controlled validation protocol, 12 healthy participants wore 2 offloading devices (DH Walker by Össur and Foot Defender) instrumented with the Sensoria Core sensor while walking at slow, habitual, and fast speeds. Smart Boot-derived cadence and step counts were compared against a validated wearable gait system and observer logs. Results demonstrated low measurement bias and high precision across speeds, with cadence bias under approximately 5.5% and step-count error lowest in the Foot Defender condition. Adherence detection accuracy reached 96-97%, with high sensitivity but slightly lower specificity due to minor detection lags when the boot was removed. User acceptability was assessed using a Technology Acceptance Model (TAM) survey in both healthy participants (n=12) and a separate cohort of 81 individuals with DFUs, showing high perceived usefulness, ease of use, and intention to use, particularly for the Foot Defender boot. The authors conclude that Smart Boot is a valid and scalable tool for real-time monitoring of offloading adherence and mobility biomarkers relevant to DFU healing and frailty assessment. Limitations include validation conducted exclusively in healthy individuals rather than individuals with DFUs for gait accuracy testing, which may limit generalizability to altered gait patterns seen in clinical populations. The controlled laboratory setting may not reflect unsupervised real-world use. Observer-recorded adherence served as the reference standard rather than an independent validated commercial comparator. System performance metrics such as latency, jitter, and power consumption were not directly measured. Specificity was modestly lower due to short transmission and processing delays. The convenience sample size was small for validation testing, and between-group comparisons may be underpowered. Clinical outcome data such as wound healing were not evaluated in this analysis. Larger real-world studies are needed to confirm long-term clinical impact and scalability.

Post-operative rehabilitation after knee arthroplasty

Although it is generally accepted that rehabilitation following knee arthroplasty is essential to achieve optimal results, no single rehabilitation protocol has been established as the standard of medical practice. Moderate quality evidence suggests that multi-disciplinary rehabilitation may improve treatment outcomes. Rehabilitation programs in this setting typically address range of motion (ROM), strengthening, gait, and modification of daily activities as needed. Unresolved questions remain about the optimal setting, intensity, and frequency of therapy sessions.

ROMTech PortableConnect

The PortableConnect is a rehabilitative therapy device to increase ROM. It is similar in appearance and function to a recumbent exercise bicycle. An adaptive pedal adjusts the turning radius to the individual’s current ROM. Used in conjunction with the ROMTech AccuAngle󠄘 (see below), the device shares data on time used, effort, and ROM with a remote physician or therapist. The physician or therapist can remotely adjust settings such as active versus passive motion, resistance, and pedal radius. The manufacturer asserts that the PortableConnect^® improves recovered ROM over a 3- to 6-week treatment course.

The U.S. Food and Drug Administration (FDA) identifies the PortableConnect device as an isokinetic testing and evaluation system intended for medical purposes, such as to evaluate, measure, and increase the muscle strength and ROM. The FDA classifies this type of device as exempt from the premarket notification procedures.

ROMTech AccuAngle

The AccuAngle measures knee extension and flexion and reports these data to the individual’s app. It is placed on the side of the leg and uses Bluetooth technology to measure and report flexion and extension during each therapy session. It is used in conjunction with the PortableConnect device.

The U.S. Food and Drug Administration (FDA) identifies the AccuAngle device as an AC-powered goniometer, a device intended to evaluate joint function by recording and measuring ranges of motion and forces exerted by a joint. The FDA classifies this type of device as exempt from the premarket notification procedures.

Mechanical Offloading for Diabetic Foot Ulcer

Reducing pressure by mechanical offloading benefits ulcers subjected to frequent pressure and stress. Various types of offloading devices include shoe modifications, cast walkers, total contact cast and other devices aiding ambulation. Cast walkers are prefabricated braces designed to provide offloading capability and maintain contact fit.

Sensoria Health Diabetic Foot Ulcer Boot (Smart Boot)

The Sensoria diabetic foot ulcer boot monitors an individual’s compliance to the clinician’s prescribed stabilization and mechanical offloading rehabilitation protocol. Real-time updates on the individual’s activities and for how long the boot is taken off is provided to the clinician.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

1. Bus SA, Reeves ND, Armstrong DG, Najafi B. Offloading and adherence through technological advancements: modern approaches for better foot care in diabetes. Diabetes Metab Res Rev. 2024; 40(2):e3769.
2. Cay G, Lee M, Armstrong DG, Najafi B. SmartBoot: real-time monitoring of patient activity via remote edge computing technologies. Sensors (Basel). 2025; 25(14):4490.
3. Park C, Mishra R, Vigano D, et al. Smart offloading boot system for remote patient monitoring: toward adherence reinforcement and proper physical activity prescription for diabetic foot ulcer patients. J Diabetes Sci Technol. 2023; 17(1):42-51.
4. Summers SH, Nunley RM, Slotkin EM. A home-based, remote-clinician-controlled, physical therapy device leads to superior outcomes when compared to standard physical therapy for rehabilitation after total knee arthroplasty. J Arthroplasty. 2023; 38(3):497-501.

AccuAngle
PortableConnect
Sensoria Health Diabetic Foot Ulcer Boot
Sensoria Smart Boot

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member’s contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

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