Submitted:
19 December 2025
Posted:
22 December 2025
You are already at the latest version
Abstract
Keywords:
1. Introduction
2. Materials and Methods
2.1. Device Identification and Dataset Development
2.2. Survey of Informational Needs of Individuals Post-Stroke
2.3. Manufacturer Outreach
- Pricing and Return Policy: Including device prices and whether a return policy is offered if the device does not meet user expectations or needs.
- Ease of Use: Information about how easy the device is to operate, whether it requires therapist supervision or can be used independently, any associated discomfort or pain, and the proportion of customers who use the device at home.
- Usage Requirements: Recommendations on the frequency and duration of use needed to achieve benefits, along with any scientific studies supporting the device’s effectiveness.
- Motivational Features: Descriptions of any features designed to keep users engaged, such as progress tracking, social networking, gamification, goal setting, or feedback.
3. Results
3.1. Characteristics of FDA-Approved Devices for Home Use after Stroke
3.2. Survey to Identify Information Priorities of Stroke Survivors
3.3. Manufacturer Responses
4. Discussion
4.1. Increasing Number of FDA-Approved Devices for Home Movement Rehabilitation After Stroke
4.2. Mismatch Between User Priorities and Available Information
4.3. Manufacturer Responsiveness and Transparency Gaps
4.4. Challenges in Reporting Therapeutic Dose and Ease of Use
4.5. Implications for Database Design and Clinical Decision Making
4.6. Limitations, Future Directions, and Recommendations for Industry Standards
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Abbreviations
| FDA | Food and Drug Administration |
| FES | Functional Electrical Stimulation |
| VR | Virtual Reality |
| AR | Augmented Reality |
| HIPAA | Health Insurance Portability and Accountability Act |
| NMES | Neuromuscular Electrical Stimulation |
| CEO | Chief Executive Officer |
| COO | Chief Operating Officer |
| SUS | System Usability Score |
| AI | Artificial Intelligence |
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| Field | Description |
|---|---|
| Name | Commercial name of the device |
| Manufacturer | Name of the company |
| Website | Official site or product page |
| FDA Code(s) | Product classification code(s) |
| Year of Approval | Year of FDA clearance or approval |
| Country | Manufacturer location |
| Price | Retail cost [$] |
| Price per Year | Annualized cost for subscriptions/rentals [$/year] |
| Trained Body Parts | Targeted body parts (e.g., hand, ankle) |
| Product Category | Type of product by technological nature |
| Return Policy | Whether a return policy is offered [Y/N] |
| Insurance Coverage | Whether coverage is available [Y/N] |
| Clinical Evidence | Existence of published validation [Y/N] |
| Ease of Use | Summary of independent use, accessibility, etc. |
| Usage Requirements | Recommended frequency and duration |
| Motivational Features | Features like feedback, goals, games, etc. |
| Category | Description |
|---|---|
| Actuated wearable | Actuated wearable device that provides active movement assistance or resistance through built-in actuators |
| Sensorized wearable | Non-actuated wearable device that uses embedded sensors to measure movement or physiological signals |
| Robot | Non-wearable, actuated device that guides or assists limb or body movements through a robotic mechanism |
| Exerciser | Non-wearable, non-actuated device that supports task-specific movement practice using embedded sensors to track performance |
| Stimulator | Functional electrical stimulation (FES) system that delivers neuromuscular or functional stimulation without being integrated into a cycling device |
| FES bike | Stationary cycling system that combines functional electrical stimulation with a cycle ergometer for therapeutic exercise |
| Motion capture software | Software system that uses cameras or sensors to track, quantify, and visualize body or limb movements |
| VR/AR headset | Virtual or augmented reality (VR or AR) system that delivers rehabilitation tasks through a head-mounted display |
| Part 1. Information the website should provide about the devices (select three as most important, three as medium, and three lower) |
| Information about how easy each device is to use |
| Risks such as discomfort or pain |
| How often and for how long do I need to use it to get a benefit |
| What amount of benefit can I expect |
| Information about what motivational features the device offers (these could be things like progress tracking, social networks, gamification, goal setting with feedback, or motivational messages) |
| Videos of people using the devices |
| User reviews |
| Information about scientific studies that support its effectiveness |
| Return policy |
| Part 2. How the website should help you find devices (rate 1 to 10) |
| Ask me for personal information about my impairments and my goals so it can make personalized recommendations for what device would be best for me. |
| Suggest devices in a way that’s easy for me to compare them. |
| Allow me to ask questions like a chatbot. |
| Be accessible on my phone. |
| Guide me through the selection process. |
| Allow me to search without guiding me or asking me questions. |
| Connect me with other people who are using a device I am interested in to help me make my decision. |
| Connect me with a salesperson from the company that makes the device so I can get more information. |
| Code | Description | Percentage |
|---|---|---|
| QKC | Interactive Rehabilitation Exercise Devices, Prescription Use | 26% |
| GZI | Stimulator, Neuromuscular, External Functional | 22% |
| IPF | Stimulator, Muscle, Powered | 19% |
| BXB | Exerciser, Powered | 10% |
| ION | Exerciser, Non-Measuring | 7% |
| ISD | Exerciser, Measuring | 5% |
| PHL | Powered Exoskeleton | 5% |
| LXJ | Interactive Rehabilitation Exercise Devices | 3% |
| JFA | Exerciser, Finger, Powered | 3% |
| HCC | Device, Biofeedback | 2% |
| PKS | Exerciser, Non-Measuring For Stroke Rehabilitation | 2% |
| QOL | EEG-Driven Upper Extremity Powered Exerciser | 2% |
| IQZ | Hand, External Limb Component, Powered | 2% |
| Frequency of use |
|---|
| Designed to be used daily. Primarily effective while being worn, however with regular use over a longer period of time, customers report general increases to their endurance and speed |
| Variable, 2-3x/week, 60 minutes |
| 30 minutes, 7 days a week |
| Many chronic patients will wear the device daily for the orthotic gait benefits |
| Recommended to exercise at least 40 minutes daily |
| We recommend one hour per day to maximize outcomes |
| 3 to 5 times a week 1-hour sessions |
| 3-5 times per week, up to 1 hour each session |
| 30 minutes, 5 days a week |
| Recommend a minimum of 15 minutes 3 times a week |
| Daily for as long as it is useful. Patient can wear the device all waking hours |
| Daily use is recommended. We recommend patients begin with one 20-minute session /day and then ramp up therapy time gradually. Neuromuscular electrical stimulation (NMES) typically yields results after several months of consistent use |
| 3 times a week for an hour |
| No response (4 companies out of the respondent companies, 28 companies out of the total) |
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