- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07603258
Access-H20: Sensor-driven Smart Faucet Related Study
Access-H20: Sensor-driven Smart Faucet to Enable and Empower Independent Drinking and Grooming for Individuals Impacted by Spinal Cord Injury
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 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.
Přehled studie
Detailní popis
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, the investigators 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 Phase I 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 enhanced 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 of the refined faucet. The Year 1 testing was conducted in a clinical setting. The specific aims of the clinical assessment were to evaluate the 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). Besides the unique water floor technology, the Access-H2O™ faucet system equips hand-free methods for water access and water temperature control:
- Voice control via keyword recognition using Alexa integration
- Motion control using a time-of-flight (ToF) proximity sensor
- Wireless remote control with tactile buttons (newly introduced in Phase II)
- Raised spout (+5 cm) and re-angled water stream for seated face washing and hair rinsing
- Temperature control system using PID logic and a 40°C thermal safety cap There are three control sensors: voice, motion, and remote controls. Voice recognition is enabled through integration with a pre-existing Amazon Alexa device using a custom Alexa Skill. Users activate the system by saying "Alexa" followed by predefined commands (e.g., "Faucet on" or "Turn on Grooming Mode") to control faucet operation, mode selection, and temperature hands-free. Motion detection is implemented using ToF proximity sensors mounted at the base of the faucet to detect hand motion to activate the faucet for water dispensing. A handheld wireless remote control that provides an alternative input method for operating the faucet with maximal flexibility in placement and use. The remote communicates with the faucet via Bluetooth and allows users to activate or deactivate water flow and select among predefined water delivery modes. The remote may be positioned on a nearby surface or affixed using hook-and-loop fasteners, allowing users to locate the control within comfortable reach. On the front of the control, three buttons labeled "F," "W," and "G" correspond to fountain, washing, and grooming, respectively.
In the Year 1 testing, a total of 18 subjects living with SCI, called SCI subjects, and 5 control subjects were recruited in an outpatient rehabilitation clinic. Controls without limitations in head, trunk, or arm movement were used to verify that all faucet functions operated correctly and that water was accessible for drinking, rinsing, and grooming. This preliminary assessment by the controls was conducted after installing the Access-H2OTM faucet in the rehabilitation clinic and before SCI subjects' participation.
The useability testing was conducted to test the faucet's voice, motion, and remote control sensors for SCI subjects' ADLs - drinking, grooming, or washing (optional). We sought answers to the following questions: 1) Can the test participants use voice, motion, and remote controls to activate the faucet to get their mouth to drink/hydrate? 2) Can the test participants use the three controls to rinse a quarter-sized area of soap partially or fully from their left or right cheek or 3) can the test participants use the three controls to wash a quarter soap in hairs.
In the Year 1 testing, all SCI subjects who relied on wheelchairs were seated in their own manual or power wheelchairs. The wheelchairs were positioned in front of a sink equipped with the Access-H2OTM faucet. Sufficient space was provided to accommodate the subjects' legs under the sink, ensuring standardized data collection. Then, the physical therapist who provided scripted instructions to each participant on how to turn on the faucet, and then turn off the faucet. During setup, the system was tested and calibrated to ensure proper operation. If any function did not meet the standard, manual adjustments were made as needed. For example, during setup, flow and spray angles for fountain mode and grooming mode can be customized by adjusting valve angles or water pressure to achieve the preferred water flow trajectory.
Once the system was ready, each SCI subject was asked to place his or her hand by the motion sensor (motion control), use a speech speaker (voice control), and push the remote control to activate water output modes for drinking, grooming, or washing. Each participant performed the same activity (drinking, grooming, or washing) and sensor controls (voice, motion, and remote) three times. For example, a subject used the voice control to activate fountain mode for drinking and repeated the procedure three times. A total of 27 tests were conducted (3 sensors x 3 modes x 3 repetitions). Each activity was recorded "complete," "partially complete," or "unable to complete." The investigators also recorded the time it took for each subject to complete each activity.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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Virginia
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Norfolk, Virginia, Spojené státy, 23508
- Monarch Physical Therapy Clinic
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- ages 18 to 90 years old
- screened by a physical or occupational therapist to verify your spinal cord injury (SCI),
- able to follow instructions,
- able to move their eyes and head up, down, and right to activate sensors
- able to safely access a bathroom at home.
Exclusion Criteria:
- have cognitive deficits, mental health, or medical conditions that would keep them from participating in this study
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Proveditelnost zařízení
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Jiný: Faucet Water Output Activation
Arm Description: 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."
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Přístup k H2OTM Faucetu je inteligentní faucet bez rukou, který je navržen pro snadný přístup k vodě pro fyzické omezení
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Participants with Water Output Mode Activation
Časové okno: From the start of testing to the completion up to 4 hours
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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 were recorded as "task completed", "task partially completed", and "not completed" using the Access H2O faucet for drinking, grooming and washing.
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From the start of testing to the completion up to 4 hours
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Anna Jeng, ScD, Old Dominion University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- R43HD108061 (Grant/smlouva NIH USA)
- 2R44HD108061-02 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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