Access-H20 Faucet for Spinal Cord Injury

NCT ID: NCT06159946

Last Updated: 2023-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-15
• Study Completion Date: 2023-04-15

Brief 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). 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.

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. These features enable precise dispensing of water at the desired temperature and volume, while a camera and other sensors enable hands-free operation. Subjects, including individuals living with SCI and controls, were recruited from an outpatient rehabilitation clinic to test the functionality of the faucet including eye gaze, voice, and motion sensors to control the water stream for drinking, rinsing, and grooming. The examiner screened the subjects to determine their levels of functional independence (independent, modified independent, assistance required, and dependent). The participants were also interviewed regarding their current methods of drinking, rinsing, and grooming. The percentage and standard deviation of individuals in each level of independence for each function were calculated. A t-test was conducted to determine any significant differences in the dependence levels between the tested subjects and the control group.

Conditions

Spinal Cord Injury Cervical

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Spinal cord injury

Each 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.

Group Type: EXPERIMENTAL

Access-H2O faucet

Intervention Type: DEVICE

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.

Interventions

Access-H2O faucet

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Quadriplegics with injuries above C7

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Old Dominion University

OTHER

Sponsor Role: lead

Responsible Party

Anna Jeng

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

ODU Monarch Physical Therapy Clinic

Norfolk, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

1R43HD108061-01A1

Identifier Type: NIH

Identifier Source: org_study_id

View Link