Spinal Cord Injury (=3 Years)NCT07873151
Evaluation of a Voice-Activated Call Light System for Clients With Limited Upper-Extremity Mobility
An observational study of Spinal Cord Injury (=3 Years) and Traumatic Brain Injury (TBI) Patients, run by Quality Living, Inc. at 1 site in United States.
Trial summary
The goal of this study is to evaluate whether a voice-activated call light system enables people in a rehabilitation facility who have limited use of their arms and hands to call for help more independently and reliably than with their previous call light access method. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury (=3 Years), Traumatic Brain Injury (TBI) Patients, Healthy Adult Participants
- What is being tested?
- voice-activated call light
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Only people affiliated with Quality Living, Inc., are eligible for study enrollment.
Who may be able to join
- Participants with limited upper extremity movement will be current clients at Quality Living, Inc., in Omaha, NE.
- Staff participants will be current employees at Quality Living, Inc., who routinely work with participating clients with upper extremity movement limitations.
- Family member participants will be family members of participating clients with upper extremity movement limitations.
- All participants must be 19 years of age or older.
Who cannot join
- Clients with limited upper extremity movement who cannot consistently produce the selected wake phrase due to memory or cognitive difficulties.
- Clients with limited upper extremity movement who have not retained the legal right to make their own healthcare decisions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this study is to evaluate whether a voice-activated call light system enables people in a rehabilitation facility who have limited use of their arms and hands to call for help more independently and reliably than with their previous call light access method. The study will also examine client confidence, family confidence and peace of mind, staff confidence, staff effort, system reliability, and the level of disruption to routine care. The main questions to be answered are:
- People with what etiologies benefit most from access to the voice-activated call light system?
- How reliable is the voice-activated call light system in alerting staff to a client's need for assistance?
- How confident are clients, family members, and staff in the reliability of the voice-activated system for alerting staff of a client's need for assistance?
- How does access to the voice-activated call light system compare to traditional call light systems regarding staff effort and disruption to routine care? Participants with limited upper extremity movement will use the voice-activated call light system as needed during normal daily activities for up to 90 days. At study initiation, clients with limited upper extremity movement, staff members working with those clients, and family members of the clients will complete a brief questionnaire about their experiences using the existing call light system. At approximately Days 30, 60, and 90, they will complete brief questionnaires about use of the voice-activated call light system and its effectiveness.
- Conditions
- Spinal Cord Injury (=3 Years), Traumatic Brain Injury (TBI) Patients, Healthy Adult Participants
- Being tested
- voice-activated call light
- Keywords
- tetraplegia, hemiplegia, family members, assistive technology, call light, paralysis
- Medical subject headings
- Spinal Cord Injuries, Brain Injuries, Traumatic, Quadriplegia, Hemiplegia, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
voice-activated call lightDevice
Use of a voice-activated call light will substitute for use of a standard hand-activated call light.
| Study group | Role | What they receive |
|---|---|---|
| Voice-activated call light users | Clients in a rehabilitation facility with limited use of upper limbs Receives: Device: voice-activated call light | |
| Staff members | Staff in a rehabilitation facility providing services to clients with limited use of upper limbs Receives: Device: voice-activated call light | |
| Family members | Family members of clients in a rehabilitation facility Receives: Device: voice-activated call light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of client-reported independent call light activations using voice-activated system
Change number will be determined on the basis of participant reports on the 1-, 30-, 60-, and 90-day surveys.
Measured: From time of participant enrollment until 90 days post-enrollment.
Change in client-, staff-, and family-reported confidence in client's ability to activate a call light system reliably.
Confidence change will be determined on the basis Likert-scale responses to items on the 1-, 30-, 60-, and 90-day surveys. Likert-scale responses range from "Always" to "Never."
Measured: From time of participant enrollment until 90 days post-enrollment.
Self-reported change in time staff need to help client successfully access nurse call device.
Change in staff time will be measured through responses to time-interval questions (e.g., 1-2 minutes, 3-5 minutes, >5 minutes) reported on 1-day and 90-day surveys.
Measured: From time of participant enrollment until 90 days post-enrollment.
Reliability of voice-activated call light system use by people with limited upper extremity movement.
Reliability will be measured on the basis of staff responses to multiple-choice questions on the 30-, 60-, and 90-day surveys about changes or adjustments needed to the voice-activated call light system during the period of study.
Measured: From time of participant enrollment until 90 days post-enrollment.
Willingness of participants with limited upper extremity movement, staff members, and family members to continue using a voice-activated call light device after termination of the study.
Willingness will be measured on the basis of responses to a single yes-maybe-no question on the 90-day survey.
Measured: Ninety days following study enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury (=3 Years)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quality Living, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Will Call Inc.
