NCT07062796

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2026

Completed
Last Updated

June 10, 2026

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

July 3, 2025

Last Update Submit

June 8, 2026

Conditions

Keywords

activities of daily living

Outcome Measures

Primary Outcomes (2)

  • Number of Participants with Water Output Mode Activation

    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."

    2 days

  • Number of Participants with Water Output Mode Activation

    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."

    14 days

Study Arms (1)

Faucet Water Output Activation

OTHER

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."

Device: Water Faucet

Interventions

Access H2OTM faucet is a smart, hand free faucet that is designed for ease water access for physical limitations

Faucet Water Output Activation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monarch Physical Therapy Clinic

Norfolk, Virginia, 23508, United States

Location

Study Officials

  • Anna Jeng, ScD

    Old Dominion University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 3, 2025

First Posted

July 14, 2025

Study Start

June 3, 2025

Primary Completion

April 13, 2026

Study Completion

April 13, 2026

Last Updated

June 10, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

We don't plan to share individual participant raw data; however, aggregated and tabulated data will be published in peer-reviewed articles.

Locations