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Spinal Cord Injury CervicalNCT06159946

Access-H20 Faucet for Spinal Cord Injury

A study testing Access-H2O faucet in people with Spinal Cord Injury Cervical, run by Old Dominion University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Phase I SBIR objective is to design, develop \& demonstrate feasibility of Access-H2OTM, a sensor driven smart faucet to enable and empower independent drinking and grooming for individuals impacted by spinal cord injury (SCI). Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Spinal Cord Injury Cervical
What is being tested?
Access-H2O faucet
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
15 Aug 2022to 15 Apr 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Quadriplegics with injuries above C7

Who cannot join

  • Subjects with cognitive deficits, serious mental health or medical conditions that would compromise subject safety or accurate user feedback will be excluded

Trial locations and contacts

1 site in 1 country.

United States1 site
  • ODU Monarch Physical Therapy Clinic

    Norfolk, Virginia, 23509

Other trials in United States

About this study

Official title: Access-H20: Sensor Driven Smart Faucet to Enable and Empower Independent Drinking and Grooming for Individuals Impacted by Spinal Cord Injury

The Phase I SBIR objective is to design, develop \& demonstrate feasibility of Access-H2OTM, a sensor driven smart faucet to enable and empower independent drinking and grooming for individuals impacted by spinal cord injury (SCI). SCI severely impacts functional independence \& ability to perform activities of daily living (ADLs). Greater function is typically lost with higher, more complete injuries. More specifically, those impacted above C5-C7 have impaired upper extremities, which limits the use of arms and hands for activities such as eating, drinking, and grooming. Functional access to water for these individuals becomes a key to increased independence and successful completion of ADLs. Therefore, commercialization of smart fountain faucets, which can automatically deliver water in target temperature, force, \& nozzle setting for a specific ADL, has the potential to empower individuals with SCI for greater independence \& and improved quality of life. Subjects with SCI and controls were recruited to test the functionality of the faucet which includes eye gaze, voice, and motion sensors to control the water stream for drinking, rinsing, and grooming.

Read the detailed description

Nearly 300,000 individuals are living with spinal cord injuries (SCI), and over 12,000 new SCI occur annually in the United States. Most SCIs involve the cervical (neck) region of the spine and cause partial or complete loss of movement of both arms, both legs, and the torso (quadriplegia). Individuals with a higher-level and more complete SCI typically have greater loss of functional movement and sensation below the level of the injury. They require greater levels of assistance for self-care and mobility. Currently, there are limited options for quadriplegics to access water to perform basic activities of daily living such as drinking. Additionally, hydration packs and straws create unsanitary conditions and can be difficult to use. The aim of the project is to develop an innovative fountain faucet to enable individuals living with SCI to access water more independently for basic activities of daily living. The faucet incorporates electromechanical controls and software programs that adjust spray outlets, spray angles, and water temperatures. A proximity sensor and voice recognition function allow users to control the faucet through a smart speaker.

The Access-H2O™ faucet was built on a robust software platform, designed to integrate seamlessly with three sensor controls-eye gaze, motion, and voice control-accommodating diverse user needs (Figure 3). It features three distinct modes: fountain mode, which provides an upward fountain flow for drinking; washing mode, which delivers a traditional downward flow for handwashing and other cleaning tasks; and grooming mode, which utilizes a spray pattern for rinsing the face.

For motion control, time-of-flight sensors enable users to activate washing mode by waving or placing a hand near the proximity-based motion sensor, and then switch to fountain mode by waving again. Additionally, these sensors allow users to adjust water temperature. The software translates sensor data into actions based on three defined detection zones-hot, warm, and cold-determined by the proximity of the user's hand to the faucet. During setup, users can configure these distances to map specific ranges for hot, warm, or cold water. For example, placing a hand closest to the sensor activates hot water, while the farthest position activates cold water.

For eye gaze control, the faucet was integrated with Tobii eye-tracking technology, combining both hardware and software. To maintain a compact design without making the faucet excessively wide, we engineered a removable escutcheon to house the eye-tracking sensors. This removable feature ensured versatility, allowing the smart faucet to be installed in both 1-hole and 3-hole sink configurations. The system enables users to activate and deactivate water flow by staring at specific sensor locations for a set duration. The sensor locations are corresponded to three faucet modes. A user can stare at the right sensor to activate the fountain mode for fountain flow for drinking, the center sensor for washing mode, and the left sensor for grooming mode. The selected mode remains active until the user looks at the same sensor again to turn it off. To prevent accidental activations, the software measures fixation duration and incorporates error-handling protocols to account for distractions or environmental factors.

For voice control, users can activate three faucet modes through spoken commands.

With Alexa or Google Assistant, they can turn the faucet on or off by saying, "Alexa, turn on washing mode." Additionally, users can select specific functions, such as "Alexa, activate fountain mode" to enable the fountain feature. To control flow duration, users can issue commands like "Alexa, run water for 10 seconds."