- Responsible party
- Sponsor
- Investigators
- Karen Hux, Study director, Quality Living, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873151
- Sponsor's protocol ID
- QualityLiving WillCall
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be available upon request to the researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Voice-Activated Call Light System for Clients With Limited Upper-Extremity Mobility
- ClinicalTrials.gov ID
- NCT07873151
- Acronym / sponsor ID
- QualityLiving WillCall
- Conditions
- Spinal Cord Injury (=3 Years), Traumatic Brain Injury (TBI) Patients, Healthy Adult Participants
- Keywords
- tetraplegia, hemiplegia, family members, assistive technology, call light, paralysis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Quality Living, Inc.University, hospital or other
- Collaborators
- Will Call Inc.
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate whether a voice-activated call light system enables people in a rehabilitation facility who have limited use of their arms and hands to call for help more independently and reliably than with their previous call light access method. The study will also examine client confidence, family confidence and peace of mind, staff confidence, staff effort, system reliability, and the level of disruption to routine care. The main questions to be answered are:
- People with what etiologies benefit most from access to the voice-activated call light system?
- How reliable is the voice-activated call light system in alerting staff to a client's need for assistance?
- How confident are clients, family members, and staff in the reliability of the voice-activated system for alerting staff of a client's need for assistance?
- How does access to the voice-activated call light system compare to traditional call light systems regarding staff effort and disruption to routine care? Participants with limited upper extremity movement will use the voice-activated call light system as needed during normal daily activities for up to 90 days. At study initiation, clients with limited upper extremity movement, staff members working with those clients, and family members of the clients will complete a brief questionnaire about their experiences using the existing call light system. At approximately Days 30, 60, and 90, they will complete brief questionnaires about use of the voice-activated call light system and its effectiveness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Voice-activated call light users | – | Device: voice-activated call lightClients in a rehabilitation facility with limited use of upper limbs |
| Staff members | – | Device: voice-activated call lightStaff in a rehabilitation facility providing services to clients with limited use of upper limbs |
| Family members | – | Device: voice-activated call lightFamily members of clients in a rehabilitation facility |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Only people affiliated with Quality Living, Inc., are eligible for study enrollment.
Key inclusion criteria (4 listed)
- Participants with limited upper extremity movement will be current clients at Quality Living, Inc., in Omaha, NE.
- Staff participants will be current employees at Quality Living, Inc., who routinely work with participating clients with upper extremity movement limitations.
- Family member participants will be family members of participating clients with upper extremity movement limitations.
- All participants must be 19 years of age or older.
Key exclusion criteria (2 listed)
- Clients with limited upper extremity movement who cannot consistently produce the selected wake phrase due to memory or cognitive difficulties.
- Clients with limited upper extremity movement who have not retained the legal right to make their own healthcare decisions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| voice-activated call lightUse of a voice-activated call light will substitute for use of a standard hand-activated call light. | Device | Family members, Staff members, Voice-activated call light users |
Primary outcome
Change in number of client-reported independent call light activations using voice-activated system
Time frame: From time of participant enrollment until 90 days post-enrollment.
Change number will be determined on the basis of participant reports on the 1-, 30-, 60-, and 90-day surveys.
Change in client-, staff-, and family-reported confidence in client's ability to activate a call light system reliably.
Time frame: From time of participant enrollment until 90 days post-enrollment.
Confidence change will be determined on the basis Likert-scale responses to items on the 1-, 30-, 60-, and 90-day surveys. Likert-scale responses range from "Always" to "Never."
Self-reported change in time staff need to help client successfully access nurse call device.
Time frame: From time of participant enrollment until 90 days post-enrollment.
Change in staff time will be measured through responses to time-interval questions (e.g., 1-2 minutes, 3-5 minutes, >5 minutes) reported on 1-day and 90-day surveys.
Reliability of voice-activated call light system use by people with limited upper extremity movement.
Time frame: From time of participant enrollment until 90 days post-enrollment.
Reliability will be measured on the basis of staff responses to multiple-choice questions on the 30-, 60-, and 90-day surveys about changes or adjustments needed to the voice-activated call light system during the period of study.
Willingness of participants with limited upper extremity movement, staff members, and family members to continue using a voice-activated call light device after termination of the study.
Time frame: Ninety days following study enrollment.
Willingness will be measured on the basis of responses to a single yes-maybe-no question on the 90-day survey.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No. Data sharing will be available upon request to the researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen Hux study director
Quality Living, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury (=3 Years) and Traumatic Brain Injury (TBI) Patients, run by Quality Living, Inc. 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 4 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 14 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in number of client-reported independent call light activations using voice-activated system (time frame: From time of participant enrollment until 90 days post-enrollment.). The study lists 5 primary outcomes in all. 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 14 Oct 2026.