Access-H20: Sensor-driven Smart Faucet to Enable and Empower Independent Drinking and Grooming for Individuals Impacted by Spinal Cord Injury
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of Participants with Water Output Mode Activation
研究概览
简要总结
The objective of the SBIR Phase II study is to evaluate the updated Access-H2O™ system, a sensor-driven smart faucet developed during the Phase I SBIR project, to enhance independent drinking and grooming among individuals with spinal cord injury (SCI) in both clinical and home settings. SCI significantly impairs functional independence and the ability to perform activities of daily living (ADLs), with greater loss of function associated with higher and more complete injuries. In particular, individuals with injuries above the C5-C7 level often experience substantial upper extremity impairment, limiting their ability to use their arms and hands for essential tasks such as eating, drinking, and grooming. Access to water is therefore critical for supporting independence and facilitating the successful completion of ADLs in this population.
The commercialization of a smart faucet system capable of automatically delivering water at target temperature, flow rate, and nozzle settings tailored to specific ADLs has the potential to substantially improve independence and quality of life for individuals with SCI. The Access-H2O™ faucet was developed and tested during the SBIR Phase I project in 2024 and was subsequently upgraded and refined based on Phase I findings. Participants with SCI, along with control participants, were recruited to evaluate the feasibility and usability of the enhanced faucet system in both clinical and in-home settings. The updated system incorporates voice, motion, and remote-control interfaces to regulate water flow and temperature for ADLs, including drinking, grooming, and washing.
详细描述
Conventionally, a bathroom faucet includes a hot and cold-water knob used to control flow of water through the faucet, which is utilized for hand washing, face washing, rinsing after brushing, etc. However, existing faucets are inconvenient to use for purposes other than conventional hand washing, unhygienic, and result in wasting large amounts of water. Existing faucets make it difficult for individuals with cervical spinal cord injury (SCI) to carry out basic activities of daily living (ADLs), such as drinking, rinsing their mouths, and washing their faces.
To address these challenges, Nasoni Inc. develop the new faucet, Access H2OTM faucet, to address these challenges. During the Phase I study from 2022-2023, we achieved the following objectives: 1) Successfully designing and producing a prototype of the Access H2O faucet that met input specifications in bench testing, and 2) Developing control algorithms using sensor-based inputs successfully allowed both control and SCI subjects to accurately access desired water. The clinical feasibility study showed that the faucet could improve water access for SCI subjects and improve their ADLs. SCI subjects showed a strong preference for Access-H2O faucets compared to traditional methods.
Before proceeding with commercialization, it is necessary to optimize the operational functions of the prototype. In the Phase II study, the engineering team has planned to enhance the prototype's faucet form factor design and sensors based on the findings from the Phase I study. These enhancements include: 1) optimizing the form factor and nozzle water delivery, 2) refining the sensor & display components, and 3) expanding sensor integration capabilities. Also, the team has improved the water control mechanisms established in Phase I by integrating Access-H2O faucet intelligent algorithms and developing a supporting digital platform with a mobile app to support product efficacy, usability, and field maintenance.
Specifically, Phase II evaluates improvements in faucet form factor, sensor placement, manufacturing-ready hardware, and interaction modalities, all informed by Phase I user feedback and clinical observations. Accordingly, the objective of this Phase II study is to assess system refinements that impact real-world independence and usability beyond initial feasibility. The Phase II study comprises two sets of studies conducted in Year 1 and Year 2 separately. They were labelled as the Year 1 testing study and the Year 2 testing study.
The Year 1 testing was conducted in a clinical setting. The specific aims of the feasibility assessment were to evaluate the feasibility and usability of the refined Access-H2O™ faucet system-controlled via voice commands, hand motion, and a wireless remote-to drink water (drinking), rinse the face (grooming), or wash hair (washing; optional).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Year 1 study:
- •Inclusion Criteria:
- •Individuals with ages 18 to 90 years old are eligible for the study. Individuals should have been screened by a physical or occupational therapist to verify your spinal cord injury (SCI), they are able to follow instructions, they are able to move their eyes and head up, down, and right to activate sensors, and they are able to safely access a bathroom at home.
排除标准
- •Individuals have cognitive deficits, mental health, or medical conditions that would keep them from participating in this study.
- •Year 2 study:
- •(1) age 18 years or older with a confirmed diagnosis of SCI; (2) residence in a home environment that can support installation of the Access H2O™ smart faucet; (3) ability to provide informed consent or have a legal guardian provide consent on their behalf; (4) stable health status, as determined by clinical evaluation; (5) ability to move the head up, down, left, and right to activate sensors; (6) ability to safely access the sink area where the Access H2O™ faucet is installed; and (7) literacy and ability to follow instructions within the Access H2O™ mobile app.
- •(1) severe cognitive impairment that prevents the participant from using the device as intended; (2) any medical condition that contraindicates the use of the Access H2O™ smart faucet; and (3) participation in another clinical trial that could interfere with the outcomes of this study.
研究组 & 干预措施
Faucet Water Output Activation
Year 1 Study (in Clinic):
Each subject was instructed to activate the water output modes for drinking and grooming using three different control methods of the faucet: placing their hand near the motion sensor (motion control), using a speech speaker (voice control), and using a remote sensor. For each activity of daily living (drinking and grooming), the physical therapist rated and recorded as "task completed", "partially completed", and "not completed."
Year 2 study (at home):
Each subject was instructed to activate the water output modes for drinking and grooming using three different control methods of the faucet: placing their hand near the motion sensor (motion control), using a speech speaker (voice control), and using a remote sensor. For each activity of daily living (drinking and grooming), the physical therapist rated and recorded as "task completed", "partially completed", and "not completed."
干预措施: Water Faucet (Device)
结局指标
主要结局
Number of Participants with Water Output Mode Activation
时间窗: 2 days
Each subject was measured to determine whether he or she can complete using the Access H2O faucet in clinic for drinking, grooming, and washing. Primary outcomes include "task completed", "task partially completed", and "not completed."
Number of Participants with Water Output Mode Activation
时间窗: 14 days
Each subject was measured to determine whether he or she can complete using the Access H2O faucet in the subject's residential bathroom for drinking, grooming, and washing. Primary outcomes include "task completed", "task partially completed", and "not completed."
次要结局
未报告次要终点
研究者
Anna Jeng
Professor
Old Dominion University