A total of 18 subjects living with SCI (C2-C6), called SCI subjects, and 10 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 feasibility testing was conducted to test the faucet's eye gaze, voice, and motion sensors for SCI subjects' ADLs - drinking, rinsing, and grooming. We sought answers to the following questions: 1) Can the test participants get the water from the fountain mode to their mouth to drink/hydrate? 2) Can the test participants use the fountain mode to rinse their mouths? and 3) Can the test participants use the fountain spray to rinse a quarter-sized area of soap partially or fully from their left or right cheek

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 same physical therapist who conducted the interview provided scripted instructions to each participant on how to turn on the faucet for the faucet modes, 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 move their eyes up, down, left, and right to activate the eye gaze sensor (eye gaze control) to activate water output modes for drinking, rinsing, and grooming. For example, to test eye gaze control, a subject looked at the right side of the eye gaze sensor to activate fountain mode for drinking and looked at the left side of the sensor to activate grooming mode for spray pattern flow to wash a quarter-sized area of soap from the left or right cheek. For each ADL activity (drinking, rinsing, and grooming), the physical therapist rated and recorded their levels of assistance as 1) independent, 2) modified Independent, 3) assistance required, or 4) dependent. Each participant performed the same activity (drinking, rinsing, or grooming) and sensor controls (voice, motion, or eye gaze) 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 tests was 27 (3 sensors x 3 modes x 3 repetition).

Each activity was recorded "compete", "partially complete," or "unable to complete." The investigators also recorded the time it took for each subject to complete each activity.

After completing the feasibility testing procedures, each SCI subject completed the System Usability Scale (SUS) to help the investigators gain a better understanding of users' perceptions of the Access-H2OTM faucet's effectiveness, efficiency, and ease of use (Bangor et al., 2008). The detailed procedures for determining a SUS score are described in Bangor et al. (2008). Briefly, each subject rated 10 survey questions on a scale from "strongly agree" to "strongly disagree." Each response was converted to a numerical value from 1 to 5, and the SUS score was calculated using the formula (X+Y) x 2.5, where X = Sum of the points for all odd-numbered questions -5, and Y = 25 - Sum of the points for all even-numbered questions.

Being tested
Access-H2O faucet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Access-H2O faucetDevice

    The assigned invention was developed to test the feasibility of the prototype of the Access-H2O faucet by assessing whether subjects can activate the faucet to control water outputs via the motion sensor, eye gaze, and a speech speaker. To activate the faucet via the motion sensor, each subject was asked to place his or her hand near the motion sensor. To activate the faucet via the eye gaze, each subject was asked to look directly at the eye gaze sensor. To activate the faucet via the speech speaker, each subject was asked to speak to the speaker. Each subject performed the same function three times. The water from the faucet was used for drinking, rinsing, and grooming.

Study groups in NCT06159946
Study groupRoleWhat they receive
Spinal cord injuryExperimentalEach subject was asked to place their hand by the motion sensor (motion control), use a speech speaker (voice control), and then move their eyes up, down, left, and right to activate the eye gaze sensor (eye gaze control) to control water outputs for drinking, rinsing, and grooming. Each subject performed the same task/function three times.
Receives: Device: Access-H2O faucet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Water Access for Activities of Daily Living

    Each subject could complete the tasks:

    1. Can the test participants use their voice to activate the faucet to drink water, rinse their mouths, and rinse a quarter-size area of soap, or rinse fully from their left and/or right cheeks?
    2. Can the test participants use the eye gaze mode to activate the faucet to drink water, rinse their mouths, and rinse a quarter-size area of soap, or rinse fully from their left and/or right cheeks?
    3. Can the test participants use the hand motion to activate the faucet to drink water, rinse their mouths, and rinse a quarter-size area of soap, or rinse fully from their left and/or right cheeks? Coding 1 was labeled as "complete," coding 2 as "partially complete," and coding 3 as "not completed." The "complete" means all the tasks to activate the faucet were completed; The "partially complete" means the faucet was activated, but some tasks were not completed; The "not completed" means the tasks were not completed to activate the faucet.

    Measured: The duration of time of assessment of the participant lasted for 2 to 3 hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2023
  2. Study start15 Aug 2022
  3. Primary completion15 Apr 2023
  4. Study completion15 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06159946
Sponsor's protocol ID
1R43HD108061-01A1
Other IDs
13459356
Status last verified
May 2026
First submitted
4 Oct 2023
Last updated
1 Jun 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Access-H2O faucet in people with Spinal Cord Injury Cervical, run by Old Dominion University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Water Access for Activities of Daily Living (time frame: The duration of time of assessment of the participant lasted for 2 to 3 hours.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

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